Day 2 - Pharmacy-Centered HIV Research: Current Landscape and Future Frontiers
Day Two Welcome
Reminder of Research Gap Idea Generation
Introduction of Panel Three Moderator
MICHAEL STIRRATT: Excellent. Thank you so much, Amy. Welcome, everybody. Welcome to day two of our NIH sponsored meeting on Pharmacy-Centered HIV Research: Current Landscape and Future Frontiers. I’m Mike Stirratt from the NIMH Division of AIDS Research. Thank you for being here. Here at NIMH, we are delighted to partner with the NIH Office of AIDS Research and many other NIH institutes, centers, and offices on this important meeting. I’m sending a special note of thanks to our planning committee, which includes representatives of 10 NIH institutes, centers, and offices for their involvement in planning our agenda. Thank you.
Our agenda for this meeting has been rich and exciting. We do have our meeting agenda available for download now. We were able to repair an issue with our meeting website, so I’ll ask our planners to put the link to the meeting website in the chat. At that link you can download the meeting agenda, as well as a document that lists the bios for our speakers. On day one, for those of you who are here, we had an electric opening session with speakers like Harold Phillips from the White House, Michael Hogue from the American Pharmacists Association, and Rear Admiral Kelly Battese from the U.S. Public Health Service, Paul Weidle from the CDC, all of whom were talking about the many important contributions that pharmacists can make to our efforts in HIV.
We also heard researchers like Dr. Natalie Crawford and Katrina Ortblad talk about how promising the research evidence is on pharmacy-centered HIV service delivery. We were able to consider what pharmacies can do both from independent, community independent pharmacies, as well as community chain pharmacies on our second panel yesterday, along with the need to meet important community needs in the course of our efforts through these venues. We concluded yesterday with a panel that talked about promoting HIV testing, how we can advance HIV testing through pharmacies and pharmacists.
Today on day two, we’ll continue to drive through the many different fronts that pharmacists and pharmacies can help us with in HIV. We’ll begin with a panel on HIV PrEP and then we move to a panel around supporting HIV treatment and then we conclude with a panel on addressing syndemic factors and comorbidities through pharmacies and pharmacists. Finally, today we will have a closing session looking to the future. That will be a chance for us to have a rapid tour session where we’ll talk a little bit about the opportunities and the challenges that we’ve covered and how we could program our future research efforts on this front.
Let me now go ahead and just remind you that, in addition to having the terrific presentations, the discussions at this meeting, we do want to very directly invite your input on future research directions in this space. We have this important question we’ve posed. Our question is, what research is needed to further advance pharmacy-centered HIV service delivery? If you were with us yesterday and you tried to do this, you’ll know that we did have a little bit of a problem with our email. Here we have a fresh email, an email that works. It’s a little less descriptive.
It’s email@example.com. DAR actually refers to Division of AIDS Research. If you’re willing to send a short response, a short reply, doesn’t have to be long to firstname.lastname@example.org, a response to our question about what research is needed to further advance pharmacy-centered HIV service delivery, we’ll record your response and that will help us to inform our next steps. Thank you for being willing to do that.
Now it is time for us to turn to our first panel. I’m very excited to pass to Jeremiah Johnson, who’s long been a trailblazing advocate in HIV. Jeremiah, I pass the meeting to you.
JEREMIAH JOHNSON: Thank you so much, Michael. It’s a pleasure to join everybody. Thank you for the introduction. My name’s Jeremiah Johnson. I am the Executive Director at PrEP4All. We are a nonprofit think tank working on equitable access to PrEP for everyone who can use it. I also like to bring into these spaces when I’m invited that I am someone living with HIV myself. While lived experience is not everything in the conversation, it is a necessary part of the conversation. I’m pleased to be here.
I’m excited to continue with this innovative conversation. As we know, the status quo for PrEP access is not working in the United States. Recent CDC statistics are showing that we’re getting PrEP to maybe 78 percent of the White individuals who could most benefit from it, but only 11 percent of the Black and African American individuals, only 21 percent of Latinx individuals. This conversation is great because it is breaking us out of where we’ve been. There’s tremendous potential in pharmacy delivered PrEP. As we discussed yesterday, and as I think we’ll get into more today, simply addressing scope of practice is not a silver bullet.
A number of challenges and considerations came up yesterday. I’ll say a bit about reimbursement for pharmacists in terms of providing care. Raising community awareness of pharmacies as areas of access. Training and education for pharmacists. Making sure that medications are stocked at pharmacies. We still have many questions and many best practices to determine.
Also, I’ve been struck by how much of this conversation has been about insured individuals. If we’re truly going to discuss this in terms of equity, I’m curious how we see this discussion benefitting the 30 million plus individuals who are still uninsured in America, the millions who are still underinsured who are disproportionately Black, Brown, and trans. Including how we can address PrEP access outside of 340B funding situations.
I believe that part of why Mike asked me to come and moderate the panel is because of our work on a national PrEP program for un- and underinsured individuals. This conversation in many ways feels like an important subset of that broader conversation. In case you haven’t heard about the movement for national PrEP right now, there really is a national movement for a national PrEP program. It has been represented in the President’s budget requests for the past two years. We have congressional champions, a national coalition of hundreds of organizations, thousands of individuals signed on in support of a national PrEP program.
As this conversation evolves, we continue to hear more about how additional infrastructure and additional resources importantly can probably bolster and support these efforts for pharmacy delivered PrEP. I’m eager to see those conversations intertwine and see how all of that comes together and encourage everyone who’s involved in this conversation to pay attention to the conversation for a national PrEP program and see how you can get involved. All of this is related and many of the topics that we’re discussing here today are also related to that conversation.
Without further ado, I’m going to introduce who we’re going to be hearing from today. I’m going to pass it off to our first presenter. I’m honored to be joined by Heidi Wood from the University of Iowa Healthcare, Mariano Kanamori from the University of Miami Miller School of Medicine, and Drexel Shaw who we also heard from yesterday from CVS Health. Raiza Beltran from UCLA Luskin School of Public Affairs and Tam Phan from the USC Mann School of Pharmacy. Alex Dubov from Loma Linda University and Jillian Pintye from the University of Washington. All joining us to take us through a geographic journey about PrEP initiatives in pharmacies all over the U.S. and around the world.
Just a few reminders. If you want to read more about all of our presenters, Janelle has put the link into the chat with more information on people’s bios that you can check out. As we all keep reminding you, please use the Q&A function to offer up any of your questions. At the end of the panel we will have 20 minutes to try to address as many of those questions as possible. Without further ado, I’m going to invite Heidi Wood to come on camera and kick us off with the first presentation.
The Iowa TelePrEP Program: Telemedicine + Pharmacists = PrEP Access and Use
HEIDI WOOD: Thank you, Jeremiah. Today I’m going to talk about the Iowa TelePrEP Program and how telemedicine plus pharmacists equals PrEP access and use. I have no conflicts of interest to disclose. My main message today is that the Iowa TelePrEP Program overcomes distance and stigma barriers to provide PrEP in Iowa. The state of Iowa is mainly rural communities, and there is concern about providers who can provide PrEP to people being within a reachable distance. There’s also concern that when somebody presents to a clinic or a pharmacy in their community, more than likely they know one or more people working at those locations and there may be stigma or concerns about making them aware that they’re using PrEP.
The Iowa TelePrEP Program is really more than just telehealth. There are three main components to the program. Yes, telehealth, the technology to have video and phone visits with people across the state is very important, but other major aspects are a strong collaboration between our Iowa Department of Public Health and the University of Iowa Healthcare Health System. Finally, pharmacists practicing under collaborative practice agreements to provide the care. The TelePrEP Program began in 2017 with a grant through the Iowa Department of Public Health and then further grew through CDC Demonstration Project grants.
I’m going to take a minute to give a high-level overview of our program. For the Iowa TelePrEP model, my left-hand side, there are three major avenues that we receive referrals for people who may benefit from PrEP. First, we have our public health referral. This really comes from the statewide network of local sexual health and STI clinics and programs across the state. Second, word of mouth is a major source.
Also, social sexual networking sites such as Grindr or digital advertising has identified people who are interested and may benefit. Finally, referrals from HIV clinics across the state, referring partners of people receiving care in HIV clinics. Also, local providers across the state who may have patients interested in PrEP, but the providers may not be interested in monitoring or providing PrEP on a larger scale.
All of these referrals are funneled to the state of Iowa PrEP navigator, Seth Owens, who plays a major role in the program. Seth works very diligently with anybody who shows interest through texting, phone calls, and what might be to provide education answer questions, identify barriers and how to come over them, and then dealing with different insurance issues. Then together, he and the interested party work to decide what area to receive PrEP from is best for them. For people referred to our Iowa TelePrEP Program, it begins with an initial video or telephone visit with a pharmacist, such as myself.
From the initial visit, if a person is interested in receiving PrEP, then it becomes a continuous loop of getting labs at local labs near to them. Very often, it’s in partnership with our public health sites, may also be local private labs. Then medications we get to people all over the state by shipping. We have the UI specialty pharmacy that can deliver medications to people across the state for no charge of shipping. Or other local pharmacies per person’s preference or if it’s required by insurance. One thing I do want to bring up that may come later is that all of the visits with the pharmacists are free of charge to anybody. We want to make sure that these services are accessible no matter of somebody’s insurance status.
This shows the navigation outcomes for the first approximately 1300 people referred in the state of Iowa. For the referral source of the pie graph on the left-hand side, two-thirds of people were referred by either public health or self-referral. On the right-hand side, the navigation outcomes. Approximately 50 percent were referred to our Iowa TelePrEP Program. Other outcomes were either people could not be contacted, declined, maybe they just were interested in education about PrEP. Approximately seven percent received PrEP through a community provider.
This shows demographics of the first 500 people receiving PrEP through the Iowa TelePrEP Program. A few things that I do want to point out. The average age of the person receiving PrEP was 32 years of age. Majority were cisgender men who were involved in MSM encounters. As far as race, it really reflects the demographics for the state of Iowa. Majority of people identify as white. For Black or African American people in Iowa, it was 10 percent of the people making up our Iowa TelePrEP Program, while only 4.3 percent of the people in the state of Iowa identify as Black or African American. Also, for Latinx islands make up the population of 6.7 percent of the state of Iowa, but represent 11 percent of people receiving PrEP through Iowa TelePrEP.
As far as residents, as you can see, majority of people are either located in rural areas or very small urban areas that may not have great access to nearby healthcare. Interestingly enough, when you look at people engaged in healthcare otherwise at the bottom of the graph, for people followed by a local PCP, only about 50 percent of people are engaged in healthcare outside of the Iowa TelePrEP Program, which shows the collaboration and networking to connect with our Iowa Department of Public Health to reach people.
Finally, a couple of statistics I wanted to point out. We’ve been able to demonstrate a high quality of care that we really have attributed to pharmacists practicing under collaborative care. For guideline-indicated lab monitoring, there was a 94 percent completion rate. This compares to 70 to 80 percent completion rate for guideline-indicated lab monitoring in PrEP clinics in the typical brick and mortar building. Of clients surveyed, 97 percent were completely or very satisfied with the service. For people that started PrEP with Iowa TelePrEP Program, 84 percent were retained in service at six months.
Another important thing to point out is this model has been sustainable. It began as a CDC Demonstration Project, but that ended in 2021. The program has been able to continue because of a strong collaboration between public health and our healthcare system and also by support through 340B cost-savings. Although, as many people have alluded to, those are decreasing with time.
Finally, I want to close with benefits of the program and opportunities moving forward. Benefits that have been able to be demonstrated. This is a sustainable model of care. We’ve been able to reach people who are geographically dispersed, may not be near local healthcare providers offering PrEP, or reaching people that need to overcome potential stigma and privacy barriers within their own communities. We’ve been able to demonstrate a high quality of care and been able to really reach populations reflective within the state demographics.
For opportunities, as alluded to yesterday, injectable PrEP, that’s something that we are still trying to develop standard models to be able to provide on a large-scale basis. We do have nPEP services, but we want to continue to expand our reach and provide more of that. Then we’re also interested in expanding other clinical opportunities and services, such as buprenorphine, hepatitis C treatment, and others as they come along.
With that, I’m going to close. Thank you for your time. I’m going to introduce co-presenters, Mariono and Drexel. Thank you.
A Novel Community-Retail Pharmacy Partnership to Advance HIV PrEP Among Latino Men in Miami
MARIANO KANAMORI: Thank you, Heidi. I am Mariano Kanamori from the University of Miami Miller School of Medicine. Joining me today is Drexel Shaw from CVS Health. We are very pleased to be able to describe our partnership and innovative approaches that we are using to increase PrEP initiation by South Florida Latinx. We have no conflicts of interest to report and are grateful to acknowledge funding from NIMH and NIAID.
DREXEL SHAW: Thank you, Dr. Kanamori. Hello, everyone. Drexel Shaw, CVS National HIV/Sexual Health Liaison. To kickoff, I would like just to say it’s an honor to be with you today, to see this is committed to advancing health equity for colleagues, consumers, and communities by really improving the trust, the access, and quality of health for our historically marginalized communities. We’ve increased our investments in programs that address, that are addressing, barriers to care and to help alleviate those inequities and disparities for communities historically affected by HIV.
One in particular is around the Black and Latinx/Hispanic community. Those overarching goals are centered around increasing awareness and access to HIV testing and other prevention modalities like PrEP. Second, share educational resources for persons newly diagnosed with HIV or initiating PrEP therapy. Lastly, finding ways to support the Ending the HIV Epidemic Initiative.
When we look at this slide particularly, I want to take us back to 2018 when we started collaborating with the University of Miami, focusing in the South Florida region, particularly in the Latinx community. With the intent to develop innovative behavioral research approach, we’ve been really focused on forming, linking, and retaining South Florida Latinx community in and around HIV prevention, such as PrEP and HIV testing.
Through so many amazing observations, implementations, projects at these alternative, local CVS pharmacy retail stores called Y Mas or Navarro pharmacies, we’ve garnered many amazing insights into how pharmacies can raise awareness of HIV and take action. With 85 percent of the U.S. population living less than 10 miles from CVS pharmacies, the CVS and the University of Miami model, developed with funding from NIH, has the potential to scale-up to a national level. These pharmacies have the presence to expand and reach the Latinx communities who may benefit from PrEP.
