Day 1 - Pharmacy-Centered HIV Research: Current Landscape and Future Frontiers
BILL KAPOGIANNIS: Good afternoon, and welcome, everyone. I am Bill Kapogiannis, the Acting NIH Director of AIDS Research, and Acting Director of the NIH Office of AIDS Research. Thank you for joining us for this important meeting organized by the NIH. Today and continuing tomorrow afternoon we will be discussing current landscape and future frontiers of pharmacy centered HIV research.
I see it as timely that this meeting follows the National HIV Testing Day, which took place yesterday. Tackling the complex challenges of HIV requires a comprehensive collaborative approach involving both outreach and partnership.
This is why nearly every NIH Institute and Center and Office contributes to HIV research, and why I am pleased to note that the meeting participants who are here today come from across the US Government community, epidemic, and business sectors.
They are key representatives actively involved with and experienced in the areas of HIV, the pharmacy space, and in most cases both. In addition, there are also over 600 people registered to attend today, and we look forward very much to your input and contributions as part of this meeting as well.
In bringing the all-hands-on-deck approach to the fight against HIV, new and improved understanding, tools, and systems of delivery are being sought and developed. COVID-19 certainly underscored and enhanced our understanding. The pharmacists, pharmacies, and pharmacy systems are vital in this approach as they ramped up in unprecedented ways to provide people access to testing and treatment services.
The updated US National HIV AIDS Strategy or NHAS highlights the role of pharmacists in the supporting of that, the Ending the HIV Epidemic or EHE in the US Initiative. Increasingly investigating and initiating expanded work within and that reaches throughout the pharmacy space.
To quote from the NHAS, better coordination involves fostering strong linkages among community-based organizations, health departments, other public programs, and services, educational agencies, pharmacies, healthcare providers, and systems, and community leaders.
Our focus over the next two days is to specifically explore and discuss how pharmacies, pharmacists, and the pharmacy workforce can best be initiators and leaders in these collaborations, making vital contributions to HIV prevention, diagnosis, treatment, and care in ways and on a scale that truly make a difference.
We will cover work already accomplished, identify where the needs and research gaps are, and discuss how we can best address them through leveraging pharmacies to their full potential as we all work together to respond to and to bring an end to HIV.
Thank you again for agreeing to be part of this important conversation today. I look forward to receiving the outcomes and conclusions of this meeting to utilize the NIH’s research planning as well as to disseminate them widely. I anticipate the outcomes of this meeting will be important to all of us in our various roles and responsibilities, especially as we work together collectively and collaboratively.
Now I have the honor of turning this over to my friend and colleague, Dr. Dianne Rausch, who is the Director of the Division of AIDS Research at the NIH’s National Institute of Mental Health for her opening comments. Dianne?
Meeting Objective and Overview
DIANNE RAUSCH: Thanks very much Bill. As he said, I am Dianne Rausch, the Director of the NIH Division of AIDS Research. We are really pleased to co-sponsor this meeting with the NIH OAR. This meeting originated with discussions between Maureen Goodenow, the Previous Director of the Office of AIDS Research, and myself, nearly two years ago, where we were reflecting on what pharmacies and pharmacists had accomplished during the COVID pandemic, and asked what more they might do in HIV. As we consulted with others we found uniform enthusiasm for the topic as well as a growing start of activities and coalitions. As a result, we believe this meeting will be very timely.
So the formal objectives of our meeting are to convene a multisectoral group of researchers, pharmacists, community members, and federal partners, to survey the current landscape and evidence base for pharmacy centered HIV testing, prevention, and care, and identify future research directions that could advance these fronts.
We will also consider how pharmacy centered approaches could further research health disparities in populations, address HIV related comorbidities, leverage HIV trainings for pharmacists and pharmacy students, and even facilitate HIV clinical research.
Our meeting agenda will be composed of virtual panels over the next two afternoons. Today’s opening plenary features many high-level speakers who will describe where we currently stand in pharmacy and pharmacist centered work in HIV. Then the next two panels will address complementary contributions of independent and chain pharmacies, and how pharmacies are positioned to support HIV testing. Tomorrow’s agenda opens with a session on pharmacy-based efforts to support HIV prep access and delivery. It will be followed by panels on HIV treatment and HIV syndemics and comorbidities. And we will conclude with a rapporteur session that will highlight important directions for future research.
As we move through this agenda we will have some live polls to get your feedback, and we will also take some short breaks. You can find the detailed meeting agenda on the meeting website along with the bios for all of our speakers who will only be introduced briefly due to time considerations.
So let me close by thanking the NIH Working Group on Pharmacies and HIV. The planning group includes representatives of 10 NIH institutes, centers, and offices, which shows the deep breadth of NIH interest in pharmacy based approached in HIV. I congratulate our planning group in assembling an outstanding meeting agenda. So let’s get started, and let me now pass on to Dr. Paul Gaist from the NIH Office of AIDS Research, who will lead our opening plenary. Thank you.
Opening Plenary Comment
Introduction of Opening Panel
PAUL GAIST: Thank you, Dr. Rausch. And thank you to you and Dr. Kapogiannis for getting us rolling. For the first section actually if you put the speaker slide up that would be helpful. We are very fortunate to have an outstanding panel to further frame and comment on the opportunities and challenges we have before us.
As you can see here, we will start with Dr. Michael Hogue, CEO of the American Pharmacists Association. We will have prepared remarks from Harold Phillips from the White House. Rear Admiral Kelly Batiste from the US Public Health Service, Steve Massey from the US Business Coalition to End HIV Health Action Alliance. Natalie Crawford from Emory University. Katrina Ortblad from the Fred Hutchison Cancer Center, Paul Weidle from the CDC Division of HIV Prevention.
If you want further information about their background, we again remind you to go to the conference website, where there is a speaker bio directorate. So let’s start with Dr. Hogue from the American Pharmacists Association.
Pharmacists: Advancing Public Health
MICHAEL HOGUE: Thank you so much, Dr. Gaist. I appreciate the introduction, and I appreciate being able to be with you all today for this really important conversation. The American Pharmacists Association is the voice of pharmacy across the profession regardless of practice setting. We represent approximately 330,000 pharmacists, 49,000 pharmacy students, over 400,000 pharmacy technicians, and 30,000 pharmaceutical scientists who are working every day to make lives better for the patients that we serve.
Pharmacists are experts trained to optimize medications and improve health. Many of us think about pharmacists and we think about perhaps the traditional role of pharmacists making medicines and dispensing pharmaceuticals to patients.
And certainly pharmacists still do those roles. But we shifted as a profession from making medicines to making medicines work. We’re the third largest healthcare profession, second most in training years, behind physicians, and pharmacists are very highly accessible, with community pharmacies being within five miles of over 95 percent of our US population.
Pharmacists work in literally every practice setting, as is seen here on the slide, and are found throughout the healthcare system as integral components to the public health infrastructure in our country.
So if we go to the next slide, we will also see that the pharmacist scope of practice in the states has been utilized to expand and to meet health equity needs in local communities. Of course, many of us are familiar with the role of the pharmacist in immunizations and public health. Pharmacists have been working at the state level to improve access to naloxone, to provide tobacco cessation, and hormonal contraceptives, ease of access to HIV PEP and PrEP, which is our topic today, is really the latest area where pharmacists are stepping up to meet public health needs.
We also have pharmacists actively engaged throughout the healthcare system, from acute care to outpatient care and long-term care in terms of disease management, med management, med administration, and testing and treating for acute illnesses in communities that may have a lack of access to healthcare resources.
Pharmacists are working very closely with other healthcare providers to refer patients who may need more complex therapy or more complex intervention than can be provided by the pharmacist, and are also doing assessments of social determinants of health, all very important roles in the public health landscape.
I would just couch today’s conversation, as we think about what pharmacists can do, in terms of HIV and ending the HIV epidemic, the illustration that appeared recently in JAPhA of the role of pharmacists, quantifying the role of pharmacists in vaccines during the public health emergency. Pharmacists administered over 270 million vaccinations within community pharmacies alone, and we provide over 50 million doses of influenza and other vaccines every year, year-in and year-out.
And of course, as many of you may remember, community pharmacies, we’re the sole site for COVID testing very early on during the pandemic. This just gives us an example of how when we partner with pharmacies and pharmacists in our public health programing there can be a major impact made on the outcomes of public health. And this is just an excellent opportunity.
As we go to the next slide, it has already been referenced that the nation has an HIV/AIDS strategy for 2022 through 2025 that speaks specifically to the role of the pharmacist in HIV prevention and care, and APHA and America’s pharmacists stand prepared, ready, and willing to participate in this effort.
As we go to the next slide we will see, and we have new data actually that’s breaking news because we now have 15 states that have authorized pharmacists to prescribe PEP and PrEP therapy. Most commonly this is for a 60-day supply of initial medication through local pharmacies. This authority is tied back to statewide protocols, standing orders, and independent prescriptive authority within the states.
The State of California as an example has a current cleanup bill that is before the legislature that will allow pharmacists to prescribe for beyond 60 days to a 90 day, because of a lack of access to care in certain communities.
There are another 11 states that have active legislation to allow pharmacists to initiate therapy for PEP and PrEP, and we believe that this is following the same path that pharmacists were authorized for immunizations in meeting a public health demand.
Now, one of the things that I as the CEO of APhA want to speak about is what is on the next slide, and that is payment for pharmacists’ services in the states. This is really critical if we are to maximize and leverage the ability of pharmacists in local communities to bring an end to the HIV epidemic.
Pharmacists’ services through pharmacies have typically not been compensated through major medical benefits or health plans. Oftentimes pharmacists are relegated to the pharmacist benefit management company or PBM.
However, PBMs have a responsibility only to cover the drugs themselves, and does not provide coverage for the healthcare services that a pharmacist provides. So it will be critical as we move forward to advocate with health plans that pharmacists be added as providers under private health insurance plans as well as under the Federal Government.
Currently, pharmacists are the only state licensed healthcare providers in the United States not recognized for payment for services as a part of the Medicare program as a part of the Social Security Act. Let me say that again, because it cannot be emphasized too strongly: Currently pharmacists are the only state licensed healthcare providers not recognized for payment for services.
This is inexcusable. Federal payment and recognition of pharmacists as providers of care under the Social Security Act is essential if we want to eliminate health disparities and see success in payment in ending the HIV epidemic and getting pharmacists to take on these responsibilities within their services.
Now, I want to just commend all of the pharmacists, pharmacy organizations, academic institutions, who will be presenting through today and tomorrow’s program on the innovations that they have achieved in ending HIV through the utilization of pharmacists and pharmacies to increase access to care. We are commending you on that. And the American Pharmacists Association stands behind each of you as you move our profession forward. Thank you today for inviting us, and we will go to the next slide. It is now my pleasure to introduce Mr. Harold Phillips, the White House Director of National AIDS Policy Office. Harold, the floor is yours.
The Role of Pharmacists in the US National HIV/AIDS Strategy
HAROLD PHILLIPS: Hi. I would like to begin by saying thank you to partners at NIH for planning this meeting dedicated to pharmacy-centered HIV research and the way forward for this scientific area.
This is an issue of national importance, and events such as this catalyze efforts to support the scaleup of HIV services through pharmacies. We know that to end the HIV epidemic in the US we need to get services, programs, and other resources to the communities who need them most, many of which have been marginalized, and consequently face barriers to accessing HIV prevention, treatment, and care.
As outlined in our National HIV/AIDS Strategy, these priority populations include gay, bisexual, and other men who have sex with men, especially men of color belonging to these communities. Black women, transgender women, youth, and people who inject drugs. We must use innovative ways to reach communities by bringing much needed services, programs, and other approaches to them, as one way to reduce systemic barriers to HIV services and programs.
Pharmacists are essential to the public health infrastructure of the nation. You all have played a critical role in the response to multiple public health crises, particularly during the COVID-19 emergency. Pharmacists also have the most extensive access to local communities of any healthcare provider.
And although only about 45 percent of Americans live within easy access of primary healthcare, nearly nine in ten live within five miles of a community pharmacy. Pharmacies serve as an avenue to accomplish our goals for the National HIV/AIDS Strategy, and better the health of our nation.
Throughout the NHAS, and particularly my team, referred to the Mighty Box Six that highlights pharmacists role in meeting domestic HIV goals. Pharmacists have the potential to play a pivotal role in identifying and engaging and reengaging people with HIV who are not in care or not virally suppressed.
Increasing knowledge of HIV status through broadened testing, and expanding access to HIV prevention and harm reduction services, including PrEP and PEP, especially for people who face difficulties using these effective medications.
This past year we have seen an expansion in the provision of HIV PrEP through pharmacists. We know that only 26 percent of the 1.2 million people eligible for PrEP in the US were prescribed the medication in 2020. Many of the priority populations mentioned are left out of the 26 percent of people accessing PrEP. And unfortunately, these priority populations are not experiencing the benefits of this form of HIV prevention, and we must do something about this.
Since my time at HHS, as Chief Operating Officer of EHE, and now as the Director of the White House Office of National AIDS Policy, I have seen a great opportunity to leverage pharmacists in our work. Pharmacists have stepped up during the public health emergencies of COVID and Mpox to show us how they can play a bigger role in responding to the HIV epidemic.
I continue to work with our Office of Infectious Disease and HIV/AIDS Policy, or OIDP’s Pharmacy Lead at OASH to explore opportunities for an expanded role of the pharmacy workforce, to address not only HIV but also related syndemics like STIs, viral hepatitis, substance use, and mental health disorders as well. Pharmacies are well situated to address these needs, and there are activities underway in this area that reflect national HIV priorities involving pharmacists. Organizations and companies participating in these endeavors are working collaboratively and independently.
Launched on World AIDS Day last year in September, the US Business Action to End HIV is a coalition of private sector organizations committed to helping accelerate progress toward ending HIV in the US by 2030.
This coalition was created through a partnership between the Health Action Alliance, ViiV Healthcare, and other emerging collaborators. Several of the partners in this coalition are pharmacies, such as Avita, CVS Health, Walgreens, and Walmart. Their involvement in this coalition represents their willingness to do their part to address HIV in this country.
Just earlier this month the coalition was part of a roundtable discussion with pharmacy leaders and others on the role of community pharmacies in HIV prevention and care. Convening partners of this roundtable discussion were the White House Office of National AIDS Policy, the US Business Action to End HIV Coalition, the Elton John AIDS Foundation, and the American Pharmacists Association.
Another effort in this space includes work from our partners at the Elton Johns AIDS Foundation, and Walmart. Together they have worked to open HIV focused specialty pharmacies, and develop a national pharmacy training program to help pharmacists better meet communities’ HIV needs.
All partners mentioned and others in this space have been working with various state legislators to expand scope of practice for pharmacists, to engage in service delivery for HIV and often co-occurring conditions. Part of the process of using pharmacies as an avenue to expand HIV services is figuring out how exactly to do this in the most effective way that is tailored to community needs.
And this is where research is integral. Pharmacy centered research is key and foundational to understanding how to further develop, implement, and scale up integrated HIV approaches through pharmacies.
Research and data needs include analysis on cost effectiveness of engaging pharmacists in this work, efficacy studies on models of HIV prevention and care through pharmacies. Implementation strategies, to effectively deliver HIV prevention and care services through pharmacies. And comprehensive reviews for comparative studies of models of HIV prevention through pharmacies in various states.
NIH supported research centered on these areas and others is necessary, and closely aligned with national efforts taking place. What better time than now to hold this virtual meeting? So lastly, I am also reminded by my team of the Oath of a Pharmacist, to devote a lifetime of service to embrace and advocate for changes that improve patient care. And I want to thank the pharmacists for doing just that for our HIV community. Thank you.
PAUL GAIST: We will go to our next speaker, Rear Admiral Kelly Battese from the US Public Health Service. He is the Chief Professional Officer for Pharmacy.
The US EHE Pharmacist Task Force
KELLY BATTESE: Good morning. Thank you Dr. Gaist for the introduction, and really it is a privilege to be part of this meeting. What incredible presentations we have already heard today. And so, it is a privilege to be a part of it. I’m going to give a little bit of an update on the United States Public Health Service going forward. So, no disclosures or conflicts to report.
What I really want to talk about today is how we partner with pharmacists, and even pharmacy technicians, to advance HIV prevention and care nationwide. So we really want to speak a little bit about the Public Health Service Pharmacy Program, who we are, the state of affairs, officer engagement, and really talk about our Ending the HIV Epidemic Pharmacy Task Force.
The United States Public Health Service Commissioned Corps. We’re one of eight uniformed services. We are led by the Assistant Secretary for Health, Admiral Levine and our United States Surgeon General, Vice Admiral Murthy.
Our mission is to protect, promote, and advance the health and safety of our nation. What an incredible mission that is, what a privilege it is to serve in the United States Public Health Service Commissioned Corps. And we do that through leadership with integrity, through service mindedness, and we try to do everything with excellence. Those are our core values, those are how we try to meet that mission.
So as we talk about specifically the pharmacists, the pharmacy officers in the Public Health Service, we currently have a little over 1260 active-duty pharmacists, really across the country and even across the world. They are stationed in 12 different federal agencies currently. You can see the list there, to include the CDC and the Bureau of Prisons, the FDA, the Indian Health Service, as well as NIH, who again I am thankful who is hosting this meeting today.
So, a little bit about current affairs, both at the state and federal level. We know at the state level that the scope of pharmacy practice varies greatly based on the state. We have some states who are well advanced, and some that are not.
And really looking at pharmacist led care delivery, collaborative practice agreements, working through standing orders, and really when it comes down to state specific laws we need to work with those boards of pharmacies and the states. A couple of shy examples, really North Carolina and New Mexico that really have advanced practice models for their pharmacists.
From the federal perspective, as already has been mentioned well today, the COVID-19 PHE really highlighted what we already knew, that our pharmacists have incredible skill and an incredible value. As we talk about test-to-treat, that was a huge, shining example of the skillsets and values.
And I want to highlight a few of our federal agencies that are leading the way in advanced scopes of practice, especially in that clinical practice model. And those are the Indian Health Service, the Immigration and Custom Health Service Corps, and our Bureau of Prisons.
So the Federal Pharmacist Practice. Here is a little bit of comparison between these three agencies, all very advanced, really looking at the PrEP prescribing protocol Indian Health Service and Bureau of Prisons have implemented and are doing and doing well, and I know our ICE Health Service Corps is working on that.
They are involved nationally presenting, they’re doing disease state specific consulting, and we are credentialing them on just this incredible skill set, incredible clinical practice that they have across multi disease states, and we’re highlighting that work with this national clinical pharmacist specialist credential.
So I really want to talk about the pharmacy and the Ending the HIV Epidemic Task Force. I’m really proud of this group and the work that they’re doing. The mission is great, it’s a force-multiplier really to end the HIV epidemic.