Lastly, I’d like to encourage industry and for us to continue to collaborate with academic institutions, as we’ve been able to garner amazing insights through this collaboration with the University of Miami to innovate, address health inequities and disparities in communities impacted by HIV, which will improve the trajectory of health for everyone. With that, I’ll turn the remainder of this portion back to Dr. Kanamori.
MARIANO KANAMORI: Thank you, Drexel. I will now briefly describe three of our projects. Project One was an EHE bilocal study that included a pharmacy chain base network. It also included three other networks: social and friendship, community radio, and parks network. For the pharmacy component, CVS Health and my lab at the University of Miami developed culturally tailored materials, including posters and over 14,000 flyers. This material displayed PrEP information and services offered at our community partner, Latinos SALUD. They were distributed at seven CVS Health venues in Miami. You can see the number of clients served by Latinos SALUD in 2022.
Project Two was a hybrid 1 implementation-effectiveness randomized controlled trial of an implementation strategy bundle of a social network support and one-stop-shop PrEP services to improve PrEP initiation of Latinx MSM. We are just starting this RO1 study. At CVS Health venues allow us to reach Latinx males who are not engaged in gay events and generally have low PrEP awareness. In a preliminary study, we have developed a social network model that allows us to engage 130 Latinx PrEP candidates using only 10 seeds.
Project Three is our proposed next step together. CVS Health and my lab are developing a new PrEP implementation sign up program that will leverage pharmacy chain-based services to help Latinx learn about PrEP, decide if PrEP is relevant for their lives, access PrEP, and sustain PrEP use. Our proposed program will address the need for new approaches that increase PrEP initiation by Latinx MSM and women at higher risk of contracting HIV through bisexual or non-monogamous partners.
We would also like to share our partnership characteristics that we believe have been important to our success. First, we support community-based participatory research. Second, we are willing to invest in, develop and maintain a long-term partnership. Third, we recognize and respect diversity in our community. Fourth, we have sensitive listening skills and strive to learn from each other. Finally, we recognize the importance of communication, joint decision making and project timelines.
Thank you. Next, we will hear from Raiza Beltran and Tam Phan.
Understanding the implementation of SB 159: Pharmacist delivered pre- and post-exposure prophylaxis in three high EHE counties in California
RAIZA BELTRAN: Thank you for having us speak today regarding our research project on Understanding the implementation of SB159: Pharmacist delivered pre- and post-exposure prophylaxis in three high-priority EHE counties in California. My colleague, Tam, and I are presenting our work on behalf of our study team and coalition partners.
TAM PHAN: Thank you, Dr. Beltran. Good morning, everyone. Thank you for being here. My name’s Tam and I’m one of the co-investigators of the study and clinical pharmacist at the Los Angeles LGBT Center. We, the speakers, have no conflicts of interest to disclose. Our key message for today’s presentation is that while SB159, and similar legislations, empower pharmacists to provide PrEP and PEP, challenges in awareness, workflow integration, and reimbursement persist.
With the first product approved in 2012 and the several products and dosing strategies thereafter, there have been significant clinical effectiveness of PrEP at preventing HIV. However, significant disparities exist in PrEP uptake and utilization. While there’s an estimated 1.2 million Americans in the United States are likely to benefit from PrEP, CDC data approximated that only about a quarter of these patients are eligible for PrEP were actually prescribed. Additionally, we also see that there are significant disparities in terms of PrEP coverage based on race and/or ethnicity.
An additional factor to consider is provider capacity. While the number of PrEP providers has increased significantly over the past few years, there are still many challenges and areas where access to PrEP is limited due to a shortage of healthcare providers. This is particularly true in rural and underserved areas, where there may be fewer healthcare resources available. Despite these challenges, PrEP remain a critical tool in the fight against HIV and improving access to uptake of PrEP is a crucial goal for healthcare providers, policymakers, and communities.
Given that nearly 90 percent of the U.S. population lives within a five-mile radius of a pharmacy, and pharmacists' scope of practice continues to expand, pharmacists will play a vital role in increasing PrEP access. In California, the opportunity for pharmacists’ involvement in PrEP was identified, and in 2019, SB159 was passed, which permits pharmacists to independently furnish PrEP and PEP in a limited amount. Since then, several other states, currently counting at 13, have passed similar legislations to increase access to PrEP. Recently, the UC Berkeley’s School of Public Health surveyed over 900 California pharmacists, and 96 percent of the respondents felt that a pharmacy-based PEP and PrEP provision is vital.
Yet 11 percent of the surveyed respondents had implemented this service. Seen here is the breakdown of responses specific to Los Angeles County and the Inland Empire, which are considered high priority areas for California in the EHE initiative. While there are similar responses across these domains, there is a difference between the willingness and importance of PrEP, compared to one’s confidence and knowledge of PrEP. While California was the first state to pass this legislation, implementation of pharmacist-initiated PrEP have been low due to several factors. I hope our project can elucidate and address implementation barriers to increase access to care. I will now pass the mic to Dr. Raiza Beltran.
RAIZA BELTRAN: Our study was one of the 25 projects funded across the U.S. by the Centers for AIDS Research under the National Institutes of Health. We were seeking to understand local implementation determinants in pharmacist-delivered PrEP and PEP, with a focus on PrEP deserts in three Southern California counties– Los Angeles, San Bernardino and Riverside counties. Our main intervention is pharmacist-delivered PrEP and PEP and we want to understand the barriers and facilitators to these services among pharmacists and community members.
This is a community-engagement specific grant, and so for our second objective, we also are focused on building local coalitions made up of various sectors working toward HIV prevention. These would include public health officials, policymakers, pharmacists, community-based organizations, and community members with lived experiences.
For this study, we have a mixed methods approach. For Aim 1, we are convening monthly meetings and presenters from different sectors of the coalition to share their work in HIV prevention. We also are conducting interviews with our coalition partners to learn their thoughts on pharmacist-delivered PrEP and PEP. For Aim 2, we will be sending out a survey to pharmacists and community members to better understand the challenges to HIV service provision and receipt faced by these groups.
For Aim 3, we seek to generate local solutions to improve implementation. For example, our coalition recently had a discussion with the L.A. County Public Health Department, and we realized that the Department didn’t know which pharmacies prescribed PrEP in the area. With the help of our coalition partners, we are now building a list of pharmacies already furnishing PrEP to provide to the County Health Department.
TAM PHAN: To date, we have facilitated four coalition meetings, with participants ranging from practitioners, administrators, representatives from the Department of Public Health, and other community members. Preliminary data from our coalition meeting have shed light on several factors that may influence the implementation of SB159. I have broadly categorized them to three pillars in terms of awareness, pharmacy-related factors, and the actual clinical service.
In terms of awareness, many patients are still not aware or do not perceive pharmacists and pharmacies as resources and access points to PrEP. In turn, many pharmacists see no demand to add on this additional service. Second, while it is appealing for pharmacists to expand their scope, competing priorities with current workflow, i.e., dispensing, immunizations and other clinical services, and the lack of a standardized protocol may deter pharmacies from implementing this service.
Lastly, a recurring theme throughout our coalition meetings have focused on the sustainability of this service as a business model. HIV screening supplies can be costly, but more importantly, this clinical service is not being reimbursed through insurances or other payers, leading pharmacy administrators to prioritize services that are non-revenue-depleting.
RAIZA BELTRAN: Here are lessons learned and some next steps. We continue to build and strengthen our local coalition through monthly meetings. We’re conducting interviews and will start to survey community members on challenges in implementing and receipt of HIV prevention services. We are also generating local solutions already. We plan to establish an implementation protocol for HIV service provision in pharmacies. We hope to build an awareness campaign by collaborating with our public health departments and community leaders to increase demand for these services. We are planning to bridge, and hope to bridge, pharmacists to local resources and community partners.
We also need to build a better business model for pharmacists seeking to prescribe PrEP and PEP. What we’ve learned is that the model of providing these HIV services in pharmacies is not sustainable, as Tam mentioned, but pharmacists do it because they see the need in their communities. Finally, for the larger pharmacies, including retail and chain pharmacies, there needs to be administrative support and implementation champions within the company structure. There are challenges, but also great opportunities in helping implement pharmacy-delivered PrEP and PEP. If you are a pharmacist practicing in Southern California, please reach out to Tam and I if you are interested in being a part of our coalition.
On behalf of our study team and coalition partners, we thank you. I’m happy to turn you over to our colleague at Loma Linda University, Dr. Alex Dubov.
A demonstration project to advance HIV PrEP delivery through pharmacies
ALEX DUBOV: Thank you. I’ll continue the conversation about implementation of HIV prevention, screening, and harm reduction in pharmacy. It’s a project that we got recently funded for by the National Association of Chain Drug Store Foundation. I wanted to quickly acknowledge, while I have no financial conflicts of interest to disclose, I wanted to acknowledge the previous work that helped us with the current grant and what I’ll describe further.
I received funding from NIMH to protest the concept that we use pharmacies in emergency department Loma Linda where we used their in-house self-screening tool and eNavigation component. Also, we trained community health workers to serve as PrEP medicators and HIV test counselors. The same work also was funded and was demonstrated effectiveness in ATN CARES project with Dr. Swedeman from UCLA CHIPTS. Dr. Swedeman is a collaborator on these two other projects. We, Loma Linda, received HRSA funding to train 200 community health workers, some of them working with us on these projects. We have unique partnerships that help us to move this work further between UCLA CHIPTS, Inland Empire Health Plan, and our university.
I wanted to describe the area that we serve. Inland Empire is comprised of two EHE priority counties, San Bernadino and Riverside. These two counties span a territory larger than 10 U.S. states, with population exceeding 27 U.S. states. It is also a HRSA designated Medically Underserved Area and Health Professional Shortage area. It’s also one of the most ethnically diverse areas in the nation with 54 percent of the population defined as Latinx, versus 39 in California as a state. Nine percent is Black or African American versus 6.5 percent of California.
The HIV epidemic profile, you can see from the slides, we have 14,000 people living with HIV in the area. 18 percent of infections are undiagnosed and in the last five years, there was a 23 percent increase in incident HIV cases, with 79 percent of the new diagnoses among non-White individuals. There’s also a high substance use rate in the Inland Empire. Inland Empire is known, or called, the methamphetamine capitol of the U.S. Public health authorities say that one in three new HIV diagnoses can be traced to or linked to substance use in one way or another.
There’s a need to increase PrEP delivery in pharmacies in Inland Empire to improve PrEP uptake among Black and Latinx Inland Empire residents. A lot of current PrEP models, pharmacy-based PrEP models are not tailored necessarily to these communities. PrEP to need ratio for Black and Latino Inland Empire residents, less than a third compared to White residents, while HIV incidence rate among Black Inland Empire residents is four times higher than those of White residents.
There are demonstrated PrEP disparities among Medicaid beneficiaries in California and in Inland Empire, highlighting the needs to address non-insurance factors like medical mistrust, stigma, and inconvenient clinic locations. It’s been said earlier in this seminar that 90 percent of U.S. population and Inland Empire residents live within five miles of a pharmacy. Pharmacists have flexible hours and serve as an ideal way to increase PrEP uptake in communities that are- there’s not accessible PrEP otherwise. We only have seven clinics not providing PrEP in San Bernadino County and 18 in Riverside County. Pharmacy PrEP models often lack tailoring to Black and Latino populations and often not coordinate substances-related to HIV risk and face financial sustainability challenges.
We received funding from the National Association of Chain Drug Stores Foundation. Their mission is to help people improve their health and quality of life through education and ground-breaking research. The project objective that we provided for is to improve HIV screening, PrEP, and relevant wraparound interventions through community pharmacies, with a particular focus on reaching vulnerable, at-risk populations in Inland Empire. It’s a three-year research grant.
Earlier presentations described multiple barriers to PrEP implementation in pharmacies, including issues with financial sustainability and payment for pharmacist’s services, refill limitations, difficulty connecting patients to follow-up care, inadequate staff and time to set up services, privacy and comfort in discussing HIV risk with clients, and point of care in HIV testing. The project that we’re currently working on is tailored to address some of these barriers.
We partnered with Inland Empire Health Plan, the largest Medicare/Medicaid, nonprofit Medicare/Medicaid provider in the United States. We’re working on developing sustainable practices for pharmacies, including finding new mechanisms and ways to compensate pharmacies for services provided. We’re also trying to address the barrier with reference to follow-up care by relying and training community health workers to provide remote assistance in navigation and linkage to care based on strength-based model tested intervention.
We’re using mHealth self-screening tool, a tablet-based tool, that helps clients to self-screen for behavioral eligibility for PrEP. Potentially a decrease in discomfort in discussing, and privacy and stigma, in discussing HIV risk and substance use risk. It also allows us to coordinate both substance use and HIV risk together. We provide assistance and training to set up point-of-care HIV testing and counseling and we have six independent and eight chain pharmacies that are working together with us.
The intervention that we developed and are working on includes the tablet-based self-screen tool set up in pharmacies to set up our plans to self-screen privately and discreetly for behavioral eligibility. This tool is also accessible, not in pharmacies, but providers. It’s linked to an eNavigation component so people will even, before coming to pharmacies, they can also self-screen and be followed-up with a community health worker who will set up, help set up, appointments and lead them through the process of obtaining PrEP.
When a pharmacy, when clients in pharmacy self-screen, a pharmacist will see their scores and discuss potential eligibility and recommend PrEP, will educate them on HIV testing, PrEP, mPox, and harm reduction. We then provide rapid point-of-care HIV testing and counseling. Same-day PrEP initiation. Eligible customers also offered mPox vaccination and harm reduction kits, for those who use the substances related to HIV risk.
Then we allow eNavigation component and community health workers to assist with insurance-related questions and referrals and set up follow-up care and link people to care. That’s the model we’re currently developing and will be pilot testing.
The overall goals and objectives for this work is to assess feasibility and compatibility of this model with pharmacy systems. Screen up to 600 patients; target for PrEP initiation is 100 patients at least. We’ll want to train and prepare pharmacists to provide relevant patient care services and related administrative and support tasks. We’ll assess pharmacist and patient acceptability of pharmacy-provided services and estimate patient retention rate at three months of care. These are the timelines for our projects. With that, we turn to Jillian Pintye from University of Washington.
Nurse-facilitated PrEP delivery for adolescent girls and young women seeking contraception at retail pharmacies in Kisumu, Kenya
JILLIAN PINTYE: Good afternoon and on behalf of our collaborative team from Kenya Medical Research Institute, the University of Washington, and the Center for Integrated Health of Women, Adolescents, and Children, I am so excited to share the background and preliminary results of this ongoing study. I have no conflicts of interest to disclose.
First and foremost, I want to thank the amazing team in Kisumu who makes this work possible, with a special recognition for the co-PI of this project, Professor Elizabeth Bukusi from KEMRI. It is late in Kenya right now or she would be giving this talk. Here is a photo of our study staff training that took place in March and we are grateful for our team for giving this study their talents, their hard work, and commitment to make it a success.;
HIV incidence remains unacceptably high for adolescent girls and young women in East and Southern Africa. Pre-exposure prophylaxis HIV prevention tools are promising, with tenofovir-based daily oral PrEP and the dapivirine vaginal ring recommended by WHO and others for cis women. Kenya’s a leader for PrEP delivery and efforts are ongoing to increase access in health facilities with adolescent girls and young women as a priority group. Kenya integrated PrEP delivery in family planning clinics as one strategy to increase access for sexually active adolescent girls and young women seeking contraception.
Yet, up to 40 percent of Kenyan women access contraception without interfacing with facilities, including at retail pharmacies, and would be missed by current facility-based PrEP delivery platforms. Therefore, novel strategies to deliver PrEP to maximize prevention impact and also reach adolescent girls and young women who may not frequently attend health facilities.
Retail pharmacies can increase options for reaching individuals with PrEP and efforts are underway in Kenya to define pathways for pharmacy-based PrEP delivery, as we heard yesterday in Dr. Katrina Ortblad’s talk. We adapted a family planning clinic-based PrEP model and piloted PrEP delivery facilitated by nurse-navigators for Kenyan adolescent girls and young women seeking contraception at pharmacies. Pharmacies were purposively selected for this pilot based on proximity to a referral clinic, having a separate private area for consultation and HIV testing like the one pictured in here, which is common among Kenyan pharmacies. Nurses were stationed at retail pharmacies in Kisumu, Kenya for this pilot.
The model of pharmacy-based PrEP delivery used in this pilot also differed from some other ongoing projects in the region and also others that we’ve heard about today. It’s worth highlighting that to contextualize our results I’m about to show you. We stationed PrEP-prescribing nurses at pharmacies, all of whom had extensive experience already counseling adolescent girls and young women on PrEP and also delivering PrEP within public sector family planning clinics. After adolescent girls and young women purchased contraception at the pharmacy, nurses screened for eligibility, enrolled clients and then counseled on PrEP using a standardized script.
However, AGYW were free to ask any type of question, which they did, and nurses frequently counseled on family planning or relationships with their male partners, mental health, or other issues beyond just the nuts and bolts of how to take PrEP.
This was in addition to assessment and PrEP counseling per national guidelines, and a unique aspect of the model we used which was highly acceptable among AGYW as we will see later in the results. Nurses also dispensed PrEP under remote physician oversight and medical consultation was available as needed. Anybody who accepted PrEP was then scheduled for a one-month follow-up visit as part of this pilot.
Overall, we enrolled 235 adolescent girls and young women without HIV. Characteristics of the pilot participants are on the left compared here to adolescent girls and young women seeking contraception at family planning clinics who were enrolled in our team’s prior studies on the right. Just to see this comparison. We see several key differences. Adolescent girls and young women seeking contraception at retail pharmacies were more frequently under 18 years old and currently in school. They were less frequently married or had ever been pregnant. The distribution of contraception methods received at that visit differed greatly with emergency contraception as the most frequent method obtained at pharmacies compared to injectables and implants at FP clinics.
The behavioral profiles of AGYW seeking contraception at pharmacies compared to health facilities also greatly differed. AGYW at pharmacies had higher frequency of nearly all behaviors and experiences associated with HIV acquisition, including having a partner of unknown HIV status, exchanging sex for money or favors, drinking alcohol, experiencing intimate partner violence, or forced sex. Notably, PrEP acceptance was much, much higher among adolescent girls and young women seeking contraception at pharmacies compared to facilities.
We also conducted in-depth interviews with a subset of 41 participants to understand preferences for pharmacy PrEP delivery. Here are the amazing qualitative interviewers Helen and Caroline, conducting mock interviews and transcribing the audio recordings.
The quality of family planning and PrEP counseling provided by pharmacy-based nurse navigators was a key motivator for both PrEP use and preference for PrEP delivery at pharmacies. Other reasons included convenience, less wait times, less stigma, and being able to remain anonymous. This table presents exemplary quotations in support of these key themes. I’ll read just one. Most teenagers have sex without condoms. They also don’t know their partner’s status. You find they were ashamed to access PrEP at the hospital, because at times when you go, you don’t find a PrEP provider who’s in the same age group who they can be free with to access PrEP.
The pilot results were recently published in AIDS if you’d like to learn more and the qualitative work was presented at last year’s Adherence Conference and is currently under review for publication, so stay tuned. This pilot led us to develop a larger project which includes a cluster RCT supported by NICHD to determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among adolescent girls and young women seeking contraception at retail pharmacies.
It will also include a qualitative evaluation of acceptability, feasibility, and client satisfaction, and a cost-effectiveness evaluation of pharmacy-based PrEP delivery with and without the inclusion of nurse navigators. This cluster RCT is unblinded and currently underway in 20 pharmacies in Kisumu County and we anticipate enrolling 1,900 adolescent girls and young women.
Here are the cluster RCT’s inclusion criteria and we strived to make the study population as representative of adolescent girls and young women accessing contraception at pharmacies as possible. We’ll model two scenarios. The standard-based, pharmacy-based PrEP delivery only and also nurse-navigator intervention plus standard pharmacy-based PrEP. We’ll use the same model as presented in the pilot earlier.
We started enrollment just last month on May 17th, and as of last week, we enrolled 74 adolescent girls and young women, though that number today is a little closer to 100. It’s still early days. Nonetheless, our preliminary data are fascinating. Very similar to the pilot results, emergency contraception is the most frequent form of contraception obtained at the pharmacy at time of enrollment. PrEP awareness is generally high, but few participants had actually heard of the dapivirine vaginal ring before enrollment into the study.
Behaviors associated with HIV acquisition are also common as presented here. PrEP uptake is also very high, with about half of the participants self-selecting the dapivirine vaginal ring over daily oral PrEP. Among a subset offered STI testing at enrollment, which we’re doing at a subset of sites, all accepted testing and over 20 percent were positive for chlamydia so far. We haven’t detected any cases of gonorrhea yet. We anticipate that those numbers will grow over time. We look forward to continuing enrollments and presenting more mature results in the coming year to you all.
We gratefully acknowledge all of the study participants, the study staff, the Kenyan Ministry of Health and Kisumu County Government, who are our partners in this project. Plus, I’ll thank our funders at NICHD, especially our PO, Gretchen Buckler, and Sonia Lee, for their support of the study and HIV prevention among adolescent girls and young women. We also thank the Gates Foundation who supported the pilot work. Now please ask lots of questions. I’ll turn it over to our colleague, Jeremiah Johnson.
Questions for the Panel
JEREMIAH JOHNSON: Thank you so much, Jillian. Thanks to all of our panelists. You stuck so close to your time. We still have 15 minutes for questions for this panel. I see you all turning your cameras on and invite everyone else, all of our panelists, to turn your cameras on for this part of the discussion. We’re already getting some interesting questions, so we’ll just go ahead and dive in. One question that came up at the start, and I believe this question came up, Alex, when you were presenting. Please clarify if I get this wrong, but do you have partners in New York state and are you interested in collaboration in New York state?
ALEX DUBOV: We don’t have partners in New York state. We’re always open to collaboration, so definitely, please, if you have a chance here, my email probably is in the bio, so I’d be happy to discuss it further.
JEREMIAH JOHNSON: Great. Glad to play matchmaker on this important discussion. Another question that came up, are there differences in the resources, roles, skills, and business models needed to deliver PrEP via telehealth versus traditional clinical settings? I think anyone can answer that, but Heidi, you might be someone to jump in.
HEIDI WOOD: Happy to jump in. I think it boils down a lot into the logistics and just how you develop the model, but not necessarily different roles or skills. If you’re in a brick and mortar location, you have to think about clinic logistics and very valuable space that everybody’s fighting for, to use for seeing patients or clients. The benefit is, if you have labs on site, it’s a one-stop-shop. Everybody who comes in, they get their labs, they do their visit, it’s very tied up.
If you’re doing something telehealth, you’re able to reach people very far distances, you don’t have to worry about transportation barriers or that type of thing. However, we do find it difficult at times to track down lab results because our systems don’t talk to each other and that type of thing. Sometimes there’s delays. We actually have a PrEP clinic within our healthcare system that performs as an on-site clinic, just like, in comparison to our telehealth.
JEREMIAH JOHNSON: Great. Thank you, Heidi. Anyone else want to answer anything to that? Okay. To that point, I do want to jump in while more questions are still coming in with a question of my own.
Raiza and Tam, your research is really compelling in terms of how confident pharmacists are feeling in terms of prescribing PrEP. This has been a conversation since yesterday as well, that there’s a training and education element for pharmacists. I’m curious for the panel, how do we address this? I think yesterday we heard that maybe more pharmacists are receiving baseline training as they’re getting their education, but for people who are already out there and practicing, where are the resources to do the training? Is there, are there the modules, do the tools exist? Where should the resources come from? Does anyone have any ideas on that?
TAM PHAN: I guess I can kick this off. Within California, the Board of Pharmacy does have a free module that they provide for all pharmacists that are interested. Our respective local and statewide organizations, such as the California Society of Health System Pharmacists also provide these trainings. What is interesting, though, in California is that the California Board of Pharmacy does not have a statewide approved protocol yet, versus where the other states, they do have the screening forms available and it makes it to be more of a plug and play kind of implementation though, for the other states. I think, with that being said, we do need that additional support from regulatory bodies, along with some of the pharmacy and/or public health administrations.
JEREMIAH JOHNSON: Great. Thank you, Tam. Anyone else?
MARIANO KANMORI: Yes. I don’t have an answer prepared that I want to share that we make a proposal to using implementation science to answer these questions. We should use implementation science to answer these type of questions.
JEREMIAH JOHNSON: Thank you. I see some nodding heads there. It’s not just knowing that the module exists, but how do we get it to the people and get them to actually get the information into their brains. There are those additional steps there that we have to pay attention to.
We have another question in here, thanking you for the presentations, that you’re all really wonderful, which I think we can all agree. They are wondering if anyone is considering using pharmacy drive-thrus in any way. Sometimes that can be a more private way to interact with pharmacists than obtaining medications at the counter in-store where there are other customers. Any thoughts on that?
ALEX DUBOV: It actually could be a good idea for us if patients will prescreen using the mHealth tool and in that way we will be able to interact with the community health worker and it can come to them, to the drive-thru if they have also confirmed recently HIV test. That potentially would be a very good idea.
JEREMIAH JOHNSON: Great. Thanks, Alex. Another question. This one is for you, Jillian. Were pharmacists involved in the PrEP intervention in Kenya in any way? You talked a bit about this, as well as nurses being involved, but maybe some clarification.
JILLIAN PINTYE: Sure. Pharmacists are the key partner here. They’re involved every step of the way and really pharmacy-based PrEP delivery, that base model, and what we consider the standard of care in the Cluster RCT is pharmacists that delivered PrEP. What we’re testing in this RCT is the nurse-navigators as really the intervention, or this additional facet that’s snapped on to pharmacy-based PrEP delivered, delivered by pharmacists. The idea is among the adolescent girl and young women population, having that peer-like navigator. Our nurses are young women themselves, primarily, they are talking about other issues related to what’s going on in the adolescent girls and young women’s lives.
That is supportive to PrEP use and decision making and making appropriate choices within the context of their lives and how to fit PrEP into these unique situations that adolescent girls and young women find themselves in. So yes, to answer your question, we’re sure the pharmacists are definitely the key partner and really driving pharmacy-based PrEP delivery in all the models and the nurse-navigators are really intended to enhance and compliment that approach. That might have specific utility specific to adolescent girls and young women.
JEREMIAH JOHNSON: Great. Thank you so much. A few more questions about training and then actually a comment from Maria Lopez just reminding us that yesterday it was mentioned that APHA is creating a national training certificate for pharmacists, so that’s an additional note in terms of training. We have a question about, are pharmacists required to take trauma-informed trainings as well to provide appropriate services to different clients. Any thoughts or answers on that piece?
HEIDI WOOD: I will say that for the services we’re providing, it’s overseen by a collaborative practice agreement within our health system’s P&T committee. It really is individual choices of what training is required versus not required, although that is very important to take. I also wanted to give a shout out to AIDS Training and Education Center, which I believe is national, has amazing resources for training. Our Midwest Chapter, they’re extremely supportive in making sure we have all of the resources and training that we need. Again, phenomenal.
JEREMIAH JOHNSON: Wonderful.
ALEX DUBOV: I also wanted to comment on this. We do a bit of training for the pharmacies that are working with us, specific to counseling and some of the pharmacists or techs are also taking HIV test certificate, and there is a counseling component embedded in that training as well. I agree with the AIDS Education resources. Our chapter here, as well, is very helpful in that regard. That would be a great resource nationwide.
JEREMIAH JOHNSON: Great. A few other questions about the nature of the interventions that everyone’s discussing. Are any of the pharmacy-based PrEP interventions that we’re presenting using injectable PrEP? If so, has that posed any new challenges or potential benefits from an admin perspective?
RAIZA BELTRAN: We can answer. Also Alex can discuss this. We are working in the same area. Right now it’s currently still relatively new from what we understand, at least pharmacists are still considering. There are a few that are exemplar pharmacies that are really implementing LA, or long acting injectable PrEP. It’s still a new modality that pharmacies are looking at, at least here in California, it seems like.