Our goal is really to support pharmacists in opportunities to expand their role. We know their skillset, we know their accessibility, we know we need to expand that, and they can do more. We want to ensure health equity by sharing best practices and supporting innovation across the country. And really prioritize activities that support EHE strategies. We talk about diagnosing and treating, preventing, and also responding.
So our objectives are to optimize clinical and community services within the organizations to improve HIV-related outcomes. And really create a resource repository for best practices that can be shared and used across the country, really with strategic outreach to local, state, and national resources for education, education opportunities, and really looking to partner with our allies. We have many allies across the country, and one of our focuses is really partnering with pharmacy schools so that we can start training our pharmacy students that they come out of school ready to engage with this.
So, a couple of our activities and accomplishments. Speaking of the coordinated response, we come together monthly to convene and advance our HIV response, and we do that by sharing our successes so that we can gain from one another and learn from one another and take those shared responses back and implement them and be more effective.
We are looking to build partnerships. We have already heard about that, how critical it is to build partnerships, to leverage national associations. I’m so grateful for Dr. Hogue’s involvement today.
To really understand the pulse on current gaps in HIV services delivery, and really connect those local, state, and federal resources and tools for pharmacists across our nation. Currently our task force is actively contributing to the National HIV Certificate, which is being developed by the American Pharmacist Association, and we are really looking to engage with state boards of pharmacy, really for continued education credits nationwide for our pharmacists.
So really, how do we engage, and points of contact. So I would like to say now is the time. We want to continue this momentum, this positive momentum. We’ve seen pharmacists serving as public health leaders. Pharmacists are leading the way in public health. They are vital partners in addressing equity and serving underserved communities, and Dr. Hogue gave some data that supports that. All across the country we are accessible, we are there, we are skilled, we are ready. So we need to capitalize on that. In a couple calls to action is really to help address gaps in pharmacy delivered HIV care.
Now, I can’t say more than Dr. Hogue said on the reimbursement model, but that needs to be addressed, and I know that they are working on that. We need to keep working on scope of practice issues. We need to advance our practice across the country, state by state. And really work on workflow integration so that our pharmacists have the skillsets, have the time, have the support to do this important work.
I would also like to highlight our task force leadership, CAPT Rodriguez, LCDR Gazarian, and CDR Madrigal who do incredible jobs leading this group, and I know you’ll hear from LCDR Gazarian and CAPT Weidle later, so I’m really proud of our public health services pharmacists, how they’re leading in public health and how they’re leading to end the HIV epidemic.
I would just like to close by saying thank you. I am privileged to be here today and present at an incredible meeting, I am really excited to see what comes of this, and I really appreciate the support. So now I would like to turn it over to Steve Massey with the US Business Coalition to End HIV Health Action Alliance. Steve?
Building a Coalition of Pharmacies to Respond to HIV
STEVE MASSEY: Thank you so much. It is really a pleasure to be here. I am also just really grateful that you’ve included the US Business Action to End HIV Coalition in this important meeting. My name is Stephen Massey, I’m the cofounder of Meteorite, which is an impact agency that builds coalitions with the business community to tackle some of society’s biggest challenges.
Meteorite helped establish the Health Action Alliance in 2021 in response to the COVID-19 pandemic, to help employers engage their workforce with information related to COVID testing, vaccines, and ways to create healthier workplaces and stronger communities. HAA was created by the Ad Council, the Business Roundtable, the CDC Foundation, the de Beaumont Foundation, and the Robert Wood Johnson Foundation, to serve as a bridge between business and public health, and identify areas where these two sectors can find common ground and work together.
Today we work with a network of over 7000 companies from all 50 states and Puerto Rico who rely on our free programming to help them navigate evolving health challenges and make their workplaces healthier and their communities stronger.
As I mentioned a moment ago, HAA started with COVID-19, but we have significantly expanded our focus to help employers address other health issues, including workplace mental health and navigating the health impacts of climate change.
At HAA we know that good health is good business, and that employers are an integral part of our public health infrastructure. In fact, the most recent Edelman Trust Barometer underscores the high level of trust that Americans have in the business community to deliver health information and support healthy outcomes. In fact, business are seen as more trusted and more effective at improving health than just about every other sector. Which is why we believe that employers are a critical part of ending the HIV epidemic in the US.
In 2021, I was invited by PACHA to talk about the potential role of the private sector in our national HIV response. Our nation as everyone knows in this meeting has created a bold vision to end HIV by the end of the decade. But we believe that in order to get there we will need everyone at the table. A few months after that presentation, Viiv Healthcare reached out to us and said that they believed in that vision, and wanted to provide seed funding to see if a US business coalition on HIV was a viable initiative.
After several months of conversation with HIV experts and companies across the country, we were proud to have launched the US Business Action to End HIV Coalition late last year. This coalition was announced on December 1st at a White House Commemoration of World AIDS Day, with leaders from the federal government, public health, and representatives from 15 founding member companies of the coalition, including leaders in the pharma industry like Avita, CVS Health, Walgreens, and Walmart.
The goal of this coalition is to help accelerate progress to help end HIV in the US by 2030, aligning with the National HIV/AIDS strategy, and improving health equity in underserved communities across the country. This coalition is being developed in partnership with the National LGBT Chamber of Commerce and with additional funding support from Gilead Sciences and Viiv Healthcare.
Now, this coalition represents a growing group of companies, with representation across industries, not just pharmacies, prioritizing large employers with reach in those communities disproportionately impacted by HIV in the US. When we created this coalition, one of the opportunities we saw was the potential to bring together companies from within the same industry who could have the unique impact on ending HIV. To think collectively about the challenges and opportunities that companies in the specific industry face, to get out of our typical silos and see what could be possible if we work together, learn from one another, and even coordinate. We see potential to create shared momentum and exponentially improve our impact that could lift up a whole industry.
We’ve been calling this concept Industry Action Cohorts. The idea to create collective action within a single industry. Given the large number of pharmacies in our coalition, and all of the work that is being done across those industries, to think about how community pharmacists and pharmacies can help close gaps in HIV service delivery, we chose our first industry action cohort to be focused on the pharmacy sector. As Harold Phillips mentioned a moment ago, we convened a meeting with the White House Office of National AIDS Policy and the Elton John AIDS Foundation, together with the American Pharmacists Association earlier this month, to explore the role of community pharmacies in expanding access to HIV prevention and care. We believe that pharmacists are an essential part of our public health infrastructure, and can play a vital role in accelerating our country’s progress toward ending HIV. At that meeting, held just three weeks ago, we had representatives from major retail pharmacies and community pharmacies, professional associations, advocacy groups, and members of the Federal Government and experts who have been working deeply on these issues for many years, including some of the folks who are presenting at today’s meeting.
We were excited to bring together this shared brain trust, and see what happens when this group with their various perspectives could examine the challenges and opportunities in expanding the role of community pharmacies in HIV prevention and care.
We were pleased to explore our various pathways forward that would enable industry-wide action and potentially transform the delivery of HIV services that would dramatically expand access to care in the communities that need it the most.
The objectives of the meeting were to share information on how community pharmacies can impact health equity and increase access to care, identify opportunities for community pharmacies to improve access, develop a common vision on a feasible and impactful strategy, and identify a coordinated action plan for expanding the role of pharmacists in HIV prevention and care.
Now, during that meeting there was a lot of discussion about the why. Why it is so important to explore an expanded role for pharmacists in providing HIV services.
One of the most powerful things we heard was from Dr. Natalie Crawford, who will be speaking next, where she will make the strong case about why pharmacists can significantly scale up access to HIV prevention, care, and delivery, in communities hard hit by HIV.
We all see the value of pharmacy care during COVID, and now that is a proven model. We believe it is time to build on that model and adapt many of the things that we’ve learned during COVID for HIV.
At a recent meeting, participants also flagged some of the key challenges to advancing this work, including of course scope of practice, reimbursement, implementation, burnout among pharmacists, particularly post COVID, creating scalable systems for smaller community pharmacies, and creating linkage to care systems for patients, community-based organizations and other providers.
The bulk of our time was spent exploring opportunities, building on the commitment that many community pharmacies have already made to addressing HIV, like developing nationwide HIV training for pharmacists, including Walmart with Duke University and the Elton John AIDS Foundation.
We also talked about ways that pharmacists can scale up partnering with HIV organizations to provide HIV testing, as Walgreens has done for more than 13 years, including, as Walgreens did yesterday on National HIV Testing Day, where over 440 Walgreens nationwide offered free HIV testing. Pharmacies today can also combat stigma through public education or open HIV focused specialty pharmacists that meet the unique needs of this population.
We discussed reframing HIV differently, together with other chronic diseases. And I think the thing that the group was mostly excited about the engagement throughout the meeting and willingness of those in the room to work together on a shared vision for how we move this work forward, including how we might align on a state-by-state scope of policy, practice, strategy, explore federal policy opportunities and administrative designation pathways.
A summary of the meeting and action plan is currently being drafted for consideration by the group, and we will be continuing to work with these organizations as this work moves forward. We also are considering future convenings with supporting industries. We welcome the opportunity to work with anyone attending today’s meeting who would like to learn more. We are certainly excited to be part of this meeting today and explore how research can inform this work even further.
In closing, I just want to say thank you to NIMH from the NIH Office of AIDS Research, again for having me here today to share more about the Health Action Alliance and our work to mobilize businesses to help end HIV. If you have any questions or would like to reach out, you can reach me at email@example.com. And now I am pleased to introduce my good friend, Dr. Natalie Crawford from Emory University. Natalie, over to you.
The US Evidence Base for Pharmacy-Delivered HIV Services over the HIV Prevention and Care Continua
NATALIE CRAWFORD: Thank you so much, Stephen. I am so excited to present to you today on what we know about pharmacy-based services across the HIV prevention and care continuum. I want to acknowledge and thank my esteemed NIH colleagues for coordinating this timely and important meeting.
Before I start, I also want to highlight that while I’m going to speak to you about pharmacies, I’m trained as a social epidemiologist, not a pharmacist. So what I’m presenting to you today is meant to elevate the skills and experiences that I have learned about from pharmacists through a public health lens as it relates to HIV.
Pharmacists have a unique and irreplaceable expertise in their professions. So I see this work as interdisciplinary and requiring the expertise of pharmacists, behavioral, and implementation scientists, physicians, and importantly the community.
As an anchor to my presentation I want to highlight, as Stephen noted, the why pharmacists question, as we are here in this longstanding battle to end the HIV epidemic.
So many of us have been working in HIV prevention and treatment, and know that the thorn in our sides, despite having amazing behavioral and biomedical interventions, is that racial inequities in HIV are pervasive.
Counterintuitively, we have not been able to explain these inequities away with increased risk behaviors nor lower health promoting behaviors among racially minoritized populations. And so today we are grappling with why these inequities persist and what to do about them.
One of the answers, but by no means the only answer, is that the resources that we need to reach people, such a PrEP, to prevent HIV transmission, are failing to do so. I want to depict this with you visually with just one small example. This map shows the HIV incidence in the Ending the HIV Epidemic areas in Atlanta, Georgia. The darker red represents higher cases. And as you can see in the southeast and southwest areas of Atlanta there is higher HIV.
These yellow triangles show where there are currently PrEP prescribing clinics. Most of these clinics are situated in the city. And there are others that are dispersed in the northern part of the metro area. But where we need it the most, in these areas in the southeast and southwest, there are complete deserts.
These are the places where we need to be able to easily access PrEP, but we currently can’t. And these differences in access are by race and SES, as the northern areas are richer and whiter and the southern areas are blacker and poorer.
We have repeated this analysis for every state in the southeast and all of the Ending the HIV Epidemic areas, and this is the exact same story. Where we need the resources the most they are mismatched, in areas where we need the resources the least.
Now, here we show where the pharmacies are. Each blue dot represents three pharmacies. Pharmacies are ubiquitously located and not distributed by race nor SES. So pharmacists could be the solution for creating equity and ending the HIV epidemic. I want to repeat that: Pharmacies could be the solution for creating equity in ending the HIV epidemic.
So what do we know about their ability to do so? This table shows the results of a systematic literature review between 2004 and 2019 of pharmacy-based studies across the HIV prevention and care continuum. Since these data have been published there have been several additional studies, as well as reviews, that have ballooned some of these numbers, but there are some notable and consistent findings across these studies.
First, all of the studies have shown that HIV prevention and care services are highly feasible, and acceptable by pharmacists, pharmacy technicians, and pharmacy clients. Notably Dr. Weidle has shown that HIV testing can be conducted within a 30-minute period, with strong cost effectiveness.
Dr. Dilworth(ph.) has shown that HIV specialized pharmacies have immense promise in increasing antiretroviral adherence, reducing viral load, as well as secondary HIV infections in the community.
And in fact, in this model, for HIV specialized pharmacies, for every dollar that we spend training pharmacy staff to enhance HIV treatment services we save three dollars. That’s a threefold savings in expenditures.
We do know less about cost effectiveness for syringe service, PEP, and PrEP. But we also know that most of these studies have effectively reached the general population, which could greatly expand the reach of biomedical interventions for individuals that are disconnected from the medical system and who also don’t realize that PrEP is indicated for them and would be a good option for them. So we should consider that we are creating another pathway to accessing healthcare resources for individuals who are isolated from the medical system.
And finally, and importantly, because of the nature of pharmacies being disease neutral, where anyone can go, we are able to reduce HIV exceptionalism and end stigma as well. in fact doctors Amesty and Lewis show that integrating HIV testing in pharmacies can reduce HIV related stigma.
I think one of the most recent estimates is that Americans visit pharmacies about 35 times a year, that’s about three times a month. And so if people are able to see HIV testing just as a normal, routine part of care, it will certainly reduce this idea that HIV is as scary as some people think it is.
And while there is mounting evidence that HIV prevention and treatment enhancements can work in a pharmacy, there is still room to grow some of the evidence. So, first, few studies have examined these services longitudinally. Those that have have shown successful deployment of harm reduction services to people who purchase syringes in pharmacies, which ultimately reduce drug use practices over an 18-month period. Most studies have also only been evaluated in a handful of pharmacies.
A notable exception to this is a recent publication by Dr. Klepser and Dr. Weidle, among 61 pharmacies who successfully integrated HIV testing and Hepatitis C testing in pharmacies.
But we still have a limited understanding of when these services are implemented if our specific risk groups will receive them well. The specific risk groups that have the highest HIV transmission. So this is particularly true for men who have sex with men and trans population.
There are some cross-sectional data from the American Men’s Internet Survey that have shown that over 70 percent of men who have sex with men want these services and are open to these services, but we need more data on when we should integrate these HIV prevention and treatment services, how they will actually be accepted in real life.
And then finally we need to test the implementation strategies that work best for integrating these services into the pharmacy workflow, on the pharmacy staff side as well as the client side. So essentially the remaining scientific evidence that we need to build rest on longevity, sustainability, and scalability. But if we know it works, why hasn’t it taken off yet?
So there are multi-level challenges that stand in the way of this really taking a hold. Although we’ve seen so much success with pharmacies in their reaction to COVID, I think the biggest challenge for HIV I would argue are federal and state level policies that would create a natural pathway for provision and reimbursement of HIV prevention and treatment activities.
And really that’s what I want to focus on today, although I would like to share this slide to highlight that there are multilevel challenges that we need to keep in mind.
So in the absence of these critically needed pharmacies that designate pharmacists as providers, we need to continue to build the implementation science evidence. Given that pharmacy scope of practice is determined on a state level, we need to make sure that we are examining each context and state specific nuances we need to develop and test strategies that can be scaled and examine their cost effectiveness.
My lab was very grateful to just be awarded an R01, establish the implementation science evidence for pharmacy-based HIV prevention in the southeast. But we also need to establish this for other regions, as well as pay attention to the specific risk populations captured and served in each setting.
Secondly, our research should be trying to test alternative pathways for integration and expansion of these HIV prevention and treatment services, such as collaborative practice agreements, and building up pharmacy staff HIV specific trainings. And this is for the pharmacist and the pharmacy staff, because techs and clerks should be considered in the workforce development, and they can reasonably provide pre- and post-test counseling and linkage to care with sufficient training.
Finally, I just want to leave you all today with the idea that we also just need to maintain our focus on why we are doing this in the first place, equity. Achieving equity is not easy. However, everyone deserves a chance to realize their full potential of their health, and I believe that this is a very strong place that we could begin to help realize that.
I want to thank you all for your time. I do want to acknowledge all of my wonderful collaborators, NIMH, for all of their support and funding in this specific area. And now I want to turn it over to my colleague, Katrina Ortblad from Fred Hutchinson Cancer Center. Thank you.
Lessons from Global Research in Pharmacy-Based HIV Service Delivery
KATRINA ORTBLAD: Thank you so much Natalie. I am Katrina Ortblad, and it is a real honor to be here today. Today I’m going to be presenting on lessons from global research and pharmacy-based HIV service delivery on behalf of the Kenya Pharm PrEP Research Team.
In Africa, HIV incidence is high, and barriers to PrEP access remain. In most African countries, PrEP, which is often a donated public commodity, is primarily being delivered in public HIV clinics. Here, client barriers to access include stigma associated with visiting these HIV clinics when not living with HIV, limit hours of clinic operation, and long wait times and travel distances to these clinics.
To help overcome barriers to clinic delivered PrEP services, differentiated models of service delivery are needed. In an era of declining PEPFAR funding, getting PrEP into private pharmacies could help leverage the private sector to sustain African countries’ HIV response. In Kenya, the Ministry of Health in its five-year PrEP scale-up plan identified pharmacies as one of several delivery points, and implementation research on pharmacy delivered PrEP services as high priority.
Private pharmacies are a promising setting for PrEP delivery for a number of reasons. First, in many low- and middle-income countries, roughly 50 percent of individuals first go to private pharmacies for their healthcare needs.
These private pharmacies are well situated to address both urgent needs, like STI treatment, and preventive care needs like blood pressure testing. It is also common that individuals in these settings purchase services here that are already offered for free at public clinics, like contraception.
Then in Kenya there are over 5000 licensed pharmacies, which you can see scattered across the country on the map on the right. And these pharmacies are overseen by a regulatory board, they have annual renewal requirements, and they also have continuing professional development requirements.
In collaboration with Dr. Elizabeth Bukusi’s team at the Kenya Medical Research Institute, and Dr. Kenneth Ngure’s team at Jomo Kenyatta University, we have been conducting implementation research related to developing and testing a model of pharmacy-delivered PrEP services in Kenya for the past five years.
This research has included formative, qualitative research, stakeholder engagement, and pilot studies that I will present today, as well as an upcoming hybrid cluster randomized control trial that will create evidence that can inform implementation and scaleup.