ALEX DUBOV: Yes, I agree. There’s only a few specialty pharmacies that have experience administering long-activing injectables like psychiatric long-acting injectables, but they’re still several main challenges. Getting the medication, then getting reimbursed for medication, and especially the issue of services and administration fees becomes even more pronounced, unlike with oral PrEP. Overall there aren’t many - I’m not aware that we have in California. There are a few pharmacies considering, potentially will start soon, but we’re still working on multiple pieces that potentially can be involved.
JEREMIAH JOHNSON: Great. Thank you for that. I have a bit of a related question myself, which is actually in terms of the advent of generic medications coming online. We have full generic competition for daily oral PrEP, as of April 2021. I’m curious if there are any thoughts on how the reduced price might open the door to different ways of delivering PrEP through pharmacies, or if there are things that we need to do in order to maximize that. Also importantly, is there a role for researchers, in terms of figuring out how to unlock the potential?
HEIDI WOOD: I would say with the introduction of the generic oral option, it’s helped us care for people that are either underinsured, who don’t qualify for programs that pay for, like med assistance programs that would otherwise pay for the medication, or we have young individuals who are covered by their parents’ insurance, but are insurance-averse due to privacy concerns and then don’t qualify for programs to reimburse or pay for the medication because they technically have insurance. Using different cards to get generic oral options is what we’ve been doing.
JEREMIAH BROWN: Great.
MARIANO KANAMORI: I’d like to add something. I think it is important to provide information to the community. At least here in Miami, Latinx do not know that PrEP exists. If they don’t know that that exists, we cannot talk about different types of medications they can access. That’s why I believe that our model with CVS Health will help many Latinos to understand and to learn that PrEP exists.
DREXEL SHAW: Just to chime in slightly with Dr. Kanamori. I think also sometimes like with other conversations, there are just so many misconceptions about PrEP and then the difference between the brand now versus a generic version of it. You hear people, particularly communities of color in the south where a lot of folk are saying, well this medication’s less effective than that. It’s really the role of the pharmacist to help support that reeducation to community as well and pharmacies to take that stance between the difference of the two and show that they’re both effective. For us, that’s the stance, that we’d like to continue to educate, is going to be a revolving theme around the rest of this forum because it’s necessary to dispel those myths that are still around.
RAIZA BELTRAN: I was just going to add to Dr. Kanamori’s point. Our project is really trying to build relationships across different sectors, particularly with public health departments to help build that awareness and pull them in our work and help build demand across different counties. We’re really trying to bridge those relationships so public health can help and other sectors can help in increasing that demand, including community-based organizations. That’s one of the things that we are pushing for in our work.
JEREMIAH JOHNSON: Thank you so much. We’re at time. I am just going to say very quickly, again, I have to plug some of the national PrEP program discussion that we’re talking about for uninsured and underinsured people. One of the significant buckets that we keep talking about is that we need to have campaigns, buy-in, for effective communities, in order to get messaging out there that’s truly accessible for people. I think there’s a lot of exploration here to see what can be done there. Maybe some research questions.
Also, connecting to some of those other points of care in community. Other people are receiving services. Heidi, it’s really struck me, through the Iowa Telehealth Program, how many people enter through other public health entities. It’s those touchpoints, so curious how those partnerships that can form can actually be the way that people find their trusted pathway to a pharmacist to get a PrEP prescription. I think that’s about where we’ll have to leave it. Many thanks to everyone for all of your questions, for all of the discussion. Thank you to the panelists for all of your insights. With that, I’m going to turn it back over to Mike, who has a poll question for us. Thanks, everybody.
Live Poll 3: Role of Pharmacies in PrEP Starts and Delivery
MICHAEL STIRRATT: Thank you so much Jeremiah. An excellent panel. Thank you to all the presenters. Before we head to a break, we do have a poll question for all of our attendees. You’ll see those on the screen here and you can access the poll question in one of two ways. You can use the QR reader on your cell phone to scan this QR code, or you can use your computer to go to menti.com and you can enter the code that you see on your screen. It’s in the lower left. That will help you to access this poll. You’ve got two ways to access the poll.
Our question today, following from these discussions about the opportunities and challenges with PrEP delivery through pharmacists and pharmacies. How important are pharmacy-delivered PrEP services to a comprehensive HIV prevention strategy? Yesterday we heard Harold Phillips talk about how pharmacists and pharmacies are one critical component of a comprehensive approach to HIV. Today we’re asking, how important will pharmacy-delivered PrEP services be to a comprehensive strategy in HIV prevention? Please feel free to access the poll either through your computer or through your phone. We understand that when you select your response, you then have to hit the word ‘submit.’ You both choose the response and then you also hit submit to make sure that your information is logged with the system.
We have more responses rolling in here. I think we’re about to go north of 50 people responding. We’ll keep the pool open, but sure enough, and perhaps not entirely unsurprisingly, we see that in our meeting attendees today, there’s a large majority of people who are thinking that pharmacy-delivered PrEP services are very important. Very important to our comprehensive HIV prevention strategy. With some smaller numbers trailing from fairly to just important and then slightly important. That’s very interesting. Very important feedback to see and reflects a further delivery strategy that we want to build on as we go forward for PrEP with pharmacies and pharmacists.
We’ll leave that open. If you’re still responding to the poll, please do. We do want to count all those responses. The meeting is running right on time. Thank you all for helping with that. We will now take a five-minute pause. Take a little break for a little rest and refreshment. We’ll be back at 20 minutes after the hour, that is 2:20 Eastern. That will be for our panel on HIV treatment, which will be moderated by one of the pioneering voices in pharmacist and pharmacy-based HIV care delivery, Glen Pietrandoni. We look forward to seeing you in five minutes. Thanks so much.
Topic Panel Four:
Advancing HIV Treatment through Pharmacies and pharmacists
Panel Speaker Introductions
GLEN PIETRANDONI: Good afternoon, good morning, depending on where you’re at. I’m Glen Pietrandoni, Chief Advocacy Officer at Avita Pharmacy, and thank you for the great introduction. Today we are going to switch topics a little bit, talking about advancing HIV treatment through pharmacists and pharmacies.
And I’ll be joined today by an esteemed group of panelists, many of them I’ve known for quite a number of years. We have Kathy Byrd from the CDC, Katrease Hale, a public health consultant, and Rachel Browning from NASTAD. Taylor Ward from the Boston Medical Center, and Jennifer Cocohoba from UCSF. So, collaborations between community pharmacists and medical providers can lead to improved outcomes for people living with HIV and can play a major role in ending the HIV epidemic.
With over 30 years of complex therapies, drugs for opportunistic infections, and comorbidities, pharmacists have played an important role over the years in making sure patients are adhering to their medications, helping them with dosing schedules and managing through any side effects and things like that. That even with simplified once daily therapy and combination drugs, people still struggle with adherence, and obviously we also know that patients sometimes fall out of care, so retention is a very important piece as well.
Pharmacists often can play an important role here, because as we see in the pharmacy we build relationships with patients over time, we’ve built relationships with their providers, and we know the family sometimes of the patient. So we have a very strong relationship basis for supporting those patients in between medical visits.
But as we know, ideally people would be able to use a single pharmacy for all their medication and have a complete picture of what’s going on with that patient. They’re often using multiple doctors, they’re getting drugs from different programs and different access points. For their medication it becomes sometimes very difficult to know everything that’s going on with a patient’s medical medication history.
When you think about new modalities of injectable long-acting drugs, right now with IM and maybe in the future with sub-cu or other dosing administration models, I think there are opportunities and of course challenges on how pharmacists can play a role in administering medications and working with providers to keep people both adherent and also retained in care.
So as we’ve seen with COVID, our pharmacists can step up to the plate, and are really important healthcare providers being leveraged in the community, and as we know in most cases there is a pharmacy nearby, not in all cases, obviously in communities that are struggling with access points pharmacists can be considered I think in a very important way looking down the road in how we can help with treatment adherence and retention, and also reducing community viral load, and also reducing new infections.
So with that, I would like to turn it over to Kathy Byrd from the CDC for her first presentation.
Supporting Adherence and Viral Suppression Through the Patient-centered HIV Care Model Project: A Collaboration Between Community-based Pharmacists and HIV Clinical Providers
KATHY BYRD: Good afternoon, and good morning everyone. As Glen mentioned, my name is Kathy Byrd, and I would like to give an overview of the patient centered HIV care model project, which was a collaboration between community-based pharmacists and HIV clinical providers.
I have nothing to disclose. By the end of this presentation, what I would like you to take away from this talk is this: Collaborations between community pharmacists and physicians can improve HIV viral suppression.
Between August of 2013 and September of 2016, CDC, Walgreen Corporation and the University of North Texas Health Science Center System College of Pharmacy collaborated to develop and implement a demonstration project called the Patient-Centered HIV Care Model.
The goal of the model was to increase communication and collaboration between community-based pharmacists and primary medical providers for patient centered care, with the objectives of improving adherence to therapy and HIV viral suppression.
The project was implemented at ten sites, which were comprised of a medical clinic partnered with one or more community-based HIV specialized retail pharmacy. And all project pharmacists had been previously trained in HIV treatment and prevention, HIV counseling, and HIV specific Medication Therapy Management or MTM, which I will explain in the next slide. A total of 765 persons were enrolled in the project, with each participant receiving at least 12 months of services.
Medication therapy management or MTM is a range of services provided to patients to optimize therapeutic outcomes. MTM starts with a comprehensive or targeted medication review where the pharmacist interviews the patient to gather information about medical and medication history, and the patient’s concerns about their health conditions and medication use.
The pharmacist then reviews the patient’s medications for indication, effectiveness, safety and adherence, and determines if there are any medication related problems. Next, the pharmacist creates a plan based on the identified problem. There are other components to MTM. These include the personal medication record, Medication-related Action Plan, intervention or referral, and documentation and follow-up.
The patient-centered HIV care model was built upon the MTM model, but the model starts at the clinic. The clinic gathered all pertinent medical information about each patient.
And this could include complete medication lists for all current medications, both for the patient’s HIV therapy and for all other chronic conditions, complete medical problem lists, lab test results for HIV viral loads and CD4 counts, as well as other lab test results such as liver function tests.
And this information was then shared with the clinic’s partnered pharmacists. The pharmacists got baseline information, and then updated information quarterly. With this information the pharmacist had what was needed to most effectively conduct the MTM.
In addition to conducting the MTM, the pharmacist provided additional services, including monitoring prescription refills and lab results, and providing adherence support. And some of the pharmacies provided some ancillary services, such as immunizations.
If the pharmacist identified any medication-related problems, either through the MTM or by monitoring prescription refills and lab results, they communicated those findings to their partner clinic, and collaborated with the clinic providers to create and implement a plan to resolve the issues. This was a continual process between the pharmacist and the clinic medical providers.
The typical encounter schedule is shown on this slide. Once a person was enrolled in the project and received an initial Comprehensive Medication Review, they then receive monthly support from the pharmacist as needed, and quarterly medication therapy reviews. And the patient continued to be seen at the clinic every six months, or more often as needed.
The proportion of persons virally suppressed, defined as a viral load below 200 copies per milliliter in the last test in a 12-month measurement period, was calculated pre- and post-model implementation. The relative percentage change of the proportion of persons virally suppressed was calculated pre- to post-implementation. Cost and cost-effectiveness was determined using standard methods.
There were a total of 765 persons enrolled in the project. The median age of the participants was 48 years, and the majority were non-Hispanic black, male, and Medicaid insured.
This table shows the proportion of persons virally suppressed pre- and post-model implementation. Overall, viral suppression improved 15 percent, from 75 percent pre-implementation to 85 percent post-implementation.
While viral suppression improved among most demographic groups, what is shown on this slide are the more notable improvements, seen among younger persons, who improved between 26 and 83 percent, among non-Hispanic black portions the proportion who were suppressed improved 23 percent.
And persons who received care at clinics funded by the Ryan White program and privately insured persons also saw notable increases, at 23 and 31 percent respectively.
We wanted to look at whether improvements in viral suppression held for people with additional barriers to care, such as mental illness. So we did a sub-analysis of persons with mental health commissions, which you see on this table.
As you can see, viral suppression improved for persons with mental health conditions, with notable improvements among persons with HIV with a mental health condition and substance use. Among these individuals, viral suppression improved over 30 percent.
The model was implemented at a relatively low cost, with the average cost per patient visit of $48. The model had an incremental cost per patient virally suppressed of a little over $5000.
The intervention was cost-savings, as the program cost was lower than the lifetime HIV treatment cost averted, and in our threshold analysis the intervention could remain cost-saving if at least eight additional patients out of 155 were virally suppressed, and the intervention that would be cost effective is as few as four additional patients were suppressed.
So, as mentioned earlier, collaborations between community pharmacists and physicians can improve HIV viral suppression. However, such collaborations don’t happen organically, they must be developed, which requires an interest by both clinicians and pharmacists, and an understanding of what each can offer to the collaboration and to the patients.
Also, clinicians would likely benefit from training on how to engage and work with community pharmacies. Pharmacists with specialty training in HIV care or experience working with persons with HIV are most suitable for these types of collaborations.
And pharmacy accessibility to electronic health records can facilitate these types of collaborations. And lastly, and possibly most importantly, to increase collaborations between clinicians and pharmacists, reimbursement for pharmacist services, beyond reimbursement for prescriptions, needs to be addressed. Thank you. Now I will hand it over to co-presenters Katrease Hale and Rachel Browning.
Data to Care Rx: Engaging pharmacies and pharmacists in proactive efforts to retain people with HIV care
KATREASE HALE: Good afternoon. Rachel and I are both really excited to be here, and to talk with you today about Data to Care Rx. So, what is Data to Care Rx? It’s based off of a program called Data to Care, which uses information like HIV lab reports, so CD4s and viral loads, it uses those to link people back into medical care.
However, when we were doing this work, we just kept being plagued with this feeling that we’re not reaching people fast enough when you wait 15 months to engage with someone and wait for them to be out of care, you’ve really missed this critical window of intervention. And so Rx has allowed us to take that one step further and intervene much earlier by using prescription refill information.
So, what are the goals? Number one is to increase the level of involvement for pharmacists in the current care model. Why are we leaving pharmacists out? They are a critical member of the care team and should be at the table.
And then number two is to increase viral suppression among people living with HIV. If we want to end the epidemic, this is one clear way of doing that. Rx not only allows you to get people viral suppressed and maintain that viral suppression, but by intervening earlier we are able to address barriers as they are occurring instead of waiting for, like I said, a certain amount of time to pass by.
And so by doing that health departments are able to link people with the necessary care services that are already in place, maybe like early intervention or food banks, or maybe transportation has become a barrier, or maybe someone just needs help filling out some new paperwork, they’ve lost their insurance, things like that. And so instead of waiting for a year to go by you’re waiting to kind of intervene at the time when that barrier is becoming an issue for the client.
So this came up a lot of different ways, depending on where you are and what works in your care model. When we implemented this in Detroit, we decided to go with a three-week implementation. We originally considered a 30, 60, 90 days, and on engagement with pharmacists they were like absolutely not, we have to do this much quicker than that.
And so this three weeks, what it looks like is week one, when someone fails to pick up their prescription, the pharmacist reaches out and uses their normal engagement methods with the client. When that hasn’t worked, and a week has gone by, they then reach out with the prescriber. So the clinician that prescribed the medication.
When that hasn’t worked, week three, they pass the information over to the health department. And then normal Data to Care strategies are used to locate and relink the individual either back to the pharmacy, or maybe enough time has passed by that they need to be linked back to medical care.
So, if anyone is interested in doing a project similar to this, my first advice would be engagement, engagement, engagement. So whenever we started this, we first established what we call a core group, and this is the group of individuals that helped us think about what a Data to Care Rx project could look like.
Before going and talking with people living with HIV we wanted to be very conscious that not everybody has heard the word survey yet, or knows that when you’re diagnosed, your labs are then monitored or sent to something called state public health. And so this group really helped us think about and frame that, and then we kind of went on what we call our roadshow, and we’d meet with any group that would talk to us.
And so these are just four of the critical groups. So of course, pharmacists and pharmacy staff were critical to developing this project. People living with HIV. I would advise kind of hitting, we would call it the low hanging fruit. And so there are already these groups established that you can go and meet in your area, planning councils, and Ryan White will often have regular scheduled meetings that we would hop on. And so these are all really wonderful groups to get feedback from.
I’m going to turn it over to Rachel now to talk a little bit about the work that we have been doing through NASTAD.
RACHEL BROWNING: Thank you, Katrease. So next I will be talking a little bit just around the dissemination of the Rx model. We know that this model is effective, and part of the chart of NASTAD has been how to get this information out to other interested jurisdictions. A lot of times people are interested in working with pharmacists as it relates to HIV treatment, but don’t know where to begin.
So some of our current projects, right now we’re working on an EHE SCP project that’s looking to develop a community of practice where we’re going to engage EHE phase one jurisdictions to kind of put them through a four-month readiness community of practice to really help them assess the current infrastructure. So do you already have some of the core pieces needed in order to implement the link up Rx model, and if not, how can we help you and provide resources for you to get to that point.
After that, folks will kind of transition into a one-to-one TA situation, and then we can provide more specific support. And that will be launching in July, if there are folks on this call who are interested in that.
We are also providing one to one TA with Broward County Florida. That program is set to launch in November of 2023. And so this is a timeline of how we have been moving Broward through the process. Right now, we are in the phase of starting to engage with pharmacies. They have done a really good job on the ground of engaging with corporate pharmacies as well as ADAP pharmacies as well.
In terms of previous projects and our dissemination, also through EHE SCP we held a Data Consultation Promising Practices Webinar, where we had roughly 20 jurisdictions come, and we talked about the Link-up Rx Model, and some of the foundational pieces needed in order to implement that.
And then in addition, there was a HRSA SPNS project that we worked on that was a multi-year funded project that was through the Center for Innovation and Engagement, where we actually evaluated the Link-up Rx Model, and then subsequently developed an implementation guide that provides steps on how to replicate the innovation. We did a cost analysis and then also developed a shorter intervention summary as well. And I would encourage folks to check that out at CieHealth.Org.
Next, I will just talk a little bit about evaluation findings and lessons learned. So something that we learned from the evaluation model is that the Link-up Rx Model is effective with addressing viral suppression. It also reduces the instances that folks are seeing on the Out of Care list, and then it also increases re-linkage to care as well.
We also know that pharmacists are great partners. As Glen mentioned at the top of this session, we know that these folks have interpersonal relationships with clients that have built trust over time, and we also know that these folks have their own retention efforts that can be of use to health departments, as well as specialized training for adherence counseling and retention and care.
One of the things that we also learned is that it is imperative that there is an insurance navigation team or someone who is well trained and well versed in insurance in order to help clients navigate that system.
In addition to our quantitative results, something that we also found was that clients were really receptive to the Detroit link-up Rx model. And part of this is because they included client voice early on from talking about how data would be used, why the health department was having an interest with working with pharmacists, and what the intended benefits would be for communities.
So it’s really important if you’re interested in working with pharmacists, think about how you can include community voice early on and really get people to buy in. Additionally, having cross-collaborative task force, such as the insurance task force, were huge as well, just to bring in multiple partners in order to really address some of the challenges faced by clients.
So next I’m going to turn this over to my co-presenter, Taylor Ward. Thank you.
Implementing Injectable IV Treatment in an Ambulatory Infectious Diseases Clinic through Pharmacists and Pharmacy Technicians
TAYLOR WARD: Good afternoon. I am looking forward to talking to you all today about injectable HIV treatment in an ambulatory infectious disease clinic through pharmacists and pharmacy technicians.
Cabotegravir-Rilpivirine, or CAB/RPV, was approved as a first in class long-acting injectable antiretroviral regimen to treat HIV-1. We have seen interest increase over the last year and a half, and there has been a greater demand to offer this medication for in clinic administration. We know that CAB/RPV injections require additional clinic time and resources than traditional oral therapies, which makes it very important to have a well-developed plan prior to implementation.
Boston Medical Center is the largest urban essential hospital in New England. It is the principal teaching affiliate of Boston University School of Medicine, and about 30 percent of patients speak a primary language other than English.
Within Boston Medical Center we have the Center for Infectious Disease, which is the largest HIV/AIDS program in New England, which allows HIV-infected persons to receive ongoing primary care within the CID comprehensive care model.
We have a collaboration between medical providers, nurses, clinical pharmacists, pharmacy technicians, medical case managers, benefits navigators, and we have additional rotating support services such as psychiatry, neurology, gastroenterology, and oncology within the clinic.
CAB/RPV as mentioned before is the complete injectable antiretroviral regimen, which comes as a two drug co-packaged product with CAB/RPV, and then the optional 28 oral lead-in that can be used when initiating therapy.
So within the CID clinic we have developed a pharmacist-led and pharmacist/pharmacy technician collaboration to implement the injectable CAB/RPV antiretroviral clinic. How this works is physicians refer interested patients to be scheduled with a pharmacist for their initial interest visit.
If patients are eligible and they remain interested, we perform a benefits investigation, which we utilize pharmacy technicians to perform that benefits investigation, complete the prior authorization if necessary, and then document that for the clinical care team.
Once we confirm that coverage is available for this patient, they’re scheduled with a pharmacist and a nursing visit. And the pharmacists are responsible for these injections during the first six months of their injectable therapy.
After six months, if the patients are stable and doing well, we’ll discharge them back to the provider/nurse team for future administrations and monitoring. But, if at any point during treatment there is an issue or question, patients can be referred back to the clinical pharmacist for assistance such as changing back to oral therapy such as they have upcoming travel, adverse effects, an interruption in their insurance, or if patients prefer to switch back to oral therapy, they’ll meet with the pharmacist.
I want to just walk through how this works. The first is the pharmacist visit, we call it the interest visit. This is initial clinical review by the pharmacist, reviewing for resistance mutations and antiretroviral history. Determining their Hepatitis B status to confirm if they are an eligible candidate to switch to long-acting injectable CAB/RPV. We talk about pregnancy, review their BMI to determine the needle length that’s needed for their injection, identify any interactions, provide patient counseling, and send the prescription for the oral lead-in if appropriate.
Once we send over that prescription to the health system’s specialty pharmacy, the pharmacy technician, which is embedded within the clinic, will take over from there to review insurance coverage, determine if it is a medical or a pharmacy benefit, submit the PA, document that in the medical record, and then coordinate with our pharmacy for dispensing and delivery.
Once the patient is ready for their first injection, they’ll come for a combination co-visit with the pharmacist and the nursing staff. The pharmacist will review what a target date is, how to manage side effects, talk about any upcoming travel plans to help ensure that they’re getting scheduled correctly, confirm that there’s no upcoming insurance changes, and then the nurse will administer the injection. Pharmacists will order lab monitoring and help assist with scheduling the next appointment.
Within the CID clinic we have initiated 113 patients on CAB/RPV. There are two pharmacists within the CID clinic, and two pharmacy technicians, and then four nurses that manage this program. We have 104 that currently are receiving CAB/RPV, with 102, the majority on every two months, and two patients on every month. With 10 that are discontinued, nine true discontinuations and one was pregnant and then returned postpartum.
Two have had side effects of pain that occurred after their first set of injections, one left insurance after they received their first set of injections, so we switched them back to oral therapy through manufacturer assistance. One was lost to follow-up after getting 11 months of long-acting injectables. Two moved out of state. One had an increased viral load. And one was deceased for a reason not related to the injection.
It's a lot to get this process up and running, but it is really important that you continue to maintain the clinic as well. So we have weekly interprofessional huddles between clinical pharmacists, nurses, and pharmacy technicians.
Review all the patients on injectables, confirm their next appointments are scheduled within the target treatment window, confirm medication is filled and stored in clinic for administration, and talk about any insurance issues, patient challenges, or process improvements that we have as a group.
Here is kind of an example of our excel sheet that we use to track these patients. So for anyone on this call that may be looking for something to help kind of guide them on how to keep track of these patients, these are just kind of an example of the columns that we use to help track them, and who is responsible for each column based on the color.
So the pharmacist role for interest visits is excluding ineligible patients with previous resistant mutations and providing that comprehensive education and expectations. They come into the pharmacist visit with limited to minimal understanding of what the injectables are. The physicians, they just say hey, are you interested, and turn them over.
During the injection visits, provide clinical care for them for the first six months, monitor their viral load trend and allow for early interventions if we identify any patients that could potentially be failing therapy, before resistance develops. And then provide the clinical expertise on the management of missed doses, travel plans, or timing of injections.
For future recommendations, we have HIV care beyond the CID clinic. We have HIC care currently in internal medicine, pediatrics, addiction medicine, and our OB clinics. So being able to continue this model in other clinics would be a future goal. And we know that these patients need a lot of support, so we’re utilizing case management as part of our team, or some type of patient navigation would be really helpful for appointment reminders or transportation to visits or coordination of care. Thank you for taking the time. I’m going to turn it over to Jennifer Cocohoba.
Exploring Pharmacy-Based Delivery of Long-Acting Injectable HIV Treatment
JENNIFER COCOHOBA: Good afternoon, everybody. My name is Jennifer Cocohoba, from University of California San Francisco, and on behalf of our team I am pleased to present some data from our research project on exploring pharmacist and pharmacy-based delivery of long-acting injectable antiretrovirals.
I think this is the audience that I don’t have to explain to why we are considering how to incorporate community pharmacists into the workforce of long-acting antiretroviral therapy.
Data has been published talking about real world experience in clinics and have demonstrated some feasibility, but we are still seeking ways to offload some of that work and shifting some of that long-acting antiretroviral therapy workload to community pharmacies to differentiate these care models. And there are lots of potential benefits for patients, clinics, and for pharmacies.
I think the bigger question is, is pharmacy ready? We heard from Elyse Tung yesterday about some pharmacies that do have an optimized setup and are going to move forward with these models of care. But I think it is also really important for us to understand the broader pharmacy landscape, if the goal for incorporating community pharmacies is to broaden the reach of pharmacists in assisting with these therapies.
Our research, which is actually sponsored by Viiv Healthcare and independent investigator-initiated grant is to evaluate not only pharmacy staff but clinic staff and patient attitudes towards the administration of long-acting antiretrovirals within community pharmacies, as well as identify those barriers and facilitators that can either help or stand in the way of these.
We are nearing the end of our mixed method study. And we can see here we included persons who were older from 18 from four geographic areas, in California, South Texas, Central Alabama, and South Florida. For our clinic and pharmacy staff we asked that they had at least a proportion of their clients that they served were living with HIV, so at least five percent of their total population.
And for persons that were living with HIV, we asked that they were either on antiretrovirals or at least eligible for antiretroviral to be a part of the study. We used kind of the normal data collection and data analysis methods as listed here.
So, who responded to our study? To date we have 14 pharmacy staff members, 19 clinic staff members, and 20 persons with HIV. And as you can see here for the pharmacy staff and the clinic staff, they’re around 40 years of age, predominantly female, and also describe themselves from a racial background as other.
Some of the different areas, you can see the breakdown of the different geographic areas of the United States. And many of them had been serving persons with HIV in that space for ten years or more.
Interestingly, the persons that we surveyed, at least the pharmacy staff, did not feel that they were very knowledgeable about long acting antiretrovirals, while the clinic staff felt a little bit more knowledgeable about long-actings.
Our persons with HIV, they were a little on the older age, if you want to call 50s older, but with a wide standard deviation you can see here. Again, predominantly female, and predominantly self-reporting their race as black. Many of them had been diagnosed for a very long time, so a median age since diagnosis was 16 years. A third of them had been diagnosed for greater than 10 years. All of the persons with HIV who participated in our study were on antiretroviral therapy, and we also captured a third of our participants who were already on long-acting antiretroviral therapy.
This might not be a surprise to the persons that are attending this meeting, a large chunk of patient participants reported that they typically used a retail or chain pharmacy to obtain their antiretrovirals. While a quarter of them utilized mail-order pharmacies to obtain their medicine. A lot of them picked up their medicines at the pharmacy, but also a good chunk of them, over half, utilized grocery delivery services or mail.
I think we talked yesterday about the number of visits that a person on average makes to the pharmacy, and that was no different, and echoed in our study, with persons stating that they at least visited a pharmacy one or more times per month, or sometimes every two months, but basically 75 percent of our patient participants said they at least walked into a pharmacy once every two months.
In our research we utilized three scales, the acceptability of intervention measure, appropriateness of intervention measure, and feasibility of intervention measure, to assess whether having community pharmacies administer long-acting retroviral therapy was acceptable, appropriate, and feasible. For each of these scales the maximum score is 20 points, and for a composite of the three the maximum would then be 60.