Back in January 2020, we developed with Kenyan stakeholders from regulatory and professional boards, a care pathway for pharmacy-delivered PrEP services that was informed by a formative qualitative research.
This care pathway was based on a model of pharmacy-delivered PrEP services ongoing in the US at the Kelly-Ross pharmacy in Seattle, which relies on a prescribing checklist to identify clients unlikely to have any medical conditions that might contraindicate PrEP safety, and dispense PrEP with remote clinician oversight.
We then tested this care pathway in two pilot studies which I will describe on the next slide. To be eligible for pilot participation pharmacies had to have a private room, have a licensed pharmacist or pharmaceutical technologist, and have a full-time provider. Eligible clients had to be over 18 years and meet the criteria on the checklist.
We recruited clients using posters, pharmacy providers recruited clients purchasing services associated with sexual and reproductive health, and then we also ended up using a lot of word of mouth referral. All commodities, including PrEP drugs and HIV tests, were donated by the Kenya Ministry of Health. Our primary outcomes were PrEP initiation and continuation, as well as a number of implementation outcomes.
Here you can see an overview of the two pilot studies we conducted. The first was conducted at four pharmacies, we delivered oral PrEP services to individuals over 18 years that met the criteria on the checklist. For HIV testing we used oral fluid HIV self-test due to some restrictions on the delivery of rapid diagnostic tests by pharmacy providers in Kenya, and we charged clients 300 Kenyan shillings for each pharmacy PrEP visit, and the study lasted for 12 months.
We then extended the study and expanded to 12 pharmacies. We additionally added PEP as well as PrEP to the delivery model, and STI testing at select pharmacies. We switched from oral fluid to blood-based testing. We dropped the dispensing fee to clients, so all services were free. And this pilot extension study lasted for six months.
And here you can see a number of the pharmacies and pharmacy providers that participated in these pilot studies. So this is pharmacy PrEP live in Kenya.
These figures here show the number of participants that we screened, found preliminarily eligible for pharmacy delivered PrEP services, and enrolled and initiated PrEP in each of the pilot studies.
In the pilot study where we charge clients a fee for PrEP services, roughly 60 percent initiation to PrEP, and when we drop this fee over 90 percent initiated PrEP. What I think was striking in both studies is that roughly 90 percent of all individuals that initiated PrEP at private pharmacies had previously never used PrEP.
When we look at the demographic characteristics of individuals initiating PrEP in these settings, you can see that roughly 50 percent were male and 50 percent were under 25 years, and three in four participants were unmarried.
Some of the most common behaviors associated with HIV risk were having a partner of unknown HIV status, which was in over 70 percent of participants having multiple sexual partners, and inconsistent condom use.
We then compared these demographic characteristics with those of clients that are being reached at public health clinics in Kenya, using data from large scaleup studies that delivered PrEP at HIV clinics, maternal and child health clinics, and family planning clinics.
And what is striking here is that the private pharmacies seem to be reaching a younger population, they seem to be reaching more unmarried clients, and they seem to be reaching more clients that have partners of unknown HIV status and multiple sexual partners, and fewer partners known to be in an established relationship with someone living with HIV.
When we look at PrEP continuation at private pharmacies, we found roughly 55 percent continuation when we delivered PrEP for a fee, and this increased to 72 percent continuation when we dropped this fee. And PrEP continuation was greatest among men over 25 years.
We also compared these PrEP Continuation rates with those that are seen at public clinics in Kenya. So in blue you can see PrEP continuation from the pharmacy studies, in purple you can see continuation from HIV clinics in Kenya.
In Solid purple at HIV clinics, and in the dashed lines are the maternal and child health clinics. And what you can see is that PrEP continuation in the private pharmacies was comparable to PrEP continuation at public clinics in Kenya, and outperformed some clinics, in particular the material and child health and family planning clinics.
And then additional analyses that will not be presented here suggest that pharmacy-delivered PrEP services are highly acceptable among clients and providers, and also low cost.
This research team is now about to win, actually we just enrolled our first participants last week, a four arm 60 pharmacy cluster randomized control trial in Kenya, which is testing different cost sharing models for pharmacy delivered PrEP services, which multiple speakers have emphasized today the importance of figuring out correct cost structures to keep this model self-sustaining.
So, in one model, in one arm, clients will pay a fee for pharmacy delivered PrEP services. In another arm, implementors will pay this fee. And in another arm this fee will be offset by an HTS counselor that will be stationed in the pharmacy to complete HIV testing, which was a time-consuming step for pharmacy providers in the pilot studies. And then our control group will be what is currently in providers’ scope of practices at the moment in Kenya, which is referral to existing clinic-based services.
So, in summary, PrEP is not having the maximal impact on HIV incidence, and it is not easily accessible to all those in need. Private pharmacies are a promising delivery channel that can help Kenya and other African countries sustain its HIV response.
There is high interest in this model from policymakers and funders, and this model is being incorporated into PrEP scaleup plans. Our pilot studies suggest that this model is feasible, in demand, reaches PrEP naïve populations with behaviors associated with HIV risk, and can achieve outcomes comparable to those with clinic delivered models of PrEP service delivery.
However, there is currently no playbook on how to operationalize the delivery of public PrEP services in private settings. So our studies are generating evidence on this model’s effectiveness and cost. We’re identifying training needs for pharmacy providers, and exploring options for procurement, quality assurance, documentation, and reporting that could help sustain this model.
And finally, Kenya is a great test case for pharmacy delivered PrEP services in Africa. If successful in Kenya this model could be adapted for other countries and repurposed for other interventions, like long acting cabotegravir antiretroviral treatment and combination prevention interventions.
And I just really want to thank all of my colleagues that I’ve worked with on this research. The Pharm PrEP research team, many of whom you can see listed here, as well as stakeholders that have informed this research, and our funding sources from the NIH and Bill and Melinda Gates Foundation. Thank you. And now I would like to pass it off to Paul Weidle at the CDC Division of HIV Prevention.
Discussant Comment: Building on Our Accomplishments with Next Steps
PAUL WEIDLE: Thank you Katrina. That was a terrific presentation. So I work in CDC’s Division of HIV Prevention as a Senior Advisor for Ending the HIV Epidemic Strategies. I don’t have any slides, I just have a few comments here that will lead into the question-and-answer period.
When considering the current landscape and future frontiers to pharmacy centered HIV research, approach pharmacists as your public health and clinical partners. When you’re thinking about programs to design, design them with them, not for them.
You will find that pharmacies and pharmacists are very diverse. Some pharmacists may be extensively trained in infectious diseases and HIV, like those that work in HIV clinics all around the United States, but they may work in community pharmacies and have gone through the extra effort to develop their staff to serve persons from populations that are disproportionately affected by HIV.
Some of these pharmacists may be certified by the American Academy of HIV Medicine as HIV pharmacists, so you instantly know their credentials. Other pharmacists you will want to partner with may be generalists and may not be HIV specialists, but have knowledge of their community that can be leveraged through populations of interest.
Large retail chain pharmacies have extensive reach and can implement programs over a wide area. The approach to program development may need to be more standardized than not, with training that may be repeated as new staff are hired or staff are moved between stores.
Independent pharmacies may have one store, or maybe many stores in a geographic area within a state or across state lines. These pharmacies will typically be locally owned and owner operated, and pharmacists in these places are more likely to be generalists serving clientele with a variety of chronic and acute health conditions, and HIV may not be their top seller.
In rural areas, the pharmacists and technicians working in chain or independent pharmacies lived in those communities and know firsthand the challenges people face. These pharmacies can be great places to partner with a local health department and with community health workers.
And it is important to consider any programs you may want to implement with pharmacies, whether it will be available any time or just during specific days or hours, or by appointment. Walking into a pharmacy to buy syringes would be an example of an any-time service.
More than 25 percent of persons who inject drugs obtain sterile syringes from pharmacies. And most states that allow for non-prescription syringe sales to people who inject drugs, some states have programs that provide a framework to work within.
However, implementation is typically left to the discretion of the pharmacist on duty. So education and support for pharmacy staff are needed for consistent application when nonprescription syringe sales in practice so pharmacists feel they are part of the solution to the prevention of infectious disease transmission, and not part of the problem of illicit drug use.
Coming in for PEP would also be an any-time, on-demand type of service, and perhaps you would have to have an on-call component for after-hours. PEP is expensive, so there needs to be a structure in place to cover uninsured or underinsured persons in real-time.
Coming in to be evaluated for PrEP would typically be by appointment. We hear a lot about PrEP in pharmacies during this meeting. I think as the case has already been made, pharmacies are businesses, and any serious program we wish to implement with them has to be able to make a business case.
Pharmacists’ time is expensive. They typically make less than doctors, but more than nurse practitioners, physicians, assistants, and nurses. However, there are also pharmacy residents in some ambulatory community pharmacy settings. These recent graduates will generally have protected time to develop new programs and services.
And the last thing I just want to say is retail clinics are often collocated in pharmacies. Some of these are owned by the parent pharmacy organization, while others are used as a space lease by the local health system.
In either case, administratively, retail clinics are separate business structures from the pharmacy, with their own management and staffing, typically nurse practitioners or physicians’ assistants. So retail clinics are providing many services that support HIV prevention, PEP, PrEP, as well as STI management, collocated in pharmacy services. So with that, let me stop and turn it over to Paul Gaist to get us to the question-and-answer period.
Questions for Opening Panel
PAUL GAIST: I will ask for the panel members to please all turn your cameras on, so that we can have a bit of a discussion and to answer questions that we are receiving. I’m hesitating because I was going to jump in with my question, but I will put myself to the back. One interesting question that came up, that I will make a comment on, is what specifically is the substance use disorder harm reduction protocol? Can you be specific?
And I think, if I may, that was referring to Harold Phillip’s remarks, and unfortunately he is not with us live. But I do not think he was referring in his remarks to a specific protocol, I think I will open up to the panelists if they want to make a comment, but in general, in terms of the intersection of harm reduction, philosophy, and services, and the pharmacy space, there is a lot of discussion that has been taking place, that a lot of things are happening essentially in terms of making services available and accessible.
People talk about the syringe services programs, but there’s ASA with the opioid crisis and a number of other challenges that we’re facing, the harm reduction model and the services that come with that does lend itself to discussions within the pharmacy space. I am just not prepared to talk about a specific protocol I’m not aware of. But I would ask the panelists if they have some additional insights to that.
MICHAEL HOGUE: This is Michael Hogue from APhA. I’ll just comment that there’s not just a set arrangement, or a way to deal with or to handle substance use disorders. We are seeing across the country pharmacists in various aspects of the health system, in some cases embedded with physicians in medical practices, and in some cases in community-based pharmacies that are getting very involved in addressing the opioid crisis through the use of the medications that are available, and of course just screening and doing community-based screening.
And so there is quite a bit of that that is taking place across the country. And as Harold mentioned in his remarks there are so many of the things that we do in public health and outreach to our communities that are coupled together. So when we have access in local communities with pharmacies and pharmacists, we need to capitalize on that access to be able to get pharmacists engaged with their patients.
The key thing here is the public health infrastructure. I think if the pandemic illuminated anything it illuminated to us that pharmacies are vital to the public health infrastructure in our country, and the access to pharmacists from rural communities all the way to inner city areas as Natalie mentioned is very important.
And so there is not a standard, specific protocol as I think the person who asked the question was referring to for screening and treatment of substance use disorders, but I can tell you that pharmacists are increasingly getting involved in that, have been involved in it, and we anticipate will have a key role to play in our health system.
PAUL GAIST: Thank you for that. We are certainly seeing that there are opportunities in terms of, now that we have actual countermedications about education and overdose, counseling, health education, referring people to treatment as may be appropriate, there really is a lot of opportunity I believe in this space. We can move to the next question unless there is anyone else wanting to make a comment on this.
NATALIE CRAWFORD: I am happy to add to that. I do want to just note that there are a number of states that have passed legislation to deregulate syringe sales. New York State was one of the first, there are also a number of states that allow over the counter naloxone distribution.
And on the research side, I think Dr. Louis will talk about this tomorrow, there have been a number of actually randomized tests of how pharmacists can be trained in harm reduction principles to deliver those services, and whether those enhanced services can reduce risk behavior.
And so that was one of the things I was referring to in my presentation, where that work has shown that pharmacists who are trained in harm reduction principles can effectively have a trickle-down effect on their clients who purchase syringes without a prescription, and that will reduce syringe sharing, receptive syringe sharing, and increase utilization of pharmacies as their primary syringe source. And so I agree with both Michael and Paul in that pharmacies do have a really significant role, and can have an even bigger role in helping to address the needs of people who use drugs in the current opioid epidemic.
PAUL GAIST: Thank you. Any other comments on this? I want to move to the next question.
MICHAEL HOGUE: I just want to add, because the issue of buprenorphine of course comes up regularly, I just did a quick check of our state leg folks, and I am told that there are 11 states that allow pharmacists to prescribe medication assisted treatment through either independent prescriptive authority, state protocol, or collaborative practice agreement which improves harm reduction strategies through the use of buprenorphine. So I just will mention that that is following closely behind pharmacists’ authorization to furnish HIV PEP and PrEP therapy. Slightly fewer states, 15 for HIV PEP and PrEP, 11 for buprenorphine.
PAUL GAIST: Thank you. And there is also the opportunity that is I believe increasing through telehealth as well, of the availability. And to get to part of Natalie’s comment, and the comment to the panel, there is also community and health distribution disparities with regard to getting that type of medication that’s needed. So I think that once again the geolocation of a pharmacy, the reach of telehealth, really needs to take into account the equity and the disparity equation.
That leads us to our next question, which is any EHE, Ending the HIV Epidemic, any EHE counties and specifically the EHE pharmacy task force is working with, and what is their role in the relationship, any support with data care efforts in those EHE counties?
PAUL WEIDLE: I will go ahead and answer that question. I think Admiral Battese had to sign off. It might have been a misinterpretation. So the EHE Pharmacy Task Force is a group of different federal agencies that really are trying to support, we don’t work directly in any counties, we don’t have any funding or anything like that.
We work really to support OIDP, Office of Infectious Diseases AIDS Policy, you can think of it as extenders, we try to be a group that can support these kinds of efforts, OIDP from different agencies. So we don’t have any projects that we’re doing in particular counties. We are working on a PrEP and PEP CE program with APHA, but that is kind of like an effort with them. So thank you.
PAUL GAIST: Thank you. Any other comments on that? And Dr. Weidle, if it is okay, I think I had forecast this, I am going to put the ask for the URL to the paper with Donna McCree that you coauthored, and a number of other people, which I think is a good overview related to EHE. Is that right? I just sent that to Janelle.
Our next question is, I am going to jump to, PrEP persistence, I think this may be Katrina, I am not sure if it is specifically for you. PrEP persistence depends on timely refills. Do pharmacy based PrEP programs facilitate timely refills, if so, how? I think it’s not just for your presentation but really for the panel overall.
KATRINA ORTBLAD: I am happy to answer what was observed in our studies. In our pilot studies, around 80 percent of participants that refill their PrEP did so on time, or sort of within the window of when they were scheduled for a refill visit.
But I think that those metrics are hard to interpret sometimes, because people’s HIV risk is constantly changing. So sometimes people might no longer need PREP, they started it, their risk changes and they no longer need it, but then all of a sudden their risk changes again, and they want to reinitiate PREP.
So I think it is also trying to understand how PREP use aligns with these periods of risk. I know that’s a continued challenge for PrEP implementation researchers in the field that we’re working on.
PAUL GAIST: Thank you. Any other comments before we move to the next question?
NATALIE CRAWFORD: I can add to that for the US context. I think one of the most robust examinations of this has been among the One Step PrEP Program by Elyse Tung, and she is going to speak soon, and her data show pretty high adherence, timely refills, and I think they were doing some additional legwork to increase timely refills among their sample, I believe adherence was upwards of 90 percent. So there are some PrEP programs where people do identify their risk perceptions are ongoing.
But I do agree with Dr. Ortblatt that risk perceptions are one of the things that I think is an issue with the field in terms of adherence, and something that is separate from what we see as PrEP being integrated in a pharmacy, that risk perception is something that we are going to have to really better understand overall in terms of keeping people onboard and on PrEP when they actually are indicated for it.
PAUL GAIST: Thank you for that. And a bit to the broader audience, a bit of a teaser. You have the agenda, so you can actually see the item. We have a bit of an insider on the content. These are great questions that you’re submitting, and actively listening as we continue through the meeting today and tomorrow, you’re going to hear through different speakers also some of these questions being revisited and answered.
I would like to go to the next question, which is given the increase in the number of tasks that a pharmacist, I think what happens is when the next question comes in it jumps my screen. The number of tasks that a pharmacist and pharmacy technician can perform, what is the status of the workforce? Are there enough pharmacists and pharmacy technicians to perform these tasks in the high quality, equitable manner? And in parentheses, I haven’t been into a pharmacy where there isn’t a line at each of the windows.
MICHAEL HOGUE: I am going to take a stab at that question. That is a question that we could probably have another conference about. It’s a big question. So, thanks for asking it. I really appreciate it.
First of all, let me just say that what you’re seeing happen right now with the community pharmacy workforce, and when I use the term community pharmacy I’m speaking very broadly about any pharmacy, whether it’s a chain or independent that’s located in a local community. So we’re talking very broadly about community pharmacy practice.
We’re in the middle of what I would consider to be a transformation of the model of practice in community-based pharmacies, because we have pharmacists in all of those practices who are very highly clinically trained individuals, and we need to be able to access their clinical knowledge to be able to improve patient care. But we’ve got a system that is setup that has largely been designed on the focus on distribution of pharmaceuticals, the drugs that we all need to be able to live and do the things that we normally do.
So what’s happening right now is that the laws and regulations that were written around pharmacy practice for decades were focused very much on the safe distribution of those products. And we do want safe distribution of those products, but those laws and regulations at the state level often did not allow for automation or the utilization maximally of pharmacy technicians for what they’re trained to do, and relied almost entirely on pharmacists to do that distributive function.
What we are working on right now at the federal level, working with the 50 states, is to try to modernize pharmacy practice legislation to allow for automation and robotics to be involved safely in the provision of the medications, therefore reducing the local pharmacy store wait times, reducing the burden of that dispensing function on the staff that are there so that we can free up the time of the pharmacist to be able to have quality experiences and quality interactions with their patients, and to be able to provide high quality care for this. We have some states where that is happening, it is happening very well and with great excellence. We have other states where there is still a lot of legislative and regulatory barriers that need to be addressed.
And then the last thing that I’ll just mention about this is that there is a severe shortage of pharmacy technicians in the United States right now. We probably have a fairly equilibrium or balanced number of pharmacists nationwide, but for pharmacy students, I’m sorry, for pharmacy technicians, there is a severe shortage.