As you can see from this slide, acceptability, appropriateness, and feasibility was rated pretty high amongst all different persons, whether they were pharmacy staff, clinic staff, or persons with HIV, with clinic staff being more enthusiastic, slightly, about those three measures, compared to pharmacy staff and patients.
In our qualitative interviews, which were based on the theory of the (inaudible) we can see here that there was a lot that came out from these interviews. And for brevity and sake of time I’m not able to share some of the fantastic quotes that all of our participants shared.
One thing that struck us is that a lot of the things that were stated by our participants were these ideas that were very good in theory, and there were a lot of pros to moving some of the administration of long-acting retrovirals to pharmacies.
And they said things that we’ve heard in this meeting already, like pharmacies increase access, they’re available on every corner, patients choose where to get their shots, pharmacies are open later, on weekends. And there’s no co-pay that’s going to be needed at the pharmacy, it’s going to be cheaper for patients.
And then you also heard from our pharmacy colleagues that maybe not all pharmacies are suited to deliver these services, perhaps specialty pharmacies are better. We want an appointment system, I don’t think we can work with walk-in. And then the same lines we’ve heard all throughout this meeting about reimbursement for clinical services and sustainability of providing this.
With regards to facilitators and barriers, some of the things that were very strongly evident in our research is that across all sectors it was the general positive strong regard for pharmacists, particularly with people’s experience with pharmacies, with immunizations, and during the COVID-19 pandemic, really just kind of strengthened people’s views of pharmacists. There were strong relationships between patients and their pharmacies, as well as clinics and their pharmacies.
And a sense of clinic overwhelm, being able to provide these medications for their patients with the overloaded nursing staff, space, et cetera. The things that came up as barriers are probably no surprise, the ability to have private space, obviously staffing concerns, again reimbursement, and then the need for training for gluteal injections for some of these therapies.
There was a bit of discussion as well about the complexity of an intervention. Some questions that were raised by our participants were: Who is going to take on whish task? How do we communicate across clinics and pharmacies when we’re treating patients at the pharmacy but also have their providers in the clinic? How do we track patients? What happens when patients go to the pharmacy and the clinic is unable to capture them for injections and other things that they need them there for?
So how do we move the needle? I think so far our research has demonstrated generally positive support for pharmacy administered long-acting antiretrovirals, but a lot of trepidation about the implementation.
A theme that’s emerging is that there’s probably not a one sized fits all for long acting antiretrovirals and long-acting PrEP. We have to take into account things like local context, and potentially stratify pharmacies around the continuum of responsibility. Some will dispense, some will administer, some will have the whole gamut.
And there are other models that we are considering, such as the clinic within pharmacy, or having a nurse within the pharmacy. And the balance to that is noting that some pharmacists are just really excited to be able to expand their scope of patient care, so how do we balance all that.
I think our next steps and future directions are to develop this more concrete blueprint guidance that is stratified or stepwise type of pharmacy care models for long-acting antiretroviral therapy, and also really lobby for expanded systems for patient tracking that goes across clinics, pharmacies, promoting reimbursement, and of course sharing our pharmacy and clinic best practices to move the needle forward. And with that I’ll turn it back over to Glen.
Questions for the panel
GLEN PIETRANDONI: Thank you all. If I could ask all the co-presentersto turn on their cameras and their microphones, that would be great. Thank you all. These topics have been swarming around in my head for the last many, many, many years, and I think you’re at the same point in some of these questions, what is the answer? And I have a couple of my own. I guess I do have one on the chat, but I’ll wait on that for just a second.
The one question I had, maybe this is for Katrease, is HIPAA a concern? Because if I remember, back when I was in the pharmacy and we had heard about this idea of sharing with health departments our fulfillment data. Either perceived or real, is there a HIPAA concern on how we share data, and is it okay to share data between us and the health department?
KATREASE HALE: Yes. This has come up a lot, as Rachel and I have been talking to different jurisdictions, and it really will be dependent on state by state. So when we started this program it was in Michigan, and there the public health code is written very liberally, and it’s interpreted very liberally, which is really a benefit. It’s written so that the state can share information with providers for the purposes of preventing the transmission of HIV and for caring for people living with HIV.
And so a key definition there is provider. And so some states consider a pharmacist a medical provider, and some states do not. In Michigan, pharmacists are considered medical providers. So therefore, we were able to share information about clients that they were serving with pharmacists without any real barriers, which was a real blessing. But you know each state’s public health code will be written a little bit differently and interpreted a little bit differently. Does that answer your question?
GLEN PIETRANDONI: It is always fun to hear the answer it depends, that is always common in our field, I know. I had another question, maybe this is for Taylor. Obviously, your models are within clinics of a large health system, but had you considered any type of pharmacist type program in the community setting within your community, within Boston or New England?
TAYLOR WARD: Yes. That is actually something that we are looking into over the next year or so. It is definitely going to be a big project. But I think Jennifer may have some insight into some of that.
We are looking to use our community health centers or our community pharmacists that are embedded in those locations. I think one of the things we really need to think about is that communication between pharmacies and the provider’s office, and making sure everyone is kind of on the same page around what’s going on.
But definitely an area we’re looking to explore, especially being in an urban setting, we have patients that travel up to two hours to come to our clinic, so being able to offer them injectable therapy closer to home would be something we would really strive for.
GLEN PIETRANDONI: Jennifer, did you have something to add for that?
JEN COCOHOBA: I think Taylor summed it up well. I think the need is pushing a lot of clinics, our clinic actually follows a very similar model to Taylor’s, and we’re starting to see a little stretch with regards to appointment slots, injection slots. So it seems natural that the outpouring would be to community pharmacies. But how do we make this work? I think that’s the key question.
GLEN PIETRANDONI: It ties a little bit to the question we received in the chat about first of all Cabenuva is refrigerated for treatment, Apretude for PrEP is not refrigerated. But the reimbursement is the issue. When we in the pharmacy see a prescription for Cabenuva or Apretude we don’t necessarily know yet if it’s covered by the medical benefit or the pharmacy benefit, and that is a real challenge.
Obviously, when it is actually covered, we also don’t know at what rate, because in my experience it is not necessarily always above our cost of goods. Sometimes we literally are getting reimbursed for less than the drug cost, and then you add in all of the support costs of administering that drug, storing it, and everything else.
So if you don’t mind, I’ll go back to Taylor on that. Are you involved in any way of monitoring the profitability of the program from the drug reimbursements to what it costs you to do the work? Or maybe Jen knows this too.
TAYLOR WARD: Great question, and timely question. I’m actually in the process of transitioning to some more managerial relations with our specialty pharmacies in regards to this program, so being able to understand a little bit more of the profitability of this. We definitely track volume that we’re filling at the specialty pharmacy. But I think you make a great point of what does that actually nail down to at the end of the day.
GLEN PIETRANDONI: I guess that relates to a question that just came in regarding having more techs. But, not to beat the drum on reimbursement, but you can’t hire people if you can’t get paid for the drug, and you can’t get paid for the service.
I think if payers were part of a conversation, and maybe aligned with the work that Kathy Byrd has been doing in analyzing the role of pharmacists and getting paid for that value. And she did a great job of quantifying the economic model around supporting viral suppression and the benefit from a cost savings point of view. That’s what the payers need to be looking at, I think.
I don’t know if you want to add anything to that. I thought, being that we worked together on that project, I thought that was the best part, is the economic model.
KATHY BYRD: Thank you. For certain, for a project like the Patient Centered HIV Care Model, for it to be scalable, it is one thing to have good outcomes, it is one thing for it to be cost saving and cost effective. But in order for it to be scalable you have to be able to reimburse the pharmacists.
I should probably mention that Walgreens provided all their services in kind. So we are working with people who were volunteering their services, and that’s just not realistic in the real world. It has been mentioned several times in this meeting so far, we need to find a way to reimburse the pharmacists for their services, for their time and their expertise.
GLEN PIETRANDONI: That I would agree with. Let me see, did another question come in here? There is a question specifically about participating in projects like this, and if grants need to be applied for. I would say yes, I think there are models all over the place that you could put together a program to see if you could get grant funding to stand it up. But the sustainability, I think, is the question.
I have seen, as we’ve heard today, about a couple of rockstar pharmacists around the country that have really proven that they can do it, but I always am the guy pushing back on how sustainable is that. And a lot of times it has to do with local relationships. As somebody mentioned, community acceptance of the program.
I did want to go back, and sorry if I’m skipping around a little bit, but I wanted to go back to the data model and ask if patients individually need to authorize the sharing of the data. Katrease, I think that was, and Rachel. Is that something at the patient level that has to be approving that data sharing, or is that more at the health department, giving access to that?
KATREASE HALE: So once again I think it does depend on how your public health code is written. So in my experience, in Michigan, I have to keep framing it like that because it’s just different everywhere. Since the public health code did recognize pharmacists as providers, and this information can be shared with providers, then individuals did not have to give individual consent.
Now, we could not link them to care, or pass that information on to maybe a medical case management, if they didn’t already have a relationship there, or gave their consent. So the information differed between the pharmacy and the health department until that consent was given to maybe link them to another service, or another provider of some sort.
GLEN PIETRANDONI: Thank you. That was helpful. A couple questions came in regarding any knowledge of reimbursement, any types of sources of funding to help pharmacists offset some of these costs, and Ryan White was mentioned. Any thoughts from any of you on where someone might find funding to support a program like this?
KATREASE HALE: I think some programs are seeking funding through EHE, Ending the HIV Epidemic. And that is through HRSA. However, we funded this entire project, and it is a relatively cheap project to fund, you kind of only need a couple staff members. We funded it completely through rebate dollars.
GLEN PIETRANDONI: Is that 340B rebate you’re speaking of?
KATREASE HALE: Yes. Our state, so through Ryan White Part B, you can recoup funds. Each state has a different level of reimbursement that they get, it looks a little different. And so in Michigan we were really lucky that our state health department funded this through ADAP rebate dollars.
GLEN PIETRANDONI: Great. Someone was asking what receptivity NASDAD is seeing to the data to care model from different jurisdictions. Rachel, do you have any comments on that?
RACHEL BROWNING: People have been really receptive. For those that don’t know, NASDAD is a membership organization, so we actually get to interface with folks from across all 50 states and also seven local jurisdictions.
People are really interested. I would say the biggest challenge is just people being able to assess their infrastructure, especially after COVID-19, the idea of taking on something that wasn’t built into, like EHE plans for example, if your engagement doesn’t already include pharmacists, there are very few folks who already have teams in place to do that work. So for example, with Broward, our main point of contact was trying to do this work since I think he said 2015, and he is just now at a place where he has a team together, people are funded to do this work, has support from NASA, has money to do this.
So I don’t think that people aren’t interested, it’s more just about putting the pieces together, how to kind of work with multiple partners, particularly if you’re not a state health department, how to work with your state officials in order to make sure that you can do something like the Rx program.
GLEN PIETRANDONI: Thank you. And then there was an additional question, Katrease, regarding patients accepting the information once they’ve been ratted out, how are patients accepting this follow-up, I guess you could call it.
KATREASE HALE: I was really surprised when we first started this work in 2015, we started first with Data to Care. And like I said, we kind of did a road show, and I think that year probably talked to 30 different groups of consumers, how do we talk about this. And so one big thing that came back from those discussions is please don’t use the word data.
So on this call we’re talking about it, it’s Data to Care Rx, that’s what we’re calling it. But to the community it’s never referred to as that, it’s called Link-up Rx. And that was one big thing, it’s really off-putting. I thought that there would be a big pushback, because it is kind of scary and it sounds a little scary when you’re like so, we will follow you for the rest of your life, once you’re diagnosed with HIV. And so we had to think about what’s the best way to talk about that. Like we have the opportunity to care for you, different ways you can talk about that.
And so, as we were rolling this out, then we went like a couple years to Rx, and in 2018, we were once again meeting with consumer groups, there was zero pushback. We didn’t get any complaints from people once we had them on the phone. People were genuinely and generally very happy that someone cared enough to help them get their medications, arrange a transport, do whatever might be needed.
And so I’m not saying that would be the same everywhere, but I do think putting in the work with as many groups as you can, so that they have heard about it. And you’re maybe using words and phrases that mean something to the community, is important.
GLEN PIETRANDONI: Great. I always had to struggle with, especially you’re talking specifically about oral medications and measuring adherence. I know there’s a thousand ways to measure adherence. We have always as pharmacists, in my practice at least, have been measuring adherence by the refills, of course. But when you think about mandatory mail programs and the big PBMs that just ship out drugs every 90 days, it looks perfect.
When you’re in the community and you’re really seeing that patient 11 times a year or whatever, we saw the data, and you’re really building a relationship, yes, that person might be 90 percent or 95 percent or 85 percent. But it’s more real, it’s a real number. It doesn’t mean that adherence is better at the mail order pharmacies, it means it’s more accurate I think to see what you’re doing in the community, dispensing when the patient needs it. So I’ve always been struggling with that.
But are there any thoughts, ways that pharmacies could have access to viral loads, and things like that? Because that is the answer to the question we are all looking for as pharmacists. We could dispense the drug, yes, but do we really know if the patient takes it or if it’s effective? I won’t call on anybody, but I’m looking at Jennifer. What are your thoughts on this?
JEN COCOHOBA: I have lots to say about this. I think it’s a strong call, pharmacists in some places, we’re like a silo, we are considered providers in some states, and not in other states. We have access to the antibiotics through some systems but not other systems. And we are considered healthcare providers.
It is challenging sometimes to do the work that we need to do without having a complete picture of what impact the medicines we dispense to our patients are having on them. So I think this is, there are models in which health systems are able to share their EMRs. We do with some of our local pharmacies, and I think that works very well for the pharmacist to be able to look up labs and see viral load.
The other thing I was going to say is that with the advent of some of the newer technologies like point of care testing, urine testing, dried blood spots, hair, other measures of biological adherence I think are quite feasible within a pharmacy that has at least a restroom if you’re going to give a urine sample, but hair is not a biohazard. I think in the future there is going to be a new era of ways for pharmacists to assess what impact antiretrovirals are having on their patients.