So the profession is doing all that we can right now to try to recruit young people who might see a career pathway as a pharmacy technician, and to try to help those individuals find their path into the profession. So thanks again for that question.
PAUL GAIST: Because we have put through in the agenda international perspectives, but primarily it’s a US perspective overall, I’m going to go to this next question for Katrina again. How was the initiative study received by other healthcare professionals in Kenya? Recently the South African Health Professionals Council launched a court case against the implementation of the pharmacists-initiated management of ALR ART?
KATRINA ORTBLAD: That is a great question. I think one thing that led to the success of the work that we are doing here in Kenya is early engagement with stakeholders from the very beginning, and their buy-in on the design of the model, in coming up with solutions that could overcome some of the perceived challenges that they have with the model, and then continually working with them, presenting them the results from our research, and coming up with solutions to make this more sustainable and scalable in the future.
So a great example was when we had the stakeholder meeting in January 2020. We invited individuals from physicians organizations, and laboratory organizations, and dentistry organizations, and pharmaceutical organizations, and there was a big debate about pharmacists not being able to do rapid diagnostic testing.
So we got special permission from the Kenya Ministry of Health to allow PrEP initiation using HIV self-tests at the pharmacies for sort of initial pilot studies. And then over time we have worked in collaboration with the Kenya Ministry of Health to develop a curriculum for pharmacy providers so that they can do rapid diagnostic testing, and it’s an abbreviated training, and that’s what we plan on implementing in the randomized control trial.
So I think that it is baby steps, but it is continuing to sort of bring people onboard, show them the advantages of this model, and then work together to find solutions that are pleasing to different stakeholder groups.
PAUL GAIST: Thank you. It also speaks to whether it is international or the US that this is a process, and one that I think maybe getting to the question that I have for the panel about how research may play its best role in helping to answer some of those gaps or move that process further along. Here is a question to the panel overall: Would you touch on one of the tele PrEP concepts or programs, I think this is an interesting concept, I would like to learn more about the type of model that has been implemented.
NATALIE CRAWFORD: I think that some of these are state specific, and depending on which state the program is being implemented in. So for example, in Seattle, where OneStepPReP is, pharmacists are providers, and a person can go in, be tested for HIV, and leave with a prescription from the pharmacist on the same day. On the other hand, in Georgia, where the legislation is, I won’t be critical, but I will say not in the same place as Washington State, to put it nicely, pharmacists, the scope of practice is not nearly as robust.
And so in the model that we are testing in our pharmacies, essentially there is a self-HIV test that is performed by the pharmacy client, interpreted by the pharmacy staff, and counseling is done by the pharmacy staff, and then they are being linked with our medical director who can provide a PrEP prescription, a 30 day PrEP prescription over the phone, and linkage to care.
And so there are various models, this is going to be state by state likely, or program by program, and what works within not just the state legislation but also the pharmacy context as well.
KATRINA ORTBLAD: I will just add that we also have another pilot study that is going on in Kenya, which is testing a model of online PrEP delivery with collaboration with MYDAWA, which is one of the largest online pharmacies in Kenya.
So that is also a model that is using HIV self-testing that gets delivered to individuals’ homes, they upload, they interview with remote clinician beforehand, just to get a preliminary PrEP prescription, that then PrEP can be dispensed based on the result of their HIV self-test that gets uploaded.
PAUL GAIST: Thank you. I am going to ask this final question. And everyone else’s questions, really, panelists can see the questions, it really actually leads into this and gives some very interesting insights and ideas, so thank you to all the attendees for the points that you are making.
And I would ask the panel for your initial thoughts, because we are going to be revisiting this throughout the meeting. With a research in training lens, what do you see as key proximal challenges and opportunities, as well as more distal, often structural challenges? We’ve heard some of these in your presentations, challenges and opportunities that could benefit from focused research. And with that, if you can, please be specific about what research and/or training you would recommend to be considered.
NATALIE CRAWFORD: I am happy to start off. And I’ll just give a disclaimer, I may get excited as I’m hearing you speak Katrina, I may want to jump back in. But I think there are a lot of opportunities for us proximally. We know a lot about the feasibility of what can happen across the HIV prevention and care continuum.
But we don’t know all of the specific nuances. So there are going to be some community pharmacies that can sort of take hold of PrEP program and implement it easily, especially if they’re already providing chronic disease screenings. So we need to better understand what would a pharmacy with for example sort of no primary prevention need to really build up some HIV prevention and treatment services in their pharmacy.
And so we need to sort of understand what we can do to provide national, freely available trainings, and sort of what is the minimum that we can do to get people at least on the education side, and then to get them to be able to do pre- and post- counseling, and so we can think of this sort of as a ladder and build on this.
And I think that there are a lot of opportunities for us to be able to do this, particularly in the US, by using the CFARS, we could use these as training opportunities to house free trainings for pharmacists, pharmacy technicians, and we could create workforce development opportunities by giving CE credits to folks that do these trainings. It would take some work from our CFARS, but this is something that we do, we offer services all the time.
So I think those are sort of some of the immediate challenges. We really need to better understand the implementation science of everything, like what is our reach actually, how many people are we reaching, and overall I think it is important that we do reach the general population, but within that population I think it is really important for us to know how much of the specific risk groups that are at the highest risk of HIV transmission, how many of those people are we reaching, how many of those people are disconnected from care and prevention activities, how many of those people haven’t been recently tested.
Because I think those are important considerations for us thinking about what is the true cost effectiveness. So there has been this longstanding sort of debate about us thinking about whether or not pharmacists are encroaching on territory of the medical system.
My argument, and what I really think is that pharmacists expanding these services will actually reach people who would never go into a tertiary clinic in the first place. And so what we are actually doing is increasing the possibilities of the medical system to bring those folks into a system that they’ve long been marginalized from.
And so I think we really need to understand that reach so that we can really fully understand the cost effectiveness, because I think we’re missing a part of the story there. That is proximally. Distally, I think the ultimate goal here is for legislation to do what they should have done a long time ago, they should do this for HIV the same way they did it for COVID.
I am a staunch believer that we need to make this a blanket slate, and the way that we do that, and we don’t continue to perpetuate inequities, is by making it possible for all pharmacies to be able to be reimbursed for their services and provide these services that are not reaching certain populations. And if it were another population, this probably would have been done. And so I think ultimately that should be our ultimate goal, that is what we should be working towards.
PAUL GAIST: We have two more minutes. Other comments on that that someone would like to share?
MICHAEL HOGUE: Go ahead Dr. Weidle, you go first.
PAUL WEIDLE: I think one of the biggest areas of potential growth is looking at pharmacy claims data. So there’s a concept we call Data to Care RX, where using pharmacy claims data to identify people who stopped filling antiretroviral therapy, and the pharmacist then working with the physician of the person who stopped filing the prescriptions, and then working with the health department as needed to do an escalating series of interventions to find a person.
So it requires cooperation with the insurer and the claims processor, not just the clinicians in the health department. So there is a lot of work to be done with that, I think there is a presentation tomorrow about it, but I think that’s one.
I think another potential burgeoning idea is using pharmacists to help scale up STI service delivery. Soi t’s hard to do STI testing in a pharmacy right now, but we have to work through these things. Pharmacists in most states are allowed to give injections of medications, IM injections, and there are neuro-pharmacists that are giving for instance long acting antipsychotics to people on a regular basis.
So the number of medications that treat bacterial STIs like gonorrhea, chlamydia, and syphilis, are only a few, and some of them require an injection that requires training and organization, you can’t just walk into your pharmacist this afternoon and say I want my shot, because it takes a little bit of work. But I think that’s another area for growth.
PAUL GAIST: Michael, you have the last 30 seconds.
MICHAEL HOGUE: Just real quickly I wanted to say in the states where pharmacists have been authorized to furnish or prescribe HIV PEP and PrEP therapy, one of the things that we are seeing as a trend is the schools and colleges of pharmacies in those states are adopting the baseline training for pharmacists to be able to do the assessments, the testing, the counseling, and so forth, as a part of the core degree curriculum.
And so the pharmacy workforce is coming out, graduating with their Doctor of Pharmacy degree, prepared to be able to do this work. And that is certainly the case in California and Colorado and other states where pharmacists are doing this. So I think things are changing very rapidly in a positive direction. I am very encouraged by what I see happening in our schools and colleges.
PAUL GAIST: Thank you so much. And I would like to thank the panel for kicking us off and getting us rolling here, we’ve got a lot to talk about and to think about. And I am going to turn this over to Dr. Michael Stirratt, he has a poll question for us.
Live Poll 1: What is one word that comes to mind when you think of pharmacy-based HIV service delivery?
MICHAEL STIRRATT: Many thanks to you Paul, for leading our first panel. And to all of our outstanding panelists in our opening plenary, your talks are so appreciated, they were excellent. So before we go to a brief break, it is my pleasure to post our first meeting poll question. Because as much as we want to hear from our speakers today, we also want to hear from you, our assembled audience, who we thank for being here today.
So this is our first poll question. And you can access it in two ways, by going to Menti.com with your computer and entering the code that you see on the screen. You can also use a QR reader on your cell phone to scan that QR code, that will take you to the right place as well.
And I see that we already have the responses rolling in, which is great. Our question, what is one word that comes to mind when you think of pharmacy-based HIV service delivery, what would be the first word that comes to top of mind for you, as you think about the opportunities for us to further advance HIV service delivery through pharmacies and pharmacists?
I see that people are rolling in with their responses, thank you very much for joining. I see we now have over 50 responses, that’s great. And the Menti system will continue to process these as words roll in.
PAUL GAIST: They will continue throughout the break?
MICHAEL STIRRATT: Yes, they will. We will continue to receive responses throughout the break. But let’s take a look here ad what we have coming in. It’s so interesting. Here is this word right at the center, access, so the first word that people are thinking of with pharmacy-based service delivery is access. Right next to that we have equity, the opportunity to achieve better equity I the reach and impact of our programs. We heard Dr. Crawford speak very strongly about that today.
Also, these important words, opportunity. The opportunity to do more. And here is this word reimbursement, which we heard, Dr. Hogue oriented us in our opening session to the many challenges in this space with regard to achieving reimbursement for pharmacist delivered services, and a barrier that we do need to work on.
So as those responses continue to roll in, we’re now at over 80 responses there, and feel free to continue putting your words in. We see other words, accessible, non-stigmatizing, convenience. Common sense, there is a good, interesting one.
And also some challenges here too that accompany this work. Some points here that people are making, we see complex, barriers, and really I think on the whole it looks like some positive words really is what I see, but there are those challenges that are in there as well. We will keep our poll open, and please feel free to continue to add to your responses, we appreciate that. I think it is really compelling to see words like opportunity, access, and equity right at the center of what is top of mind for us all.
We are now going to take a five-minute break. So take a moment to rest and relax. We will be back with our next panel, which will be about addressing community needs across the spectrum of independent to chain pharmacies. We’ll be back with that in five minutes. That’s at 2:45 Eastern time. We’ll see you back in five minutes, and thank you so much.
Topic Panel One: Meeting Community Interests Across the Spectrum of Community Pharmacies – from Independent to Chain
Panel Speaker introductions
NELLY GAZARIAN: Thank you all for being here, and welcome back from your little break. I am Lieutenant Commander Nelly Gazarian at the HHS Office of the Assistant Secretary for Health, and at the Office of the Infectious Disease and HIV/AIDS Policy. That’s quite a mouthful. So at OASH and OIDP, but more importantly I am an HIV pharmacist, and certified by the American Academy of HIV Medicine as well.
I heard the panel discussion was great, the opening plenary was great. I am dialing in from PACHA, which is the Presidential Advisory Council on HIV AIDS, from very sunny and hot Phoenix Arizona. So hydrate is the mantra here. But what a timely, timely discussion. I just got off a discussion talking about the workforce issues, particularly in our HIV STI communities, and how pharmacists play a key role in addressing this workforce issue.
It is a huge national momentum that we see that the panelists earlier discussed, as I was chiming in a little bit, to talk about how pharmacists are getting momentum in prescribing or furnishing HIV PrEP and PEP through pharmacies, and again so many activities and coalitions are coming together to support pharmacists. So, great timing here.
One of the key things that I want to recognize that pharmacies and pharmacists play a key role in is the access that stood out to me, and how pharmacists are uniquely positioned within communities to address the needs of their communities. There are programs that are specifically tailored towards those communities, and how communities trust pharmacists and talk to them about their needs. So you are basically the ear to the ground, and help us design a national strategy.
As you may have heard earlier from Harold Phillips, the Mighty Box 6 talks about the role of pharmacists. I’m here today to talk a little more about how pharmacists and independent chain pharmacies are playing a key role in helping us end the HIV epidemic.
We have Dr. Elyse Tung from Kelly Ross Pharmacy, John Wigneswaran is going to be talking a little bit about Walmart, joined by Ms. Aleata Postell. Bishar Jenkins from AIDS United to take a look at advocacy and how they play a role in helping pharmacists and pharmacies to meet the needs of the community.
And last but not the least, Kenric Ware from Mercer University College of Pharmacy, and Joseph Health Collaborative. Dr. Tung, are you online and ready to go? Perfect, take it over.
Community Independent Pharmacies: Furthering Innovation in Oral and Injectable PrEP Delivery
ELYSE TUNG: I am going to be speaking on the independent pharmacy side and their perspectives of how we’ve implemented our program. Community pharmacies furthering innovation in oral and injectable prep delivery. These are my disclosures.
My main take home message for today’s talk is going to be pharmacists in a community pharmacy can provide oral and injectable HIV PrEP care. So, just to give you a little background, we are a true community pharmacy located on a corner of downtown Seattle. We initially started with one location, back in March of 2015, and we’ve now expanded to two different locations in Seattle. Here you can see patients can come in and pick up their routine medications at the front counter.
In the background where you can’t see, behind those registers, are an over-the-counter product. If a patient expresses a need and a want to be on PrEP, we bring them into a private counseling room which is at the end of that counter by the wall. At that point the pharmacist sees the patient, completes all laboratory testing, counseling, and prescribing.
During the visit the technicians on the main floor in that open area that you see are typing the prescription, organizing patient assistance programs, and dispensing the medicine, so when the patient leaves the appointment that prescription just needs to be checked and the patient can leave with medicine in hand.
So here are the key elements of what is needed for a PrEP program in a pharmacy. First and foremost, the pharmacist must have a scope of practice that allows them to provide PrEP care. In Washington State, that Natalie mentioned already, we have a very generous scope of practice, and basically if we have written CDTA or collaborative drug therapy agreement or protocol on file, then we’re able to do anything under that protocol. Some states have other restrictions, but it is really important that pharmacists follow their local state laws.
Next, we’ve also talked about financial reimbursement for care. Pharmacists are only going to be able to provide this care if they are paid for their clinical services. And in order to do so, they need to be recognized as providers, both on the federal level and the state level.
So in Washington State pharmacists are recognized as a provider, and so we are able to bill for our clinical services just like any mid-level provider can for their time with the patient, for lab testing, for procedures such as vaccine administration, injection of long acting injectables, or even injection of antibiotics. We are not recognized on a federal level. So I am not able to bill Medicare plans. And we do know that there are people out there who are over 65 who still want to be on PrEP.
The next element is testing and sample collection. So the pharmacy has to figure out how are they going to get testing done, are they going to perform point of care testing and do laboratory send outs, will the provider do the lab collection, or will they send the patient to a separate lab to do that. Both are equally doable and work well.
We have decided in our pharmacy that the pharmacist will do all the lab collection. And so we have obtained our own phlebotomy licensing in order to do that. And then we also send patients to the rest room to do all their own sample collection for urine, throat, and rectal swabs.
There is a space requirement, there needs to be a private counseling area for these appointments to take place. And there needs to also be a plan in place for outreach and marketing. How are patients going to find your service? Are you going to do outreach mainly to community-based organizations in your area, word of both? Will you implement a traditional or an online media marketing plan? There has to be a strategy in place for people to be able to find you.
So, personnel. In the early phases, when we first started, it was just one pharmacist, myself, and one medical director who was on call for any extraneous circumstances or clarifying questions. And in the early phases these appointments used to be done as needed, as people walked in, and I would just pull myself offline for a few minutes to conduct these appointments, and then jump back into the staffing role.
As our service has grown, we have added more staff. We have a dedicated technician and ancillary staff. So we have one technician, and then a pharmacy assistant, that take care of all the billing, patient service representative tasks, follow-up phone calls, scheduling appointments, and doing a lot of benefit verification tasks.
We have also added additional pharmacists. So we currently have now 2.5 FTE dedicated to this service, and they are seeing patients back-to-back, and are fully booked just like any other provider office that you would see. And any other staffing roles that need to be done are filled by other pharmacists.
Our current services include oral PrEP, long-acting injectable PrEP, STI testing and treatment, HIV PEP, vaccines, and Hepatitis C treatment. Our up-and-coming services include DoxyPEP and gender affirming hormone therapy.
Last year we started long acting injectable. And we have discovered quite a bit. Most of these injections are either covered under a medical benefit or a pharmacy benefit. And it has been pretty much 50:50 on our side. Ancillary staff, we use for benefits investigation, whether or not an insurance is going to cover the long acting injectable is very arduous, and instead of dedicating pharmacists’ time to this we now dedicate our ancillary staff for this.
Purchasing of the medication is restricted to medical clinics only or a handful of specialty pharmacies in the nation. So a normal community pharmacy is not going to be able to purchase Apretude off their normal wholesaler and dispense it as normal. Because we are labeled as a medical clinic we are able to purchase it, and we are able to administer it either as a medical benefit or as a pharmacy benefit. And all the pharmacists perform all the administration of medication as well as all of the testing and anything needed for follow-up visits.
So really the take-home message is that pharmacists can provide PrEP care, and there is an incredibly large demand for PrEP in pharmacies. To give you an idea, since we have started, in 2015, we have started 1900 patients on prep, we have conducted over 13,000 follow-up visits, and of that we have about a 15 percent loss to follow-up rate, meaning people who are truly lost to follow-up that did not continue PrEP care on with another primary care provider or another PrEP clinic of sorts. We have seen over 1600 STI visits and treatments. And since 2020, when we started our telemedicine visit, conducting PrEP over telemedicine, over the entire state of Washington we have completed 1300 telemedicine visits.
And since last year, when we started our long acting injectables, we have conducted 56 long-acting injectable appointments, with about half of them being medical billed and half of them being a pharmacy bill. So there are lots of opportunities for pharmacists to get involved in these clinical services. There needs to be an increased opportunity for training, in order to provide these care.
Future needs, it is important that the scope of practice is in all that’s that allow CPAs and to allow PrEP care. And there also needs to be a recognition of pharmacists as providers on a federal level as well as across all states. Thank you so much for having me. And I’ll now pass it off to John Wig.