KATREASE HALE: I will add one quick thing there. That was one aspect of the program that was like a small nugget, unfortunately we weren’t able to pay pharmacies to be engaged in this way, and I wish we could have. But we weren’t able to.
So we in Detroit used CAREWare, it’s what we used for the management of care information. And so we were able to add the pharmacies that we partner with into that. Which means we have almost a real-time, every two-week update of viral load and CD4s, and so then the pharmacist could see that for their clients if they’re sent our way. And so that was one benefit of this program.
And then earlier, I should have mentioned also another thing is the people on the phone, so at the health department, the person actually calling individuals on HIV, were two people who were represented of the community. It was someone living with HIV, and I think that is also really important, and it was a real benefit to linking people back to care.
GLEN PIETRANDONI: I’m just checking the questions here. One more time.
TAYLOR WARD: I’ve got one over here in the chat. The question is, can you describe what happens in your program if a patient misses an appointment to receive injectables, Cabenuva? So we attempt to schedule all of our patients at the early side of their window, so they get a target date and seven days before that and seven days after that to be considered an on-time injection.
We always try to use those first seven days of the appointment window when we’re offering appointments to the patient, but in the event that there is a snowstorm here, something happens at home, their transportation cancels, they can’t make it to clinic, we have the ability to reschedule in a timely manner.
If they aren’t able to reschedule we will transition them to oral therapy if they’re going to miss their window completely, because then they have their old oral regimen that they were on at home, we’ll do a telemedicine, a visit, so we’ll call them over the phone and kind of advise them on the proper way to start that medication. If they don’t have any oral tablets at home we could send that to the pharmacy, or we could consider using the oral lead-in as a bridge until they’re able to get back into the clinic.
We also have blocks on who can cancel these appointments, because we found that if the patient would just call our generic call center they would reschedule them for the next available, in one month, and that was not acceptable.
So we have blocks that if they’re trying to be cancelled, they have to come to the care team so that we can reach out to the patient right away and get them rescheduled within the right timeframe. We do also ask at every visit that we see them if they have upcoming travel or insurance changes as just kind of a standard question so that we can anticipate some of these things that may happen before they run into them.
GLEN PIETRANDONI: I think we are near the end of our time. I want to give an opportunity for anybody else that would like to make a comment. And if not, I want to thank you all for participating, and it’s great to see some of my good friends after a long absence. Thank you so much. I think I’m turning it over to Mike.
MICHAEL STIRRATT: Thank you so much, Glen. Thank you to another amazing panel. We will now have a short break, and we’ll return at 30 after the hour. Thank you for being here today, and we’ll be back in about 10 minutes. Thanks.
Topic Five: Addressing HIV Syndemic Factors and Co-Morbidities through Pharmacies and Pharmacists
Panel Speaker Introduction
ANGELA LEE-WIN: Good afternoon. Welcome everyone. I am Angela Lee-Win, I’m a program official in the Division of Epidemiology Services and Prevention Research at the National Institute on Drug Abuse. I oversee domestic and international research on HIV prevention and services among people who use drugs. I am delighted to be a part of the NIH planning committee for this meeting and serve as a moderator for this session titled Addressing HIV Syndemic Factors and Co-Morbidities Through Pharmacies and Pharmacists.
People living with HIV are more likely to suffer from HIV-related comorbidities than their peers living without HIV. How can pharmacies and pharmacists help us address this critical issue? How can we learn from successes and challenges, so that we can develop and sustain optimal strategies? And to help us explore these questions together we have five excellent speakers today: Drs. Lewis, Serota, Springer, Stirling, and Edelman.
Dr. Crystal Fuller Lewis is a Laurie M Tisch Scholar for Racial Equity and Mental Health, and an associate professor at NYU Grossman School of Medicine, Department of Psychiatry.
Dr. David Serota is an Associate Professor of Medicine at the University of Miami Miller School of Medicine. Dr. Sandra Springer is a Professor of Medicine in the Department of Internal Medicine Section Of Infectious Diseases at the Yale University School of Medicine.
Dr. Stacy Stirling is a research scientist and co-Director of the Center for Addiction and Mental Health Research at the Kaiser Permanente Northern California Division of Research, and is an Associate Adjunct Professor at UCSF, and an Associate Professor at Kaiser Permanente Bernard J Tyson School of Medicine.
Dr. Jenifer Edelman is an Associate Professor of Medicine and Public Health at Yale University School of Medicine. Please visit the event webpage for short speaker bios.
And just a friendly reminder, we will hold all questions until the end, and open the discussion after Dr. Edelman’s presentation. Please feel free to type your questions into the Q&A box during the presentations and consider stating your affiliation and indicating which presenter can best answer your question. With that, please welcome our first speaker, Dr. Lewis.
Improving syringe access, opioid overdose prevention, and naloxone dispensation among rural and small metro area pharmacists
CRYSTAL LEWIS FULLER: Thank you, Angela. Today, first I want to thank everyone for hanging in there for this two-day session. It is a lot to be on Zoom, and I hope this last session will be informative. So today I am going to talk about feasibility of harm reduction services access among rural and small metro area pharmacies.
I will go back and forth and refer to pharmacies in this location as being either independent pharmacies or non-independent. And I chose that because those that aren’t independent could possibly be chain pharmacies, they could be hospital-based pharmacies. So really my focus is taking a special look at those that are community independent small businesses. And I have nothing to disclose.
But before I get started, I wanted to talk a little bit about what led to this work, for me to venture outside of urban settings, particularly New York, which is very different from the rest of the world, and I recognize that. I’m not a native New Yorker, but I’ve been here for 20 years, since syringe access was passed, legislation was passed in August of 2000, so I’ve been working with pharmacies ever since that.
So with that passage of that specific legislation, we were mandated to do an evaluation, and from that evaluation to make sure this law didn’t do any harm, it led to several studies, and a very close relationship I have with the pharmacy community.
One of our first studies was a large pharmacy randomized community-based trials, which included both independent and chain pharmacies. And just to cut to the chase – But before I cut to the chase, I want to acknowledge Dr. Natalie Crawford who was my partner in crime at this time, she was a doctoral student, and none of this could have happened so successfully without her.
The findings from this trial, basically what we did is we packaged the syringe sale with referrals to treatment, social services, community-based organizations, and really just our first opportunity to see if we could do something in addition to a simple syringe transaction, or just providing medication.
And we found that pharmacies, back then we knew they did want to do more, they do want to do more, and this turned out to not be a heavy lift. One of the worries is that by providing these extra services they would lose their support for this program. And actually, as these findings show, their support for ESAP actually increased in those pharmacies that were asked to do a little bit more beyond the syringe sale compared to those who were not providing any extra services.
And just to tell you a little bit about this study, we had three pharmacy arms that pharmacies were randomized to, one as I described earlier providing the intervention, coupled with all of these materials and information and referrals. One pharmacy that did not give out referrals, but did undergo training to help us collect data, and to help facilitate interviews among persons who inject drugs.
And then because that simple interaction could have been perceived as even an intervention of itself because there was training to go along with that, we had a pure pharmacy arm that received no interaction with the research staff. And those who were in the intervention arm, their support went up. And these are differences between trends. The red dotted line is those who did receive a little bit of training, but not giving out any materials, and those who received nothing, they’re the dark line, and their support went down over time.
And this is baseline, six months, 12 months. And you kind of see these similar trends over time. But a good takeaway I think is just understanding, for many of us who do interventions, just understanding the importance of that contact. And we often don’t see intervention effects because it’s hard to not do anything. And even just interaction with our staff, and working with us, created a more positive perception of the program.
So this was it. This was our big trial. I felt no need to do any more large-scale trials. And so from there we did more unique studies. And I will tell you about a couple of them. Before I do that, that was the impact on pharmacy support, and this is the impact of that same intervention on persons who use drugs.
And you can see here that we looked at a few risk behaviors, receptive sharing, using pharmacies as your primary syringe source, reporting using a sterile syringe every time, pharmacy syringe purchase barriers. And we did see a significant association with reporting 100 percent sterile syringe use for those who received intervention in the intervention pharmacy. So we’re very excited about this.
And then also led by Dr. Crawford, and me just running support. And this was really her idea, when we wrote this grant together, was to see if we could go a step forward with providing HIV testing in pharmacies. But not just HIV testing, but really tackling the challenging issue of stigma, which has come up a few times yesterday and today, and understanding that stigma still is a barrier for many people in accessing services across the board, particularly for black and brown communities.
And what we did is we decided to package HIV testing with what we call normalized screening services, which is cholesterol screening, blood pressure, and glucose screening. And so it was folded all in together, there wasn’t any kind of separation or specialization of HIV. They also watched a video, which we called our healthy lifestyle video, which also packaged all of these chronic conditions together. HIV is a chronic condition now.
And we had two interventions. So we had both video and the packaging, and we wanted to see the impact of the video, because we know videos are very impactful. So we had a video only arm, and then just HIV testing only, and so HIV testing was offered in each of these three scenarios, and three different pharmacies, and they did opt for HIV test when we offered it or decline, and we found that coupling all the bells and whistles of coupling these services did increase HIV uptake, and specifically among those who felt shame and blame.
So shame and blame were the two constructs that we identified through factor analysis that’s really driving stigma in this population. So the interesting thing is when we were analyzing the data we didn’t see an effect, or it was a very weak effect I should say. And I said, why should we think that we would see an effect among people who didn’t report any stigma? I said, let’s just look and see if those who identified, so we cut the sample to among those who just reported shame and blame, and we did see a significant effect.
And so, we’re moving into more and more efforts, but keep in mind these are services that are still for the most part being done by research staff. And so it is really, when you think about it, it was really collocating services for the most part. And in my mind, I knew for sustainability we really needed to see if there was any potential for buy-in or use of pharmacy staff. And I’ll talk about that a little bit later.
And then our most recent trial, or completed trial, we have an existing one now, is right before PEP was rolled out as a treatment beyond in the earlier trials in Bangkok and so forth, PEP was the big-ticket item.
So we wrote a grant to see if we could increase PEP access through pharmacies, and we did this back in I would say 2015, by the time that we got up and running and going. And the interesting thing, PrEP became available during the study, but we still focused on PEP.
The other interesting thing, I don’t present the data here, is that we actually asked many participants what they preferred, because during the study PrEP became available, and we described the two biomedical HIV prevention modalities of taking something at the time of a high-risk event versus taking something on a regular basis. They all said they would opt for PEP.
So PEP was something that we, and I know some of us have talked about it today, but it is a viable option for some people, because maybe they’re not as high risk all of the time, warranting medication to be taken on a more regular basis.
So this study, again, was rolled out over baseline and three months, and we thought well sure, if we create this access, people can come to the pharmacy, they can get a ten-day starter dose but eventually have to go to see a physician.
So we moved all of these barriers, there were a lot of barriers back then. And we also saw a video, we like video, so that was our method of providing education about PEP. Not only about PEP. If you have a high-risk event, come right back here. And these were cherrypicked pharmacies that we got to know in our earlier studies who were very harm reduction minded in these spaces.
And the sad thing is that we had high willingness, at three months, of people saying yes, I would come back to the pharmacy, yes, if this happens I’m going to take this, and we had about three people over the course of two and a half years of doing the study who actually requested PEP, and a couple of them ended up making the request but never followed up because they went into treatment.
Another person got freaked out because they did test positive, and this was the last thing they wanted to do – or they didn’t test positive, they were worried they had tested positive because they knew they had a high-risk event with someone who was known to be HIV positive, lost that person, and another person never followed up. And we had a lot of follow-ups, a lot of effort into trying to bring these individuals back in.
And the beauty of this study, which I didn’t say in the beginning, is that it is a mixed methods approach. So we did a series of qualitative interviews. So in this paper we talk about the context of risk behavior. And what we did is we selected those individuals who reported an extremely high risk event, sharing syringes, maybe a high risk sex partner with somebody who injects, either unprotected sex with someone who potentially could have HIV, they thought could have HIV, and every single one of them said that their risk, it contextualized it, and in their mind it was a high enough risk for them to go on to PEP. So I think we need a lot more time, a lot more effort when we’re talking about biomedical treatments.
ANGELA LEE-WINN: Crystal, please try and wrap up in 30 seconds, thank you.
CRYSTAL LEWIS FULLER: Then we went and said well we got this information about the city, what about upstate New York? So we did 60 of the 80 people we approached upstate to ask about their interest in naloxone and partnering with different agencies in delivering services in the pharmacy, all were supportive. They denied negative impacts. Most of them were multilingual. who were supportive, they supported onsite testing.
But this came with a caveat. Many of them identified a lot of barriers that we saw today. Insufficient support. And limited uptake of naloxone by prescribers and patients. So we haven’t talked about demand. I think the demand for naloxone is also very similar, with issues we’re seeing with PEP and PrEP. We don’t deal with demand. All these structural changes that we’re talking about today will basically fall flat at a patient out of pocket cost for the patient and the pharmacist, and concern over fatalities, as well as stigma.
And then quickly, this is a study that is just coming to close, this isn’t final data, but this is basically a more systematic assessment of both some New York City but a decent sample of pharmacies, mostly independent in the city, and upstate, and we selected the top eight counties where HIV and overdose was highest.
And I want to cut to the chase. There is a lot of interest in on-site services expansion, harm reduction in particular, partnering with different providers, primary care being the highest.
MICHAEL STIRRATT: I am so sorry, Dr. Fuller, but we are out of time. So we will have to go to the next talk.
CRYSTAL LEWIS FULLER: Can I do my final slides and conclusions?
MICHAEL STIRRATT: We have less than 30 seconds.
CRYSTAL LEWIS FULLER: Thirty seconds. I apologize, this isn’t the slide deck I uploaded. We can do this one. Currently underway, what I wanted to bring home is that sometimes it is not location of the pharmacy that’s important, but it’s actually whether they’re independent, community-based pharmacy versus not. And we currently have a study underway that is looking at the feasibility of patient delivered navigation, plus virtual buprenorphine access, coupled with HIV services. And the most innovative piece of this is that it is being delivered by pharmacy staff who have been trained in cultural and structural humility.
We have talked a lot about training, but little has talked about the importance of structural racism, including all of the social determinants that patients and our community that we’ve been talking about serving has not been addressed in doing this in a patient centered way. Thank you, Michael. And I’m sorry, I’m supposed to hand it over, so I will hand it over to David.