Community Chain Pharmacies: Achieving Scale and Reach
JOHN WIGNESWARAN: I was laughing. No one knows how to say my name. That was pretty funny. If you skip to the next slide, I just have a couple of points, and then I want to turn it over to Aleata Postell, who had some specialty pharmacy.
Actually, I'll just stop for a second. I'm Chief Medical Officer of Walmart. I'm a nephrologist by training, and the comments about the importance of pharmacists is really critical, particularly when I was practicing, particularly for kidney disease and dialysis, most people felt more comfortable talking to the pharmacist, and that was very welcome. Clearly very important.
For us, there’s always this question about Walmart in healthcare, because whenever we talk to people they don’t realize sort of the depth and breadth, and I thought I would tell you a little bit about that.
So we have close to 5000 pharmacies. What’s important about that is 4000 of those are in underserved areas, and there is a Walmart within 10 miles of 90 percent of the US population, with 150 million people coming through the stores every week. So we can really make an impact in people’s lives, and really just being able to talk about things that are important and that are actionable.
We have a couple thousand medical optometry sites. We have a food as medicine vertical where we’re selling into the regulated markets with SDOH, telehealth, et cetera.
So one of the reasons that many of us have come to Walmart from traditional healthcare is that it really represented an area where, this is not just Walmart, this is the retail sector in general, where you can do things that are very meaningful. And that means we can train our pharmacists differentially, or for example we just hired a Chief Quality Officer for Mass General. Instead of having to live in a big city, you might actually be in a rural area and experience clinical care pathways and academic rigor that you might not necessarily see. So those things are really important to us, and I just wanted to talk a little bit about that.
This slide is important because it really talks about how we mirror the population at large. And I heard a lot of comments about research. We just started a research institute at Walmart. And one of the reasons for that is not to become an academic center or a clinical research organization, but it’s that we’re able to get into the community and recruit patients that typically are not talked to about research. We had about five million people that signed up to get messaging on research. So we can focus on HIV, we can focus on ways to reduce stigma and talk about enrolling in studies that might be important to someone.
And so as we think about what we get involved in, we are really trying to do things that are actionable and that can happen right away. So many of the great ideas that I heard today, those are things that someone could come to us and say look, we’d like to educate differentially in this population, or we want to think about potentially using your scale to think about a cash based PrEP option, or doing your injectable in a store as part of kind of a healthy, buying the things that might be more important to you, or talking to your pharmacist. So we are really trying to take a look at that and with that lens.
And then before I turn it over to Aleata, I wanted to just tell you a little about the work that we’re doing in training our pharmacists. This was mentioned a little bit before.
So we partnered with Duke and the Elton John AIDS Foundation, which has been a tremendous partner for us, in trying to design a program to educate our pharmacists on the specific learning objectives. It’s a modular program, and it goes from talking about stigma and learning how to talk to someone from a different background, how to communicate, how to think about drug-drug interactions, how to think about new therapies.
And so really trying to raise the bar, where if you’re somewhere in the country like I mentioned before, you can actually have an approach to you that is just as good as if you’re living in a big city. And those are ways that have been very meaningful for us as we start to think about what can we do today rather than really trying to think about things that may not be impactful to someone who is living through it right now.
And lastly, the HIV disease in general is an extremely important disease for us, because it touches the communities that we touch. There is an opportunity for us to talk differentially to people. And many of you know, who live near Walmart, people really do have a deep connection to the store, whether it’s the people they see that are greeting them coming in the door, or the pharmacist that they’re seeing.
And so we really treasure that relationship, and try to work on things that can be impactful. So I’m going to turn it over to Aleeta, who is going to talk to you a little bit about our specialty pharmacy for the community, and she leads our specialty business. Aleeta?
ALEATA POSTELL: Thank you, Dr. Wig. We can go to the next slide. When we call out our specialty pharmacies in communities to explain what we mean by that. So many of the drugs that are needed to treat HIV are carved out to payer specialty lists.
And so as we looked at how to be best served, what we did was we took our existing Walmart retail locations and we added that specialty designation so that they’re able to service the patient.
And so these are pharmacies that are located in areas that are underserved, they are designated as a community-based specialty pharmacy, and they offer condition specific specialty services, and really focusing on HIV and our commitment to eradicating HIV and AIDS in the United States.
With our SPOCs, our Specialty Pharmacies of the Communities, we feel that our patients are able to access medications through their preferred method, and enabling more options for privacy for test and treat needs. And then what we are finding is that the patients have increased adherence and improved time fulfill and treatment. And they are receiving personalized recommendations based on risk factors and medication therapy.
Teams are made up of our pharmacists and our clinical services managers, and they’re very knowledgeable about the community and their resources that are available, and they work to connect the patient to these resources through the help of our community health workers.
Our pharmacists also recognize the need of when to engage with prescribers, and they inform them when they’re seeing gaps in care, when they are seeing that maybe they’re not following up with their labs, and we’re providing those behavioral nudges to remind the patients to keep up to date with things like their labs or their refills.
So we are excited, I am actually back fresh from a launch today, we have 70 of these locations that are opening this month. In anticipation of National HIV Testing Day we offered free testing at these locations, and we will continue to host testing events throughout the year at these locations to continue to raise awareness.
What we’re finding as we’re participating in these events, the engagement and feedback has been very positive and very encouraging. So with these launches, not only are we doing free testing, we’re also doing wellness screenings because we want to address the needs of the patients holistically.
And what we’re seeing is our partners are asking us how do they support us as we open up more locations. They’re also identifying maybe things that we need to look at from other locations that are underserved. And then the attendees that we’re servicing are very thankful that we’re making it so easy, and one of the things with why Walmart, is because as we looked at how do we remove the stigma, it’s normal. They may be coming to Walmart for their grocery needs or any other needs, and so we wanted to normalize it, and so these locations are well served to be able to address the needs of our patients.
What is also interesting is that where we are administering medications, some of our referrals are coming from prescribers, and this is particularly the case in rural areas where we have health deserts, and that provider of care may just be the pharmacist.
So for me it was compelling to see what Dr. Crawford shared in Georgia, where the PrEP and PEP prescribing clinics fit in comparison to the needs, and that is something we are finding is not uncommon. So our goal is as we open up these locations to leverage out footprint to address those needs. And as Dr. Wig shared, 4000 of our locations are in what HRSA has defined as underserved areas.
And then in partnership with the Elton John AIDS Foundation, our pharmacists go through that in-depth training that was created by Duke. And so to date we’ve had over 2000 of our pharmacy teams that have gone through the training.
And that training, what we’re hearing from our pharmacists has been beneficial because it provides them with advanced skills to be able to provide the needed resources to treat those living with HIV, but they’re also going through motivational interviewing, mental health training, so they’re able to engage with the patients that works in a way that works for them, and then connects them to vital services needed for their care.
And with our pharmacy teams it is encouraging because they are very motivated to do more, and they are so closely tied to the community, they really understand the areas, the geography, and what they need to have in order to serve out patients.
They’re already trained, it’s been their core function. So why pharmacists, is because they’re doing this every day, they’re providing counseling and intervention as needed to service patients holistically, which is just something that’s core to what they do. And so we feel that they’re very well positioned to expand their scope of practice, because this is something that they’re seeing the patient, what they’re feeling across all of their conditions.
Our locations are across 10 states, and we strategically looked at states that we felt were favorable to the expanded scope of practice, and then we’re leveraging our partnerships like we have with the Elton John AIDS Foundation to continue to advocate for the expanded scope of practice for our pharmacists.
So, thinking about where we go from here, we know from COVID that our pharmacy teams are vital in the care that was needed for our communities, and through these specialty pharmacies in the community, by providing them with the necessary resources and tools, we know with Walmart’s size and scale that we can continue to deliver and have an impact, especially for those that have needs that are living with HIV.
And then as we look to expand our impact, we are working to educate payers, drug manufacturers, to help raise awareness on the importance of the roles of our pharmacists and sharing with them the outcomes and what we’re seeing from being able to offer additional services through our specialty pharmacies to the community. And with that I will hand it over to Bishar Jenkins and Kenric Ware.
Discussant Comments: Meeting Community Interests
BISHAR JENKINS: Hello, my name is Bishar Jenkins. I’m a policy manager here at AIDS United. I’m also a person living with HIV, and that will inform some of the comments that I share today. So, pharmacy centered HIV care and services would expand our ability to reach communities that would avoid or be hesitant to present to a traditional health center or provider.
Many folks would feel more comfortable going to their local chain pharmacy, such as CVS, Walmart, or Walgreens. Further, the accessibility of these services definitely reduce barrier for folks who work during their nine to five business hours and might not be able to take off from work to tend to their HIV care during those hours.
With that, pharmacists should definitely consider expanding services beyond their existing hours, as we know that many chain pharmacies close earlier than the broader store. And I’ll also speak to some considerations for us to center when we’re thinking about expanding pharmacy centered HIV care and really centering equity. These considerations really fall into two different categories: Making sure that people feel safe, and making sure that people feel seen, and really seen fully.
And along those lines, ensuring that we are consistently training pharmacists in culturally competent care and requiring that training to include really an understanding of the ongoing impact of structural racism and its role in the HIV epidemic and its role in the lives of black and brown people living with HIV and vulnerable to HIV.
And also ensuring that that training has a sensitivity to the structural barriers that hinder adherence when it comes to HIV treatment, but also prevention, including housing insecurity, food insecurity, stigma, community violence, and the list goes on and on.
In addition to that, also thinking about the pharmacy space itself and how it needs to feel welcoming for people living with HIV and vulnerable to HIV. And this can be achieved by ensuring that pharmacists and pharmacist techs are fully honoring the humanity of folks who present to the pharmacy, and remembering that patients should not be reduced to clinical checklists, but that we’re actually asking patients how they’re doing, that we’re talking with patients rather than at them, and that we’re engaging them beyond their status.
In addition to that, also ensuring that language of justice is applied within the pharmacy setting to ensure that we can fully serve anyone that presents to the pharmacy. It is also essential that these services are comprehensive, and also can address STI testing and treatment, PrEP and PEP, sexual health vaccination, and finally also being mindful of the physical space at pharmacies. HIV care as many of you know should be rendered in locations where patients and pharmacists and pharmacy techs can speak freely and comfortably without being in earshot of other folks that are accessing services.
I know personally many times when I go to the pharmacy, I’m able to hear conversations that I really shouldn’t be able to hear, that those spaces should be sacrosanct for both the provider, in this case the pharmacist, and the patient that’s presenting.
So we really need to think creatively about in person engagement to ensure that people feel safe and that people feel fully seen when they’re presenting to the pharmacy setting. Thank you so much, and with that I’ll turn it over to Dr. Kenric Ware.
KENRIC WARE: Good afternoon. I am really fortunate to be here to discuss some of the work that we’re doing around evidence to practice, that’s affectionately known as E to P. And this work began back in 2021, and initiated out of Duke University. We’re indebted to our pioneering force behind the work really is Dr. Lance Okeke, an infectious disease physician there at Duke. Also fortunate to partner with Mr. Russel Campbell, who is the Director of the HIV/AIDS Network Coordination, or HANC, based out of Seattle Washington.
So we have had some really good opportunities to engage graduate and undergraduate campuses. So really what evidence to practice looks to do is to promote careers in HIV research among not only undergraduate but the graduate population as well, particularly pharmacy students.
So this work is funded by the DC Center for AIDS Research, and what it does is it really goes onto the campuses and has a three day interactive workshop on the campuses, primarily historically black colleges and universities or HBCUs, and over the course of that three days students are really exposed, really immersed in implementation science, so that was referenced a bit earlier, so students get some exposure to that, particularly the human centered design arm.
And students are also exposed through the HIV prevention research module, which is crafted or housed there at the HIV/AIDS Network Coordination. So this is really the background of the work that the students get to actually go on to produce what we refer to as an action plan.
So the students work over the course of three days to actually design an HIV prevention strategy for their campus. So they are trusted to be the context expertise to allow us to know how do we better reach individuals on college campuses.
So where have we gone so far? The initial work began in South Carolina, as we know federally there has been some attention drawn to the southeast as far as the HIV rates there, and South Carolina has been one of the priority states to really rethink how we do HIV prevention and how we reach individuals there who are at higher risk of acquisition.
And so we started with some of our undergraduate institutions in South Carolina. To name a few, we’ve been to Benedict College, which is based in Columbia, South Carolina, been to Allen University, also there in Columbia, Claflin out of Orangeburg, Vorhees there in Denmark, South Carolina and Moores College there in Sumter, which you can see we have kind of a mixture of urban and rural settings where we are looking to engage or we have engaged students at the undergraduate levels.
At the pharmacy school level we’ve been to Florida Agricultural and Mechanical University or FLOAMU, also been to Xavier, so in Tallahassee and New Orleans respectively. We’ve gone to each of these locations with the intent of exposing students to careers in HIV, and also helping them to craft an action plan that really is the culmination of the three days of work that they put into really actualizing how HIV prevention will look on their specific campuses. Students are compensated for their time, so on a daily basis participants do receive compensation based upon the funding that this work received.
The selection process. So, who actually participates in these workshops is really heavily reliant upon our faculty champions at the particular campuses. So we are indebted to individuals, really faculty liaisons that identify the participants, and in most cases really sit through three-day sessions as well. So they really have an active interest in what the students are learning in these particular sessions on each day, and so they are privy to the action plans that emerge at the end of the three days.
Evaluation wise, students will complete a pre- and post-assessment. So prior to beginning the activity, the Evidence to Practice or E to P, students will complete a pre-test, and also a post-test. And a subset of these students actually participate in in-depth interviews. So this would be something where we typically average about eight to ten students who participated in these workshops, and so a subset of those students will be contacted by the administrative group there at Duke, the evaluation group there, to actually participate in the in-depth interview sessions.
Looking ahead, so what are we looking to do going forward, or one of the main goals is to really circle back to these campuses to help these students to actually implement the plans they’ve come up with. And so there is definitely an intentionality toward actually helping students to implement these plans.
So we are actually strategizing now as far as which campuses we circle back to, and then what order. So some of those things are still ongoing, but we are excited about the progress we have made so far in this space, and the interest that the students have been able to really cultivate in HIV prevention research.
So I’ll thank you very much for allowing me to talk a little bit about our work there. Now I will turn it back over to Nelly. So thank you so much.
Questions for the Panel
NELLY GAZARIAN: Thank you so much, again. So much information was shared by our panelists. Again, thank you Dr. Tung, Dr. Wig, Aleida, Kenrick and Bishar. I absolutely appreciated, I want to give some shoutouts here, I know that the Kelly-Ross Pharmacy was one of the very first pharmacies to really start to do HIV PEP and PrEP. A lot of them have started to take that and replicate it. Again, a huge kudos to Walmart for your partnership with EJAF to design those modules that came out. Bishar, I really appreciated the thoughtfulness of the recommendations that you made for pharmacies to do.
Kenrick, again, going into what programming you’re doing within universities and helping the students implement the plan, but also thinking about more upstream factors, like this is the future generations of what pharmacists can do, especially as we know that those that are aging with HIV will constitute, they already do, for more than 50 percent of those living with HIV.
So I want to start off with some questions here. Please feel free to type away as many questions as you can, we will get to as many as we can, if not we will try to get you answers later on. One of the first questions that I have, and perhaps me being at PACHA and listening to the community, was community engagement.
So I wanted to pose a question to our pharmacy partners and see if you can share a little bit more about how you ensure this community engagement in some of the programming that you offer, and then I’ll flip it and go back to Bishar and ask to see what are some of the barriers that you have seen when you’re trying to engage with pharmacies, how would you like to see community engagement done differently by pharmacies? So I’ll go to pharmacies first and talk about how they incorporate community engagement in some of the work they do.
ALEATA POSTELL: I can share. While we feel that our community partners are really important, especially in those states that we need partners to help us with the testing. And so we engage with as many community partners as we can. We actually have a team that will work to arrange for us to know who those partners are.
And then also the Elton John AIDS Foundation, based on where we’re located, they’re also sharing with us recommendations for community partners that we should work with. And so we feel that is important for us, especially with our team. Being a part of the community, we feel that that relationship there helps us with not only building credibility, but also access. And so I think that having those partners is an important part of the strategy that we have with our SPOC.
ELYSE TUNG: I would like to reiterate the same thing, making sure that we have really strong relationships with our community partners is incredibly important. Early on, when our service was just being launched, there was so much outreach that was happening after hours, going to several different kinds of community based organizations when they had their events, and trying to support them and provide information and being involved in their in-services, and just being a resource for those organizations, whenever and whatever they needed, really helped develop those strong relationships that now really have carried us through even years afterwards.
NELLY GAZARIAN: Thank you so much. And I will flip it to see if Bishar has some lessons for us beyond that to see how we can better engage community.
BISHAR JENKINS: I definitely think thinking creatively around reaching out to communities and going into communities, and also expanding our mobile options within communities, but also app-based care. We know that many communities engage with apps across the board, and if there is a way that we can reach people in ways that work for them, we need to expand into those areas as well.
NELLY GAZARIAN: Thank you so much. I will jump to another one, that you all spoke a lot about pharmacies and all of the different services you offer, beyond the biomedical needs, is what I’m talking about. I know Dr. Wig you alluded to this earlier, talking about looking at food as medicine.
And overall we know within pharmacies and pharmacists address a lot of the social determinants of health that are so important for us to address before we can even talk to our patients about getting on HIV PrEP and PEP.
So I just want to see if overall, within the panel, if there were some ways that you can share that you were addressing those social determinants of health, because we know if someone is homeless the last thing on their mind is taking their HIV PrEP medications, until they can find food and shelter. I just want to see if we can unpack that part and how pharmacists play a role in that a little bit more. Dr. Wig, did you want to start with food as medicine?
JOHN WIGNESWARAN: Yes, I can give you a little bit, maybe an example on even beyond HIV. So for example, with diabetes, we have a very low-priced insulin option. But one thing that we have been talking about, particularly for people that don’t have significant means, is offering discounted healthy food options as part of sort of that bundle.
So it might be they get a discount to a Boost Shake or a low glycemic food. So being able to have that conversation is one part that we’re trying to do a wraparound with other things. Aleata might have some more on the HIV side within this box.
ALEATA POSTELL: I was just going to touch on the need for community health workers as part of the model. So we have employed community health workers that are actually addressing needs outside of dispensing. So, to your point, if they don’t have the appropriate housing, and we know that some of these medications might come with stewardship needs, how do we help them to get the needed housing or grants to support their needs. Some of them that we found is even just engaging with the caregivers to make sure that they have someone to support them through their care, or transportation.
So we found that the role of community health workers is really important. So if we have in our model a team of community health workers, not only just in our pharmacies, but also across our organizations, that is addressing those needs for the patient beyond just the dispensing.
NELLY GAZARIAN: Thank you for sharing that. Aleata, you alluded to something that I wanted to get to a little bit here. Being a pharmacist myself, working during the pandemic and even before that, we know that there is a lot on our plate. And you talked about this particular model where you engage community health workers. They’re so critical to what we do.
My question is, we know we cannot expect every pharmacist or every pharmacy to do everything. Let’s be real, that’s unrealistic, that’s why we are talking about specialty pharmacies. But what are some services or perhaps levels of services that you can share with the audience that you think everybody can do. Just a little bit, even if it's just talking about knowing your status or having a quick conversation, what are some of the things that you think they can do at least, and then you can go into deeper conversations as well. The next level would be this, the next level would be that.
ALEATA POSTELL: I am going to tie it to even the question that came across in the chat on independent pharmacies. I think one of the things is that prescriber engagement is really important as well, and helping the prescribers to understand what you can do for their patients, I think independent pharmacies are positioned well to build those relationships.
The other thing is, think about how virtual care ties in. So a lot of times in a centralized model it may just be I’m picking up the phone and I’m calling the patients, but in a decentralized model you can incorporate virtual care, if that is an option for you, for some of the counseling needs and checking in. So how are you engaging with the patient after they pick up their medication, what things are you collecting from the patient to make sure that they’re achieving the best outcomes.
And then we’re not able to fill everything, because you have a number of payer restrictions. Manufacturers may have restrictions on who can have access to their therapies. And so knowing in your surrounding areas who can service those patients and triaging them and making sure that they get linked to a pharmacy and not just doing that transfer and saying okay, call and et cetera, what is that extra step that you can make sure that that patient is getting their care, and then reminding the patient of the other services that you have to offer, so that you can maintain that relationship.
JOHN WIGNESWARAN: One thing to add to that, Nelly, too, is when I mentioned research as a care option, the way that we’re looking at the patient is not just that it is an HIV issue, it is more about how we are engaging them across their continuum.
So for example, if we were recruiting for a particular HIV study, even if that patient didn’t get recruited, that communication time is an opportunity to talk to them about their disease, or see a gap in care that could be referral to a pharmacist conversation.
So we are trying to see, and it is very challenging, as you guys know, to try to tie all of those things together. But part of our patient engagement strategy is to try to incorporate all of these things into some holistic message, rather than just compartmentalizing, it’s HIV, it’s something else. Frankly it’s far more continuous than that.
NELLY GAZARIAN: Thanks so much for saying that, Dr. Wig and Aleata, and sharing your thoughts on that. That is in some way destigmatizing it. Talking about your diabetes in the same place that you get your groceries done, it is destigmatizing, that is so important. I also recognize, and pharmacists recognize this, that HIV does not exist in a vacuum. Like, you have STIs, you have hepatitis, you have other disease states or comorbidities that come along with it.
So one question I perhaps have, and I will direct this one to Dr. Tung, is, and this will allude to one of the questions that came in as well. Dr. Tung, if you can unpack for us a little bit about engaging with other healthcare providers.
Because we are part of an interdisciplinary team, and we can start off patients, of course in California that’s how it’s started, you can start off patients on PEP or PrEP. But to continue that engagement with other providers is so important, because while we’re taking care of the HIV needs in this particular instance, we need to take care of other needs, and how we provide that linkage. And one of the questions is how are you able to bill for such services as well.
ELYSE TUNG: Yeah. We engage other providers throughout the whole continuum of care. So, in our program, one of the requirements is that people must have established care with a primary care provider. They can still continue to use us for their PrEP care, but they need to see a PCP sometime within a year of starting our service.
And a lot of the response that we’ve gotten in our community is that PCPs, especially PCPs in an LGBTQ plus community, are incredibly short staffed. There aren’t enough appointments, there aren’t enough providers.
And so what is helpful is having them come to us for their PrEP care, still continue their primary care at their PCP office, but that helps offload some of those appointments onto us to allow them to see more patients, more PCP type of visits. And ensuring that the patient continues to have that follow-up with that PCP is important.
As far as getting started with billing, it is an arduous process. But we got started with the process just like any other physician or ARNP would. We have to undergo the same credentialing process and contracting process as any other provider does.
And so there is guidance out there by I think the American Medical Association has a guidance on this. I know locally, in Washington State, the Washington State Pharmacy Association has a great handout and how-to guide on how to start billing for clinical services.
And so really recommend that tap some of those resources to start the process. Credentialing typically takes about six months for an individual pharmacist, and then the person has to get contracted with each and every single insurance that they want to be able to bill under.
And some insurance providers can contract you pretty quickly, in a couple of months, and some plans take six to nine months to contract with. Though the first year that we started billing it definitely took anywhere from six months to 12 months to get completely fully up onboard with all the insurance plans to be able to bill.
NELLY GAZARIAN: Thank you so much for your comprehensive answer there. The joys of not having provider status and the state scope of practices, right? We love doing this. The next question might be perhaps directed to Kenric. Kenric, you talked about a very innovative approach that your university is taking to look at how pharmacists and pharmacies can play a bigger role in coming up with their own plan, in implementing their own plan.
I was wondering if you have some tips or ideas to share with other universities on just how to engage your entire workforce really, talking about pharmacy interns, as we know you really tapped into our technicians as well, pharmacy interns as well during the COVID response. And see if you can unpack that for us a little bit more.
KENRIC WARE: Thank you for the question. I think one of the things, from a pharmacy school perspective, is really looking at optimizing some of the advanced pharmacy practices, appearances, or the (inaudible) the last year of rotation that students undergo in pharmacy schools.
We’ve found some favor there where pharmacy students who are out exploring what they want to do with their pharmacy career once they’re done. Instead, having gone through pharmacy school myself, I recognize that sometimes in the didactic portion of pharmacy school, you are just kind of making it through to the next test, to the next week.
I think during that final year where students can somewhat decompress and say hey, what do I really want to do with my career, then we’ve really found some favor there with implementing this workshop, saying hey, have you considered HIV related careers, and this is what we can offer you as far as mentorship, and then also with them creating the plans and really how it would work on their specific campus.
I think one of the benefits of this work is that each campus that I named, obviously there is different culture there, different constraints, so having the students to really talk through how does this look on our campus, who do we need to contact, who are our point people, who are our champions here.
But from a pharmacy perspective, a pharmacy school perspective, I definitely think that final year of pharmacy school is where students are able to really kind of digest this concept a little bit more and really see it playing out, because they are so much closer to graduation than when they started.
NELLY GAZARIAN: I absolutely love that. In fact it was in my last year of pharmacy school that I was exposed to HIV down in South Florida, and it has been my passion, and here we are, embedded in this work. Thank you for sharing that.
And perhaps if I can piggyback off of something you shared, bringing in Bishar into this conversation as well, and Bishar you alluded to this a little bit earlier, one of your recommendations was particularly training for pharmacists.
Now, I will say, I’m a fairly recent graduate, I graduated in 2015, so not that long ago. There was a lot of biomedical training. But in some ways there was a training component that was missing that I almost had to learn on the job, which was talking about stigma or cultural competency, talking about how to really look at disparities within the LGBTQI plus community.
So I wanted to see if Kenric, Bishar, you want to jump in, others as well. Where do you think it is that some of the training components that you think may be very helpful for pharmacists and future pharmacists or pharmacy students that you could share with us?
And I’m being a little bit biased here, because I don’t know if American Pharmacists Association announced this earlier, but we’re working on a training for pharmacists related to HIV PrEP/PEP STIs. So it will be very helpful for me to take it back as well to ensure that we are capturing everything.
BISHAR JENKINS: I think one of the things that I think would be beneficial, particularly in training pharmacists, I think many folks that are providers, both on the medical side and on the pharmacy side, still think of HIV in a gay context, and that erases the epidemic’s impacts for folks that are cis-het for example.
So if we’re able to really expand just how we imagine the epidemic and understand that there are many different types of folks that are impacted, of all genders, of all sexualities, I think that would really reach folks that are often erased in our collective narratives around HIV.
ALEATA POSTELL: I just want to double click on that, because the population is aging, but also we have to think about, so one of our events, I had a chance to speak with a group that was supporting some of their local homes and long-term facilities. She shared with me the number of times they go into those facilities and they have to educate them on PrEP, it was significant.
If pharmacies can do more on that and think about that differently. But I think that we don’t think about that group. To Bishar’s point, I think expanding who we are looking at to include the aging population as well is something I would add to training.
KENRIC WARE: I will add, from a pharmacy school perspective, I think some training as you mentioned, through pharmacy school we get a lot of information about the biomedical preventions and the side effects. But I think the training should really focus on some of the barriers that keep people from picking medication up on time or things that may impact people’s ability to adhere to therapy.
In a pharmacy setting, again we’re focusing on the therapy, and the assumption is the people are taking the medication that’s prescribed, because why shouldn’t they, we have all this evidence behind it. I think we’re really doing a disservice to pharmacy students about all of the other contextual factors that keep people from being able to pick up their medications on time and to consistently adhere.
And if you change the negative around not blaming individuals for not picking up their medications, having worked in pharmacy settings and continuing to do from time to time, is the connotation around well why didn’t you pick up your medication, it has been here for two weeks. I think changing the language around that and really understanding some of the challenges that people have, and understanding that perhaps picking up their medication wasn’t at the top of the list at this particular point in time.
I think pharmacy school, again, we really make the assumption that people should pick up their medication every single time, on time, if not it must be a fault within them, and I think we just need to reimagine how we had that conversation at the pharmacy school level, and really explore other factors that keep people from consistently picking up their medication on time, and what can we do as pharmacists, again a nod to Walmart and other organizations that are looking at how we can really help pharmacists to really be more sympathetic about that.
NELLY GAZAIAN: Thank you so much. This is very useful information, especially making sure that we are equipped to go out and answer the needs for our communities in a respectful manner. One question that came across was perhaps with Walmart, related to pharmacy data, if it’s being held at health departments, just to ensure this is an opportunity to explore engagement or reengagement in HIV care.
ALEATA POSTELL: Yes, it is. But to tie in, we’re also looking at the data ourselves, to look at how we continue to engage, and then address any barriers in adherence. As we’re looking at our outcomes, we want to understand why the patient may need to be engaged differently. So I think there is an opportunity for yes, we’re sharing it, but as sort of practice of pharmacy you should also be evaluating that data as well on how you engage.
And then I just want to tie it back, there was a question on the software. With software, be sure you have ones that can also do the billing of the services, both for medical and pharmacy, if you can have it combined, that’s great, but it goes back also to the data as needed.
So you’re going to have to be able to demonstrate to the payers that you’re achieving the outcome that you’ve set out, because some of them are putting restrictions in place where you have to demonstrate that. I would say also making sure that you have the right system that can give you the right dataset that you’ll need for evaluation.
NELLY GAZARIAN: Thank you so much. And I know we’re getting close to time. This next question is perhaps for all of you, to help, As you know there are a lot of federal folks on the line, to help us address some of this. One from my perspective is, if you are to make policy recommendations on a federal level, what will they be. I can kind of guess, but I wanted to hear from you all.
And the second part of my question is, as you all know this is a meeting that is held by NIH, and we talked a lot about research. We wanted to hear a little bit more about what have your experiences been in partnering pharmacy-based research, particularly in HIV. And do you have any recommendations for formulating future research projects or teams?
JOHN WIGNESWARAN: I can take the research one first. The first phase of the research institute is really to think about how we engage patients, even participate in clinical studies. And so a lot of the conversations have been more around there is a lot of stigma associated with it, just research in general, when you put HIV into that, and this is to Bishar’s comment, it just becomes a little disproportional in terms of how people think about it.
What we have found is that because we are the direct provider to individuals that are using our pharmacies, there is that trust and relationship. And so one part that the pharmaceutical sponsors have been very interested in, and this is in all retail players, is that because you have that relationship it is going to be very different me reaching out to someone and saying you know, I understand you’ve had this disease for X number of years, or a family member might be facing the same thing, would you like to learn about a potential study that might be impactful?
When it’s coming from that perspective, rather than from a random text or an advertisement sending someone to an academic center, it’s very different. So it comes back to this theme of being in the community and asking the question from a trusted perspective.
NELLY GAZARIAN: Anybody else have any ideas on any federal policies that you would like us to work on, or any recommendations for formulating future research?
ELYSE TUNG: For the federal policies, it is really important that pharmacists get recognized as providers. There is a whole group of people who are insured by Medicare, but pharmacists cannot bill for Medicare services, and that really limits where they can go if they want to go to a pharmacy to receive their care or not. So, really important for the federal government to really push that agenda through.
And experiences in pharmacy-based research, we do conduct some research here at our little independent pharmacy, and one of the things that constantly gets brought up is that it takes a tremendous amount of personnel and resources to implement this research that needs to be funded some way. And utilizing current staffing structure is just not feasible.
NELLY GAZARIAN: Thank you so much. Going once, twice, before I make my closing comments, I want to see if anybody else wants to just comment on anything, or just add a few little, your extra cent? Go ahead, Aleata.
ALEATA POSTELL: I think we have heard about the roles of the pharmacists. I just want to go back to what Dr. Tung was saying, I think it is really important at a federal level to understand that, and then also I think look at some of the restrictions.
I think if we could answer it at the federal level on allowing the pharmacist to bill for those services, the payers will follow. So we do need for that to be opened up, and then really if we are wanting to answer the call, recognizing the role of the pharmacist in the community and how they serve is really important, otherwise it has already attacked health systems, and so just understanding what the pharmacist can do and how they’re already administering care I think is going to be really important.
KENRIC WARE: I wanted to add real quickly, I know we’re shedding the limelight on pharmacists, but obviously in a community setting or really any setting, pharmacy technicians play a huge role as well. So I think kind of having an eye toward how do we, I don’t know if standardize is the right word, but how do we figure out a way that we can incorporate pharmacy technicians into this conversation a bit more, empower technicians, because in any community setting, I lean toward community, but really any healthcare setting, while pharmacists are working, technicians have a huge role there.
So I think if we don’t start including them a little bit more they may feel a bit disenfranchised and a bit alienated from the process, and then it is kind of a butting of heads within a pharmacy setting. So I think some kind of way of getting more attention to the importance of pharmacy technicians and how they can help support this work.
NELLY GAZARIAN: Thank you for adding that, Kenric. Absolutely. We should be leveraging our entire workforce here. And again, just to end, and I will pass it on to Michael in a sec here, but obviously pharmacies and pharmacists are dedicated to help improve outcomes for patients in their communities. And not just HIV related outcomes or biomedical related outcomes, but overall quality of life, and that ultimately will help us. And I really truly believe pharmacies and pharmacists can end the HIV epidemic. So again, thank you to our panelists for being here, and sharing your experiences and thoughts and ideas with us, and I will pass it back to Michael.
Live Poll 2: Characterizing our Meeting Community
MICHAEL STIRRATT: Nelly, thank you so much. And thank you to all of our panelists. We want to build on this important discussion about meeting community needs by asking a little bit about our meeting community. We would like to get to know you a little bit. And so we do have questions here, two questions before we go to our break. You can access these through the Menti system. And you can do that by scanning this QR code on the screen with your phone, or you can use your bowser to navigate to Menti.com and enter the code on your screen.
Here is our first question, it’s about your primary work context. What is your primary work context? We’re curious. Would you identify yourself primarily as an HIV researcher or practitioner, as a pharmacist or a pharmacy workforce professional? Are you a part of a community-based organization? Are you working in the government, or are you working for a company, or industry partner? We’re also curious if you may be a student.
So we do have people that are logging on to the menti.com system, and feel free to do that, using either your QR code scanner on your phone or by using your browser to navigate here. And we have responses that are starting to roll in. Thank you very much.
It looks like we have people signing on, which is great. And we are asking, again, about your primary work context. If you identify yourself as an HIV researcher, pharmacist, community-based organization, industry partner, government, student, or other. And feel free to register your –
it looks like we might have an issue with the system. Is there a way to advance to the next question? We do have responses here. Maybe there is a way to refresh on that. We do have two questions here. One question is about your work context, and another is if you have had involvement to date, involvement in HIV service delivery through pharmacists, pharmacies, or the pharmacy workforce.
We apologize if there is a glitch in our system. Hopefully people can navigate through the two questions that we have here, and both of those polls will be open. Let me just check that we have a connection. It looks like we have responses rolling in, but I’m not sure that they’re coming out to our screen.
Go ahead, why don’t we have people continue to enter your responses there, it looks like we have more than 100 people logged on. But I’m not sure that we’re getting all the responses just yet. So please do enter your answers to those questions, and we will begin to tabulate those, and perhaps we can report them back when we return.
We’ll be back at five minutes to the hour, that’s at 3:55 Eastern. And when we do return, I want to tell you a little bit about an opportunity that we have to invite your feedback on what our future research priorities should be in HIV-related pharmacy service delivery. So we’ll talk about that in about five minutes, as we go to break. And thank you for continuing to enter your responses into the mentee system, we appreciate it. See you in five minutes. Thanks so much.
Topic Panel Two: Advancing HIV Testing through Pharmacies and Pharmacists
Research Gap Idea Collection: Introduction and Invitation to Contribute
MICHAEL STIRRATT: Welcome back. This is an exciting meeting. It’s a fast-paced meeting. And actually I will ask the organizers to bring up our base slides. We’re looking for the slide on your input is invited. Yes, thank you. So I mentioned an opportunity to help us inform our future research priorities, and it’s right here.
So in addition to the information we’re getting from you from our Menti polls, we also want to ask if you would be wiling to take the time to write us a short response to this question. Our question is: what research is needed to further advance pharmacy centered HIV service delivery? And we will be open to all responses. We would invite you to send your short email, your short response to this question, to the address that’s on your screen. That’s NIHpharmacyHIV@nih.gov.
And we will be tabulating those responses to help us program our future efforts in this space. So we really appreciate your involvement in the meeting today, your attendance, but especially your input on these important future research directions that we should undertake here at NIH, in the pharmacy, and pharmacist centered HIV delivery space.
Okay, thank you very much for that. And we will now pass to the next panel moderator, how is my colleague from NIAID, Jason Hataye. Jason, take it away.
Panel Speaker Introductions
JASON HATAYE: Thanks, Mike. Good afternoon, and welcome to topic two, Advancing HIV Testing through Pharmacies and Pharmacists. I’m Jason Hataye, a physician scientist in infectious diseases, and your moderator for this session. I joined the National Institute of Allergy and Infectious Diseases in 2011, and since 2019 have served at the NIAID Division of AIDS and the Basic Sciences Program.
The Basic Sciences Program has a $350 million portfolio of research, mostly grants. Fundamental science takes a large chunk of those grants, but we also advance translational, clinical, and epidemiologic research for HIV.
As part of this diverse research portfolio, Dianne Lawrence in our program, leads an initiative on HIV self-testing that is entering its third iteration, with the goal of developing sensitive and specific detection of HIV RNA and/or protein that is both simple and fast. This is early-stage research, but we hope some of these concepts can eventually be developed for at-home or point-of-care use, such as in a pharmacy.
Today, we have four distinguished speakers who will discuss HIV testing in pharmacies. Speakers, please turn on your cameras for these introductions. Donald Klepser, PhD, MBA, is a professor of pharmacy practice and science at the University of Nebraska College of Pharmacy. Dr. Klepser will introduce us to his work on implementing point of care testing and a collaborative HIV screening program in pharmacies.
Next, we will hear from Mr. Drexel Shaw on lessons learned from HIV screening initiatives at CVS Health. Drexel Shaw, MPH, is the National HIV and Sexual Health Liaison of CVS Specialty Pharmacy and brings a strong background in patient advocacy and developing interventions for HIV prevention and treatment.
Jenny Liu, PhD, MPP, is an associate professor of health economics in the Department of Social and Behavioral Sciences at the University of California San Francisco. Dr. Liu will provide us an international perspective in her talk titled Ambassadors For Health: A Community Randomized Trial to Support HIV Testing and Contraception Access Among Young Women Through Drug Dispensing Shops in Tanzania.
And finally, Dr. Dima Qato will present Considering Pharmacy Locations and need to Bridge Pharmacy Deserts. Dima Qato, Pharm D, MPH, PhD, serves as the Hygeia Centennial Chair and Associate Professor in the Tidus Family Department of Clinical Pharmacy at the University of Southern California. Please refer to the complete bio sketches for more background on each of our four speakers.
For this session we will hold questions until the designated discussion period immediately following Dr. Qato’s talk. As questions come up during the talk, please direct them to a specific speaker in the Q&A box and consider stating your organization slash affiliation. Now let’s begin the first of our four talks with Dr. Klepser from University of Nebraska.
Implementing Point of Care Testing and a Collaborative HIV Screening Program in Pharmacies
DONALD KLEPSER: Great. Thank you so much for having me. It really is an honor. Mostly it is an honor to be on with another health economist. Rarely do I get to be on a panel with one other like-minded person. So I am happy to be talking a little bit about the research we have been doing around point of care testing in pharmacies really for the past decade-plus. And this is probably when I need to recognize my disclosures. A few of those there.
And so really the idea is pharmacies can increase access to HIV testing and care, and I think that that has been pretty well covered over the last few hours. I will admit that is not how I got here, how I came to this. Really the work we have done early on was around point of care testing in pharmacies for things like influenza and Group A Strep, and really the conversations with both pharmacies and with diagnostics manufacturers were what’s next, what else could we be doing, how do we make this a sustainable model in the pharmacy settings.
And so obviously a lot of this background, you all know this very well. But as we started talking, there was a recurring theme, and there was a recurring thing that came up in conversations, and it was related to HIV, and just the number of patients, the number of individuals, the number of people who didn’t know their HIV status, and the need for broader screening, and the lack of access in certain areas.
And so certainly you lay that over with the populations at greatest risk for HIV infection are also the least likely to have access to a primary care provider, and live in communities with community pharmacies, I think it opened up an opportunity for us.
And so really we started with the questions of, would patients be willing to be tested for HIV in a pharmacy? Would pharmacists be willing to test for HIV? And we’ve talked a lot of things today about that. And, can pharmacies implement an HIV testing program that complements what is happening in the community?
And so, some of our earliest work, they were surveys. We talked to pharmacists, we talked to patients, we talked to people in the community and just asked them does this resonate with you, does this make sense. Certainly we receive positive responses, cross-sectional surveys of adult patients showed interest in pharmacy-based HIV screening. It was high among participants representing the age and race groups disproportionately affected by HIV.
And then when we talked to pharmacists, and I know what you’re thinking, pharmacists in Nebraska and Iowa are probably among the most conservative, and maybe least likely to be interested in this.
So admittedly there was limited familiarity with PrEP-type programs and other screening, but there was a willingness to provide PrEP through collaborative practice agreements, with some additional training. Certainly studies that others did talked about pharmacists feeling that offering HIV testing was a reasonable addition to their evolving role. So I think there was an absolute positive and incentive for us to go forward.
And so that really led into the pilot study we started again in October 2011. That feels so long ago, the idea of doing testing of any kind in a pharmacy was still pretty unique. So we did this in just two pharmacies in Michigan.
Small numbers, I’ll never claim that it was thousands of patients. Really only a single patient that had a reactive HIV test and then referred on for appropriate care. But I think it was very insightful, at least for us, and educational, in that yes this could be done, and yes, these were some unique pharmacies, these were some trailblazers willing to get out and do something others weren’t doing at the time.
But it also showed us that we can provide this service in a pharmacy setting in about 30 minutes. So now all of a sudden that’s a reasonable ask of a pharmacy, when you include the technician, when you do all of these other things, to help with workflow.
I think when you talk about the population that it was hitting, this was the first HIV test for 42 percent of the participants, many of whom reported high risk behavior. So it really was connecting with the right population, and the response and the perceptions were favorable. So we really demonstrated the acceptability and feasibility of this type of testing.
And so then we rolled it out on a much larger scale, really for us, into a prospective, multicenter program from July of 2015 through August of 2018, and brought in 61 pharmacies in three regions, the Southeast, Mid-Atlantic, and Midwest.
And offered this screening for both HIV and Hepatitis C, and then worked very closely with state and local public health departments to have referral programs in place. And certainly, we have heard a lot about that, about that partnership that needs to happen.
So, again, a relatively modest reactive result rate, only five out of 612, a little bit higher with Hepatitis C. but what we found again is that patients at increased risk of HIV or Hepatitis C would benefit from this screening for infection at the community pharmacy. And it was that ease of accessibility to the testing, coupled with the strategy for linking to care that hoped to improve the outcomes, and really got these people the care they needed.
So really, to circle back, it’s the idea that you can do this in a pharmacy. And certainly, there was a small pandemic that got in the way and distracted pharmacies, as it did with many other healthcare providers, and the landscape has changed for both positive and negative.
We talk about wellness, we think about burnout, there’s real concern about adding anything else to the pharmacy plate. But I think we have also, on the plus side, we have demonstrated the ability of pharmacies to stand up and provide the service, and we’ve raised awareness.
So, what is next? Certainly, the previous slide about research opportunities, I’ve got a whole lot of ideas. But as we have heard from others today, getting rid of any of those regulatory and reimbursement barriers. There are pharmacies who want to do this, who don’t know how to do this, who probably don’t have the energy to do this on their own.
So working with state, local, and Federal public health and community organizations to create turnkey solutions for interested pharmacies. We can’t expect every pharmacy to create their own solution on this.
And obviously demonstrating the value and ultimately impact on HIV patient outcomes. And then if I can be just a little bit maybe controversial at the end, if we could get to a pharmacist driven test-to-treat model, then we can do it in house. So I appreciate it, and I am pleased to be turning it over to Drexel Shaw.
Lessons Learned from HIV Screening Initiatives at CVS Health
DREXEL SHAW: Thank you Dr. Klepser. I just want to echo Dr. Klepser by saying thank you, all, it’s an honor to be speaking with you all today. My name is Drexel Shaw, and I’m the National HIV Sexual Health Liaison at CVS, and I’m excited to talk to you all today about some of the amazing advances we are making really to increase equity and to improve access and quality for everyone everywhere.
So today we will be focusing on CVS. As I mentioned, some of our HIV testing initiatives, some lessons learned from some of those initiatives, and also highlighting how we’re coming together to use some of our unique capabilities within our pharmacy and assets to really end HIV through testing.
So I just want to center us by saying we have a commitment as an organization to health equity really to drive not just our consumers and colleagues in communities, but work on ways that we can make access to care available for everyone, particularly those in marginalized communities.
And so, to level set, our commitment and focus to ending the HIV epidemic addresses key challenges such as many of the speakers have alluded to today, around communities disproportionately affected by HIV, expanding access to testing, and reducing stigma.
Because of those unique capabilities I mentioned, we’re making ongoing efforts to really improve that patient experience with CVS, advancing our health equity principles, increasing education awareness and testing, and access really to treatment optimization.
Our strategic approach to addressing HIV disparities. So we outlined three goals this year particularly around health equity to really zero in on. And it is really around prioritizing the Ending the HIV Epidemic initiative, really looking into those guidances that are available publicly, and seeing how it aligns to how we can best reach communities disproportionately impacted, secondly improving patient experience with CVS, and lastly elevating CVS in the community, which I’ll get into detail.
And so as I mentioned on prioritizing the EHE initiative, we are focused on increasing HIV testing, particularly in our retail clinics and pharmacies, and through innovative approaches. And increasing PrEP program enrollment to support pathways from diagnosis to treatment.
Currently we are using tools to better identify gaps in care. We have a large warehouse of data that we’re able to sift through to be able to see how we can really close some of those gaps and create innovative programs, really to build trust and to improve outcomes, particularly for communities of color that have been disproportionately impacted by HIV.
And so as we look at testing, we will continue to focus on how we can improve the community experience with CVS, which means how do we enhance testing experience and options for people, how do pharmacy improve how we engage persons around support prevention option regardless of if a person tests positive or negative.
And so CVS is connecting patients and providers with the information they need when it regards around the journey for them. And so we want at the end of the day, regardless of where you live, to think of CVS as an option for your pathway through local engagement and through using many of the digital tools that are on this slide.
And so one interesting way how we are increasing testing is through our in-store clinics called Minute Clinics and Health Hubs, which are located in many of our CVS stores across the country, they provide HIV testing on site, as well as our Health Hub locations provide laboratory testing for persons for HIV, as well as if it is at a Minute Clinic location they can order a test if a person is 18 years or older. So it’s in the community for many people.
And so, lastly, in order for HIV testing to be advanced, we really must as I mentioned elevate CVS and pharmacies in general as an option for those who are seeking testing, and particularly those pharmacy settings that have in-store clinics.
And this is really where I want to zero in for us in our conversation today. And so as we think about innovation for pharmacies and healthcare organizations, I would like us to think about this program that we launched last summer. And so in honor of National HIV Testing Day we offered a free HIV screening voucher program between June 29th and July 13th.
And the program provided no cost, free HIV testing, at select Minute Clinics and Health Hub locations in five different metropolitan areas across the country for persons 18 years and older. And so it was in Atlanta, Houston, Miami, Orlando, and Dresden New York.
And so persons 18 and older were able to find this voucher program through the website, through the internal website, on social media channels, and our community partners, and they accessed the voucher through downloading it on their phones and setting up an appointment with a minute clinic provider.
And they would bring that voucher with them on their phone to that location and get tested, as well as a standard physical, which included biometric screening, blood pressure check, and physical evaluation, which allows us to address not just HIV but the whole person.
We were successful in developing really a largescale omni-channel marketing approach, which really allowed us to collaborate across all our unique capabilities that I mentioned, in collaboration with Gilead Sciences, in collaboration with many of our community-based partners and local health departments in those markets. As I said, that was the first time for CVS to launch a program like this and its offering, and over 217 persons actually downloaded the voucher through our website alone, and a portion of those persons were tested for HIV.
So, what are some lessons learned? There is not a one size fits all for a community. People need options that are convenient, accessible for them, they want to feel comfortable, they want to know that their options, that they are able to get tested regardless of the results.
And we also should look at retail health clinics for pharmacists and other health professionals around engaging persons around HIV testing as it aligns with the National HIV AIDS strategies, that retail clinics for some are accessible, less stigmatizing, for some to get tested.
And then lastly, I would say due to stigma, HIV testing by itself can be a deterrent for some individuals. So offering HIV testing in conjunction with other tests like COVID, other STI testing, other chronic conditions such as diabetes or heart disease, has shown great promise in increasing the numbers of individuals tested.
And so ending the HIV epidemic with the help of all of us on the call are able to be achieved with these three factors: Education and awareness, access to PrEP and PEP, as well as widespread testing and timely treatment.
So that’s all we have for today. I just would like to say I want to thank everyone for listening to us today, and I will turn the next portion over to our next speaker, Dr. Jenny Liu.
AmbassADDOrs for Health: community-randomized trial to support HIV testing and contraception access among young women through drug dispensing shops in Tanzania
JENNY LIU: Hi everyone. I am Dr. Jenny Liu. Thank you, Drexel, for the introduction. I am not sure if my video is working, but I will nonetheless forge on. Thank you everyone. Good afternoon. I really appreciate you inviting me today.
So far we’ve heard a lot about pharmacies, both big and small. I’m shifting gears a bit, away from pharmacies and towards very small community drug shops that are only allowed to dispense an approved set of over-the-counter products. Which is common. This type of drug shop is common across sub-Saharan Africa and lower income countries.
In Tanzania, these shops are called ADDOs or Accredited Drug Dispense Outlets. So our study involving ADDOs, called AmbassADDOrs for Health, is a joint effort between our University of California team and colleagues in the Tanzania Ministry of Health, local NGO Health For a Prosperous Nation, and (inaudible) supporting digital pharmacy records. You can see our website for more information.
In our body of research, we found that these private drug shops have the potential to vastly increase service reach for adolescent girls and young women who are at high risk of H IV transmission and unintended pregnancy. However, unlocking this potential is going to require special focus on finding a sustainable business model for this type of drug shop while maintaining access for hard-to-reach vulnerable populations.
This is something that the market can’t solve on its own. Our studies aim to solve this puzzle, starting with enabling access to HIV and pregnancy prevention services, with oral fluid HIV self-test kits and contraceptives.
This depicts our research journey. Our guiding framework is the idea of designing for scale, shown at the bottom. We’re bringing together approaches from human centered design, behavioral economics, and implementation science, to design an intervention with an eye toward real world implementation and scaleup from the get-go.
So first, through an R34 in steps one, two, and three, we used human centered design and behavioral economics to design our intervention. Human centered design is especially useful for this type of situation in that it roots solutions in the needs of the actors involved, identifying the momentary influences that derail young women from seeking preventive services.
So, for example, one insight we learned is that young women frequent ADDO shops, but often only as a mundane chore to get products for others. If she needs something for herself in response to an acute need, the experience is fraught with fear to ask for a sensitive product kept behind the counter.
So piecing together through an iterative process, brainstorming and vetting, our final solution to the many care seeking pain points for young women was an enhanced loyalty program called Malkia Klabu, which I’ll show you in a minute, that’s delivered by shopkeepers. And in it we embedded many behavioral nudge strategies designed to reduce the friction of care seeking.
For example, one piece of our solution was to elevate the salience of reproductive health products in the shop by putting sample products in a bright pink display within easy reach for hands-on learning. And then we’ve completed step four, we’ve piloted and evaluated the initial intervention using implementation science, and I’ll show you the results in a minute.
And now, currently, we’re conducting a hybrid implementation effectiveness trial complemented by an R03 study for focusing on sustaining shopkeepers’ motivations for supporting young women’s’ health. In the future we’ll turn to other pieces of the puzzle for sustainability and eventual scaleup.
So let me explain why we’re focusing on these small ADDO drug shops. These drug shops are owned and staffed by community members. They sell medicine, health products, and give consultations and diagnoses, sometimes beyond their scope of practice. But importantly these are often the first people and point of care for many in low resourced settings, and especially in rural areas where pharmacies don’t go.
These drug shops have been successfully leveraged for a wide range of services for malaria and diarrhea, but not yet for HIV prevention. Thus, there is a growing evidence that ADDOs can promote good health behavior and bridge gaps in health services, including providing contraceptives, pregnancy tests, and informal counseling. But they remain underutilized in health systems because most do not have formal pharmacy training, and their survival rests on a unique confluence of business, regulatory, and social factors.
Now I’ll explain our intervention. The Queen Club, or Malkia Klabu, is infused with multiple behavioral economic strategies, but the core is a loyalty club program. So all goals appearing to be young are eligible to join, and when they do so girls get a free HIV self-test kit by default, as a gift, and a loyalty card with girl friendly branding seen here on the upper right.
The card is punched if girls make a purchase, and the punches can be redeemed for cheap mystery prizes, such as small lotions or perfumes, specifically chosen to infuse positive affect into the engagement. And at any time members can get a free HIV self-test kit, pregnancy test, and other over the counter contraceptives, simply by pointing to the symbols on the back of the card seen on the bottom right.
Shopkeepers were trained to dispense the kits and contraceptives, give referrals for clinic-based care, display sample products in accessible location in the shop, and offer tablet for girls to watch informational videos about the loyalty program and how to use the program products.
In our pilot we randomized 20 shops one to one to the intervention and comparison arms. All shops were given HIV self-test kits to give away to girls for free, and this was so we could test the added value of the Malkia Klabu solution irrespective of price barriers. The pilot was designed to measure demand, acceptability and feasibility, and process outcomes.
And over four months we found that in comparison to control shops shown in grey those offering Malkia Klabu shown in orange had nine times higher patronage from young women, two- and 35-times higher distribution of HIV self-test kits and contraceptives respectively, and made many more referrals to clinic services.
So from the pilot we learned that distributing self-test kits through drug s hops is safe and highly convenient for young women. Demand for the kits was much greater than expected. And in fact the initial experience with HIV self-testing helped young women to consider contraception over time. Moreover, many of the behavioral strategies that we incorporated into the intervention worked as we had intended.
So in other words, girls could get the products without too much hassle, and business owners found that their customer traffic and sales were up, a clear win/win. Some shopkeepers even earned recognition as a champion of HIV prevention in young women’s health in the community. So in this way, Malkia Klabu met the needs of both young women and business owners, and motivated them to work toward a common goal.
Building on this, we designed a hybrid implementation effectiveness trial, now in the field. It has four aims. Aim one assesses the population level effects of Malkia Klabu on HIV diagnosis and pregnancy amongst young women. Aim two is centered around young women’s individual level behavior changes.
Aim three looks at supply side implementation and fidelity. And finally aim four is our R03 add-on study which goes further to test how to sustain shopkeepers’ motivations for serving young women by channeling customer feedback. This is a 24-month cluster randomized trial over 40 health catchment areas.
Thus far, after six to nine months of implementation, nearly 6700 young women have joined the Malkia Klabu loyalty club program. 141 ADDO shops have enrolled in the study, and about 15,000 HIV self-test kits have been distributed, along with thousands of contraceptives and pregnancy tests.
And our mystery client visits to intervention shops are showing that most shops are delivering intervention as intended, but we have varying degrees of youth friendliness, which we’re trying to look more into in terms of analyzing our audio recordings.
Circling back, our overarching message is that girl friendly private drug shops have the potential to vastly increase the reach of interventions for young women. But because these are private, for-profit, largely independent owned small drug shops, with finite working capital, they are going to require special attention for honing in on a sustainable business model that reaches the vulnerable, that is the key.
So looking further beyond, we need to understand what is the exit strategy above and beyond the current trials that we’re doing. How do we integrate the intervention into the existing supply chain, health system, regulatory frameworks? And I’ll close with a quote from one of our club members: Malkia Club makes girls confident when they meet boys. Thanks for your time today, and I’ll pass the mic over to Dr. Dima Qato.
Considering Pharmacy Locations and Need to Bridge “Pharmacy Deserts”
DIMA QATO: Thank you. I also don’t know if my video is showing, but I assume it is. Thanks for inviting me to speak about a topic that I’ve been working on for over a decade now, and that’s around pharmacy deserts, and specifically in how it relates to HIV care, including access to PrEP. Some disclosures here. One of the key messages here is that expanding pharmacy access to HIV prevention and treatment in black and LatinX neighborhoods is critical to ensuring equitable access to HIV medicines and reducing persistent disparities in HIV incidence.
My research program really focuses on three key areas: using research to increase awareness and advocacy, support programs, and promote evidence-based policy, all to ensure that individuals and communities have equitable access to medications regardless of where they live. And I’ll be just sharing some of the initial studies that we’ve done around pharmacy deserts and how they relate to HIV care.
So this is the first study that we published in 2014, and it really answered a question that stemmed from my dissertation a few years before publishing this, and that is what is the role of pharmacies in disparities in medication access and medication adherence.
And one question that hasn’t been answered before this study was are pharmacy deserts, or is geographic access to pharmacies a barrier to accessing medications in predominantly minority neighborhoods.
And I focused on Chicago, for a variety of reasons, including that’s where I’ve lived for many years, and it’s one of the most segregated cities in the country. And what we found was pharmacy deserts are indeed more prevalent in black and Latinx neighborhoods in Chicago, and that could potentially contribute to barriers in access to medicines.
In a follow-up study we published a few years ago we looked at the 30 most populous cities in the country, and we found similar patterns. Not only are there fewer pharmacies available or located in black and Latinx neighborhoods in these urban areas, but there are also more pharmacy deserts.
So the disparities in pharmacy access are persistent, they’re wide, and they haven’t really been reduced in the last five to ten years. So what you see here, white would be the neighborhoods that are in the light blue, towards your left, and black are lighter green, the teal.
And what we found is across all cities, at least these 30 cities, there are wide kind of gaps in terms of the prevalence of pharmacy deserts. So there are more pharmacy deserts, more people living in black neighborhoods in Chicago and Baltimore and Los Angeles that lack convenient access to pharmacies compared to more diverse or more predominantly white neighborhoods.
And that is really important, and we’ve published this in health affairs, and they had a few other studies that came. But all of this really illustrates that pharmacies are critical, we know there are about 60,000 across the country, many of them are closing, but there are disparities in pharmacy access.
So when you think about the role of pharmacies, and pharmacy-based HIV care, on delivery of PrEP or PEP services to communities, we really need to consider how do disparities in pharmacy access really impact disparities in the effectiveness of these interventions and programs that are pharmacy centered. And we saw this play out during COVID, when a lot of the testing initially was delivered through pharmacies, mostly chain pharmacies.
And what we know from our work is that chain pharmacies are less prevalent in minority neighborhoods, also in rural neighborhoods, which were the neighborhoods that were most at risk for getting COVID, and in this case also HIV. This is some preliminary work that my team is working on that builds around just pharmacy access but also just how is PrEP need met at the neighborhood level.
So we used data from patient level data on PrEP prescriptions at the zip code level, and we looked at unmet PrEP need, which we defined as PNR less than one, and this distribution by neighborhood racial/ethnic composition. And as expected, we know there’s racial/ethnic disparities in PrEP use, but this is really the first study to show unmet PrEP need, using the PrEP to need ratio at the zip code level.
And there is wide, very similar to our pharmacy desert work, and it is very parallel. But white neighborhoods, the share of white neighborhoods and EHA priority counties and cities are more likely to have a lower share of their neighborhoods that have unmet needs, whereas black and LatinX neighborhoods, a larger share of neighborhoods have unmet PrEP need.
And these are maps, just to kind of showcase again preliminary work, we’re working on sending this publication in for a grant, to showcase how neighborhoods matter with PrEP, especially when we’re trying to design programs and interventions that are pharmacy centered. So when we overlay our pharmacy desert maps for these cities and counties, there is a lot of overlap.
So it suggests that, and this is an example of Los Angeles, it suggests that many of the neighborhoods that really have unmet need may not have convenient access to pharmacies, and we need to consider that when we’re delivering care or trying to promote pharmacy-based care, and if we don’t we may unintentionally widen disparities. We have seen some of that play out with contraception, in some of our prior work, and we want to make sure that we’re cognizant of that when we implement any pharmacy centered programs.
And one last research program that a group of students at USC just finished up, that is also very important to consider given the interest in using pharmacies, which I think we should, we just need to be very careful in how they’re implemented and rolled out in communities so they ensure equity and not undermine equity.
So, in California they implemented pharmacist prescribed PrEP a few years ago, but out of the over 1500 pharmacies in LA County, and this was mystery shopper design, within three months I had four students trained, piloted, called all these pharmacies, and only 26 actually provided the service. That’s a problem. We need to know why that’s happening. I mean, there are known reasons for the slow uptake, but it’s real, and it’s current. This is just from three to six months ago.
Another issue is stock. So, pharmacy access is one, and the other is these certain products aren’t really being stocked at pharmacies as much as they should be in order to promote access to these medicines. And I think that factor is often overlooked. So we really need to consider these pharmacy access barriers when we’re trying to implement and promote access to HIV care at community pharmacies.
So I am kind of with this message, that policies focusing solely on expanding pharmacist-prescriptive authority do not address barriers in pharmacy access, including the availability of medicines, and may worsen disparities in HIV prevention and treatment. Thank you. I’ll now bring it to I think Jason. Thank you.
Questions for the Panel
JASON HATAYE: Thank you, Dr. Klepser, Mr. Shaw, Dr. Liu and Dr. Qato for four outstanding presentations. I’m going to ask each of you to turn on your camera for the discussion period. As we’re waiting for questions to come in, I would like to start off by asking one. And this question comes from the perspective of NIAID, which is where I work, we’re funding research on new methods to rapidly test HIV viral load, either for self-testing or at the point of care, such as in the pharmacy. And I would be interested in hearing from all of our panelists on how such a new technology, if it were to become available, might be applied in the pharmacy for HIV prevention and treatment.
DONALD KLEPSER: No, no, let me go first I think they would be applied in much the same way they could be applied in other settings. I think, again, if you can get to quantitative viral load, as opposed to the qualitative testing that’s being done in most pharmacy settings, that moves the needle.
That allows you to go beyond doing just screening, to something closer to, and I’ll pull it back, to potentially some form of test and treat, in monitoring effectiveness of therapy and adjusting doses, and all of the things that pharmacists are equipped to do.
Now, understanding that they have to be CLIA waived, and they have to be inexpensive, and they have to fit into a pharmacy setting and workflow. But if you provide a better tool, I’m sure somebody will find a way to use it.
JASON HATAYE: Would it be valuable enough, because there is that period of after infection, there’s acute HIV infection, which the point of care antibody tests aren’t going to cover for several weeks. Is that time, is that going to be worth it enough to try and implement something like that?
And I know in the clinical research realm, here at NIH where we have clinical trials, where people are temporarily stopping antiretroviral therapy in the context of say like a potential HIV cure intervention, those types of point of care tests would be useful. But I was just wondering, particularly in the pharmacy, I think with regard to both PrEP and treatment.
DONALD KLEPSER: You could, and this is anecdotally, but certainly we hear that what drives some portion of people in for testing is exposure, or perceived exposure. And so if you are coming in shortly after that exposure, and the current testing isn’t adequate, yes, something that could identify earlier would be valuable.
And certainly, while people are being educated and encouraged to come back, we all know that may not happen. I think on the testing and treatment side, absolutely. And I would probably extend that on the PrEP side as well. Even if somebody is coming in quarterly, you would potentially miss three months.
JASON HATAYE: Dr. Klepser, let me ask you a question about your presentation. Your team diagnosed about six persons with HIV. So, of these six cases, is there any information that you have on whether they started ART and then suppressed HIV replication? And then after you answer that specific question, I would want to open it up to the rest of the panel to discuss how pharmacies can connect the patient with an HIV positive test to starting on ART and then primary HIV care.
DONALD KLEPSER: So I would say that was a limitation of that study, in that it was really aimed to get people to follow up care, to confirmatory testing. And I can say that all of those patients did get, for confirmatory testing. But the way we had structured it, we weren’t able to follow those patients through.
Recognizing that we had a fantastic follow-up study put together, and then COVID happened and people just quit testing in pharmacies all together, at least in our setting. So we lost that ability to follow the patients. But I think that is high need, that those patients are followed and that we can show that it is ultimately leading to viral load suppression.
JASON HATAYE: I want to open it up to the other panelists to talk about sort of the warm handoff between testing positive and initiating antiretroviral therapy.
DIMA QATO: I can speak a little bit to that. I think it is important to one, maintain continuity I think that was mentioned, discontinuity of care is a problem, including in pharmacies. So for a positive HIV result we want to make sure that there is that relationship not only with the patient but also with local prescribers to refer patients. That’s one. I mean, that’s like theoretically, right? But how about insurance, how about access to care coverage?
So depending on where you sit, if it’s an FQHC, or if it’s a clinic, or a community pharmacy that’s not out of network, there’s all these kind of system level barriers I think that come into play in the real world that are important to consider as you implement the program.
Because if you have a relationship with certain prescribers, maybe patients may not be able to use them. So I think always really being patient centered and making sure that whatever referrals you have are aligned with where the patient is interested in going, especially for HIV care.
DREXEL SHAW: I would agree with every panelist there that continuity of care is extremely important, and then also from someone that used to work within the local health department systems, I would say the health departments play an important role in the linkage to care process. Oftentimes it’s overlooked.
And I would say that just ensuring that pharmacies have a strong relationship with their local city health department, which has really dedicated resources that are trained to be able to support that linkage to care process.
And I always try to say when we think about pharmacists, and pharmacies in general, we are part of that linkage to care process, but we are not the whole process, and there is a team of medical professionals, we work as a team together.
And so initially testing, even if it’s done by a pharmacist, that linkage to care process I think doesn’t necessarily have to be done by that pharmacist or a pharma tech, it can be done by somebody, particularly a navigator at a local health department, which typically as I mentioned you have a strong understanding of finding a pathway for care for a person regardless of if they have insurance or not, and so it helps overcome some of those barriers and give them rapid start to ARTs.
JENNY LIU: Thanks for your question. I am happy to answer this question from the perspective of Rural Tanzania, which I think is a very different setting than where all of the rest of you are working.
In Rural Tanzania, these little, small drug shops are not really connected to the larger health system. And unfortunately, the legacy is that they are working in sort of suspect of one another, and in isolation of the public health system.
Now, that being said, there is a missed opportunity here. Clearly, everyone is working towards the same goal. And what we found is that oftentimes part of the problem is that adolescent girls in our context are afraid to go to the public health clinics because they are treated poorly, number one, two, they’re fearful of running into somebody that they may know, and there’s a privacy aspect there.
And two, they’re just hard to get to, potentially. And once you get there there are long lines, and you don’t want to be waiting around, you want to be sort of incognito, wearing a wig and sunglasses and trying to hide.
So, one of the things that we did in our human centered design process, thinking about what the solution needs to incorporate, was this access of what is an effective referral, what is the most likely configuration of things that we can put together to help make that person who screens positive likely to go to the public health clinic, which they didn’t want to go to in the first place, and get back that confirmatory test.
So in our trial right now what we’re doing is we found that having specific referral information, not just go to clinic whatever over there, having specific referral information that says please call your personalized referral counselor, named so and so, Janet, and here’s her number. You can also contact a peer navigator. So we have a one-on-one peer navigator who is already connected to the local public health clinic to help young people get connected to services.
And so this is basically our solution to a concierge service. And so the peer navigator in concert with the referral counselor, they’re kind of the linkage in the lifeline that is both personalized, and for the most part as private as we can get it.
So, records show that this seems to be working, but I will come back to you in about a year and let you know the final results.
JASON HATAYE: Great. Some questions are coming in. And so I will start with one from Gregory Hong(ph). We hear about closures of community pharmacies across the country, especially with the rise of, it says sinkage but I’m not sure what that is, but the rise of sinkage, that’s what it says, what are the panelist’s thoughts on how this impacts HIV treatment and prevention? Any way to address? Okay, with the rise of theft.
DIMA QATO: I can take a stab at that. I’ve done a lot of work on closures, pharmacy closures. The short answer, whatever the cause, the cause isn’t theft necessarily, that could be a cause for some, but that’s not necessarily a cause for all closures. And it’s more related to reimbursement, PBMs. So that said, of course it’s going to impact access to HIV treatment and prevention.
If you’re going to a pharmacy and it closes, we’ve done studies on that, I didn’t share them today, but when pharmacies close, people, many of them, especially when they live in pharmacy deserts, stop going to the pharmacy to fill their medications. If they can’t fill their medications, they can’t get tested, they can’t get the pharmacy services they used to receive when the pharmacy was open. But again, that depends on where the pharmacy is closing. If there’s a pharmacy closing, there’s another one next door, the impact we found wasn’t really substantial.
However, if you have a pharmacy that you go to and it’s kind of the only pharmacy within a few miles, that really will impact access to HIV treatment and prevention. So it’s a serious problem, especially as pharmacy closures are increasing, our planned closures are going to increase in the next few years.
JASON HATAYE: Dr. Qato, you showed us that there are pharmacy deserts in urban settings, such as Chicago and Los Angeles. Those neighborhoods where there are two or three pharmacies in easy walking distance of one another, and sometimes there’s one pharmacy in the neighborhood, how does your analysis of pharmacy deserts account for the huge difference between at least one pharmacy per certain number of census tracts, versus zero, because the difference between zero pharmacies and one pharmacy is so much more practically significant than the mathematical difference between one and two might suggest.
DIMA QATO: That is a good question. The way we measured it is using geographic distance. So it’s at the neighborhood census tract, actually derived from block group level. So we looked at the distance to the nearest pharmacy.
So every tract had a measure of distance, it could be 20 miles, it could be five, it could be 0.5. So we measured distance to the nearest pharmacy. We had two measures, one is availability, which is the number of pharmacies per tract, which is I think what you’re referring to.
The other is the pharmacy desert definition, which is a measure of geographic access based on distance as well as poverty level and vehicle ownership. And using half a mile, one mile threshold, we define a neighborhood as a pharmacy desert, based on whether it was low income, or if most households didn’t own their own car.
But some pharmacy deserts are better off than others. So we didn’t do that differentiation. But the only differentiation we had was one mile versus half a mile in urban areas, but we have other studies that looked at suburban and rural.
JASON HATAYE: A question came in from Pia Morton. She is in a therapeutics research program at the Division of AIDS. And this question is for Jenny Liu. What role can behavioral scientists play in developing HIV service programs for special populations?
JENNY LIU: Thanks, Pia. Thanks for your question. I’m so happy you asked this because this is sort of what I live and breathe. We are really trying to I think at the forefront trying to develop programs that are person centered. And what does that mean? It’s not just the users, the populations at risk, but also the service providers who need to provide the service in a way that is also empathetic and understanding of the patient’s needs.
And so in that way this is kind of where we need to align the motivations and incentives, not just monetary, but also non-monetary, at the point of intersection between the patient and the provider, and understanding that both come at this one interaction, which is a moment in time, but both come to it from a journey, and anything along that journey, any hiccup can sort of derail you from the optimal behavior.
So think about like you see traffic on the road, oh you’re not going to run that one errand that you had planned today. Small things like this build up along the entire journey and sort of give you lots of excuses not to be your best.
And so that’s really where we need to focus, not just a single point in time, but how people come to this point in time, how do we unpack all of the pieces and points of pain that people experience along that journey, and then figure out where the different sort of small interventions may be where we can sort of right that turn that we were supposed to take and set you off on that journey.
That’s kind of how I look at the problems that we want to understand this holistic experience and not just think about dropping the commodities off from a plane and magically things will happen. We know that that is time and time again not the case, just because you build it doesn’t mean people will come.
So we need to figure out how to help people be their best, for both users and providers, and for vulnerable populations we know that they are sitting at the intersection of multiple vulnerabilities. They’re financially disempowered, they’re socially disempowered, and they’re emotionally fragile.
And so to really understand what are all the supports they need to get to where they need to be, and take up these services, that’s where I think a lot of the behavioral innovations need to go in our next generation of interventions.
JASON HATAYE: I wanted to ask Maria to rephrase your question, please. And then asking a question from Diana Fendsy(ph). Do panelists have thoughts about making these proposed strategies attractive to the providers in terms of profits for the pharmacies? And this will have to be the last question, actually. I’m sorry.
DONALD KLEPSER: I will take a stab at it. There was another question in there about why did people shift to COVID testing during the pandemic and move away from HIV testing or other services. Yes, any time there is profit, any time there is economic motivation it’s going to become more appealing.
If there are ways that we can make this economically feasible, sustainable, profitable, whatever term you want to use, for the provider for the pharmacy, the more likely they are to be to do this. So it starts with fair reimbursement rates, it starts with access. And not just fair reimbursement, but an easy process for getting there. Drexel, I see you nodding along. If there were unlimited money flowing in, we wouldn’t be having this conversation, everyone would be doing it.
JASON HATAYE: I would like to thank our panelists, and audience, for a nice discussion. And I’ll now turn it over to Paul Gaist.
PAUL GAIST: Thank you very much. This is bringing us to the conclusion of day one. And I would like to really just say it has been a dynamic first day, and I would like to thank all of our day one speakers and moderators. As I had previously made note, the incoming questions and comments have been on the mark, and often prelude to content and comments that followed through the day. So also a thank you to all the media attendees for your participation as well, including for answering the poll questions.
Tomorrow we will begin again at 1:00 PM, and there will be several panels. Topics, advancing HIV PrEP through pharmacies and pharmacists, advancing HIV treatment through pharmacies and pharmacists, addressing HIV syndemic factors and comorbidities through pharmacies and pharmacists. A lot about pharmacies and pharmacists, imagine. With a closing session and meeting report out, as well as concluding remarks.
To note, we had one SNAFU today with the meeting’s email address. We’re working on that, and we hope to have that worked out for tomorrow, so stay tuned. On that note, we hope to see you again at 1:00 PM tomorrow to continue this very important discussion focused on pharmacy centered HIV research, including exploration of our current landscape as well as future frontiers. See you tomorrow.