Influences on the availability of medications for opioid use disorder in outpatient and inpatient pharmacies in South Florida
DAVID SEROTA: Thank you Crystal. Hi everybody. Thanks for having me. I really appreciate it. My name is David Serota, and I am going to talk about pharmacy related barriers to medications for opioid use disorders in South Florida. No conflicts of interest to disclose.
So my take-home point is that pharmacies and pharmacists play a critical role in securing access to medications for opioid use disorder, which we know are highly effective in facilitating treatment and prevention of HIV among persons who inject drugs.
A little bit of background. So, one in 15 new HIV diagnoses is among a person whom injects drugs, and about one in 10 people living with HIV is a person who injects drugs. To some that is a small percent, but we know that they make up a disproportionate amount of morbidity, mortality, and costs associated with HIV. We have also known for a long time that medications for opioid use disorder are effective for reducing risk behaviors, as well as improving HIV control.
The rationale, I am basically going to be presenting one study that my group published last year, related to pharmacies. So the rationale of the start of this was early in the COVID-19 pandemic we had a student-run free clinic in our medical school based out of our syringe services program, called IDEA Exchange, which you see there.
And during COVID we started transitioning to telehealth, and prescribing buprenorphine by telehealth to people. In Florida, there are a lot of uninsured people, but what we were finding is that even people who were uninsured and willing to pay cash for buprenorphine were having a lot of trouble getting it at pharmacies when they presented with a valid prescription.
Around the same time period we also started an inpatient team that really focused on scaling up our treatment of opioid use disorder, and we were kind of dismayed to find similar barriers to prescribing buprenorphine within the hospital.
So this is just the title of our paper. So our study design for the outpatient pharmacy survey – backing up, I guess, we wanted to basically see what were the barriers to buprenorphine in the outpatient and inpatient pharmacy settings. For the outpatient pharmacies we used a secret shopper audit survey methodology that has been done in a couple of different geographies, published by Lucas Hill. And then for inpatient pharmacies we basically did personal contacts and cold calls to try to gather information.
We were trying to figure out what was the access to buprenorphine in outpatient pharmacies in South Florida. We were looking in Miami-Dade, Broward and Palm Beach Counties. And our main question, the most basic pillar was do they have any buprenorphine in the pharmacy that could be dispensed to a patient with a prescription.
When we looked at inpatient pharmacies, we wanted to know about access to buprenorphine and methadone on hospital formularies, and we also wanted to see if there were any restrictions to who could order those medications.
So we used administrative registries that list all of the outpatient pharmacies registered in the Tri-county Area. We did a similar thing for trying to identify all of the acute care hospitals in our three counties, which was 48. For the outpatient pharmacies, our goal was to sort of accrue 200 successful surveys, and so to get that, we have a 53 percent response rate, and then we tried to contact all 48 hospital pharmacies and were only able to get data from 52 percent.
So essentially, we had a team of medical students, very gung-ho students, I think there were six of them, and they divvied up that list of like 1000 outpatient pharmacies. And they had very strict criterion, they called between 8:00 and 5:00 PM, they pressed one to say they were a prescriber and ask to speak to a pharmacist, and then they identified as a medical student and said I’m working with Dr. Serota and he wants to prescribe buprenorphine to a new patient, and this was the pharmacy they identified, and we just wanted to confirm that you had any available. And so the main outcome was any availability of a buprenorphine eight milligram product, film naloxone Subutex suboxone, any of them.
And the take home message was very bad, only 38 percent had a single dose of eight milligrams of buprenorphine in the pharmacy shelves, or at least told us that they did. We saw across counties there were some differences, Miami-Dade had significantly lower access, or significantly lower rate of stocking buprenorphine than the other two counties. We also found independent pharmacies, like your mom-and-pop pharmacies, were less likely to carry buprenorphine. And we also found that Publix was the least likely of Walgreens, Publix, and CVS Pharmacies.
We also asked, I’m not presenting all of the data from the paper, but there were a number of follow-up questions. We also asked if they had a full two-week supply. Of pharmacies, about 62 percent said we don’t have any buprenorphine, we asked well can you order it, and if so how long would it take to get, and only 55 percent said that they could order it.
On the inpatient side we identified that most pharmacies did have buprenorphine and methadone on their inpatient formulary, but that more than half had what we considered unnecessary restrictions on prescribing. So if you look at the breakdown, most of the restrictions were restrictions based on provider specialty.
That’s what we encountered in our hospitals. So me, an infectious disease doctor, started prescribing buprenorphine, and every order getting cancelled by the pharmacist saying only psychiatrists are allowed to order it, despite that not being the legal rules. So regulations beyond federal laws.
So we really highlighted just two extremely narrow pieces of the continuum of care for opioid use disorder. Just to sort of reiterate, we are answering the question in the outpatient world, is there physically and buprenorphine in this pharmacy? On the inpatient world we are asking, is there any medication for opioid use disorder available, and if a doctor was so inclined, could they order it?
So there are a lot of these different kind of care cascades when it comes to opioid use disorder. I highlighted here just the two little slivers that we addressed in this study.
There was also a lot of work looking at insurance coverage. So, let’s say they have buprenorphine, then it is a whole other story, can a person afford it, does their insurance cover it. I won’t go into detail here, for sake of time, but we know that prior authorizations have an impact on access to buprenorphine. And the survey also done of ADAP programs, relevant to this conference, showed that only 60 percent had buprenorphine on their formulary.
So, overall, I want to inspire pharmacists out there to take ownership of opioid use disorder and recognize how important of a role pharmacies play in access to this HIV treatment facilitator, and HIV prevention intervention. And I will pass off to my good friend Sandra Springer.
Advancing mobile pharmacies to deliver PrEP/ART and buprenorphine and naloxone to People who use drugs in Connecticut
SANDRA SPRINGER: Thank you, David. We didn’t actually rehearse this, but I am so glad you talked about this, because I didn’t put that in there. So thank you. I am coming from Yale School of Medicine, and I am going to talk about work we have been doing on trying to advance really a mobile hub and spoke system to improve access to HIV prevention and treatment medications, as well as, as David pointed out importantly, buprenorphine treatment for those who have opioid use disorder in Connecticut. And the key to this is mobile pharmacies. These are my disclosures.
So the big message is, how can we bring integrated treatment and prevention medications for HIV and in this case opioid use disorder to people who use drugs where they live.
So in addition to us knowing in this country that we are seeing increasing deaths across the country related to the dueling opioid as well as stimulant epidemics, we also know that these epidemics are fueling new infectious disease outbreaks, importantly related to HIV.
This slide is not conclusive, just showing for illustrations that beyond the first case, since the early HIV epidemic of an outbreak in Scott County Indiana that was related to injection of a prescription opioid, oxymorphone, all of the outbreaks since that time have been related to individuals who either inject or use fentanyl as well as previously heroin, and methamphetamine and cocaine, as well as I would say condomless sexual intercourse occurring among people who use drugs, including exchanging sex for drugs and others, in Medicaid as well as non-Medicaid expansion states.
So we know individuals who use drugs are not getting access to medication treatments for opioid use disorder, but we also know they’re not getting access to HIV prevention, PrEP, treatments.
So why isn’t our Ending the HIV Epidemic plan working, importantly, for people who use drugs? It is an excellent plan, it is grounded in excellent science, testing everybody, also for those who have HIV providing rapid potentially same day antiretroviral therapy, achieving viral suppression, undetectable equals un-transmittable. Those who don’t have HIV providing hopefully rapid PrEP.
But the realities are for people who use drugs, unfortunately, there are many, many barriers, including things that we typically expect. So we expect people to come to us to get HIV testing, and treatment, as well as to go maybe to another clinic for prevention if they don’t have HIV. And then because of these silos of care, go somewhere else for your substance use treatment disorder, maybe harm reduction services. We haven’t asked individuals who use drugs why they can’t access these services. So what’s missing is how we can help deliver and help change this delivery system to provide integrated care.
So, through work as an infectious disease and addiction medicine physician, clinically as well as through research that I’ve been lucky to have, been funded for over 20 years from the NIH, we have really identified substantial barriers, many of which have been echoed in the last two speakers’ slides, for accessing medications, in this case PrEP, as well as medication treatment for opioid use disorder for people who use drugs.
Two current NIDA U01s we have one that is actually evaluating the use of mobile health units to patient navigator services to access PrEP, and medication treatments for opioid use disorder for people coming out of the criminal justice system have identified even in our state, a small State of Connecticut, a Medicaid expansion state, that transportation is a substantial barrier.
We don’t have a great public transportation system. I would say it’s not even existent. And we have rural territories in Connecticut where people can’t even get to their pharmacy, or a clinic. There is a lot of mistrust of the healthcare system, obviously stigma has been stated, and stigma related to substance use disorder, substance use, as well as many competing unmet social needs, such as housing, which is a substantial barrier, as well as access to food and phones.
But the other one is, I heard a lot in the last few days that pharmacies are available for everyone practically. But what we are seeing is actually there is a lack of pharmacies in many areas of where people live, or they can’t get to them. And/or they don’t stop the medications, like David was just saying, including injectable buprenorphine, injectable cabotegravir.
And then through our collaborations with pharmacy over many years, including with investigational drug service providing injectable buprenorphine and naltrexone, we have identified ways to actually overcome some of those barriers.
So, providing treatment to individuals who are in prisons or in jails, those who are unhoused, we can do that through certain mechanisms. Also, through our pharmacy collaborators we have learned obviously extensive knowledge about how to actually expand services. And as I will show you next how to actually help change legislation.
So I have been pretty luckily that thankfully NIDA funded this very large, big idea through an Avant Garde award last year, I don’t think it would have passed an R01 or U01, because it is really taking and developing a whole healthcare system.
And so the idea is a mobilized, as I said at the beginning, hub and spoke system, where the mobile hubs actually include retail mobile pharmacies. So not drugs donated via drug company, not mobile vans where you’re just sending a telehealth clinician out to provide a medication, but actually creating pharmacies like your CVS to be mobile and go to people where they live.
Including though importantly people in the community who are coming from those communities that might be affected by overdose, with individuals at risk or living with HIV, trained to provide point of care rapid HIV testing, substance use disorder assessments, telehealth in the moment to bring up a clinician on an iPad.
And then the pharmacist being critically in that group of that rapid response team that can help either bring the patient to the mobile pharmacy that’s in their area or go help get them the medications.
And then the other important thing is not just starting treatment, but helping to retain people on treatment, both for substance use, in this case opioid use disorder, as well as prevention and treatment.
So, as I said, the key is literally to bring the medications to them. That is one of the things we have learned. And so that mobile pharmacy is really key to overcoming those barriers that I’ve identified, and that people who use drugs have identified for us, including stigma and access to pharmacists, where we can actually provide injectable forms of treatment if necessary, and also draw bloodwork or things that might be needed, and have a community health worker who can also help them overcome some of those other unmet needs, including housing applications and other issues.
So, what has that road to a mobile pharmacy been like? I want to just clarify; I did not know when I wrote this that retail mobile pharmacies were illegal. There are no mobile retail pharmacies. So I get the award in June of 2022, immediately talk with our pharmacy colleagues, they say don’t worry, Sandy, we can do this.
And we did, through support with the Connecticut Department of Consumer Protection Division of Drug Control, and also support from Yale New Haven Hospital-Government relations, as well as support from our team, we actually helped write legislation that was sponsored by Senator Moroni and others that actually has now moved past the Senate and the House, and has just been signed by our governor in Connecticut, Governor Lamont on June 7th to now legalize mobile retail pharmacies that are now going to be effective as of July 1 of this year. So that’s great news. So, PrEP, we can do that.
Now, the next challenge is actually getting the buprenorphine. So this is absolutely critical. If somebody needs buprenorphine in the moment, either they’re in active withdrawal, or they’ve identified that they’re craving and need opioid use disorder treatment, we want to be able to do that.
And as David just identified, there are many pharmacies that may not stock medications like suboxone or injectable buprenorphine sublocade. One of the key issues as we found out is that mobile retail pharmacies weren’t an issue, until just now. Unfortunately, the DEA legislation 21 CFR says only mobile vans associated with a brick-and-mortar narcotic treatment program can have controlled substances or stock substances.
We’ve been meeting with them, we actually met with the State DEA, and also Dr. Volkow has been very helpful and supported this work, and NIDA policy offices helped make connections with the Federal DEA, and we just had a conversation with them a couple days ago, which sounds very promising, in allowing potentially for at least this project to have access to buprenorphine so that this now mobile retail pharmacy, your CVS, whatever, but here we’re going to have a partnership with YNNH Hospital Pharmacy can actually dispense just like they would in their brick and mortar pharmacy, dispense buprenorphine from a mobile unit that is controlled in the same way as they would their brick and mortar clinic.
So, now where we’re going. The mobile pharmacy, this is what it’s going to look like. It’s coming August of 2023. We’re already piloting the methods, working with our pharmacist colleagues, also implementation researchers and modelers to help scale up this model to other states once it's going.
So there is a whole group of people to thank. And obviously NIDA, Cynthia Frank, Alysse Schultheis, YNHH, and I would also say Sam Abdelghany is one of the pharmacists that has really been key. Our Consumer Protections Agency, and our state legislature, and many others. So thank you. And I will turn this over now to Stacy Sterling. Thank you.
A pharmacist-delivered primary care telemedicine intervention to increase access to pharmacotherapy and specialty treatment for alcohol use problems
STACY STERLING: Hi, thank you Sandra. I am going to be talking today about a telemedicine consultation intervention for primary care providers and their patients with alcohol problems. And it features clinical pharmacists as the primary clinicians.
And this project is not specifically focused on people with HIV, but it takes place in a general adult primary care setting, but it could easily be adapted to an HIV primary care setting. And the intervention may be especially germane to an HIV care setting, given its emphasis on reducing stigma, and also the vulnerability of people with HIV to unhealthy alcohol use.
This is taking place in Kaiser Permanente Northern California, which is a large integrated healthcare system, and we serve about a third of the population of Northern California. And I just want to acknowledge the National Institute on Alcohol Abuse and Alcoholism for support, and my coauthors.
So, unfortunately, we know that most primary care patients with serious alcohol problems who need more than just a simple, brief intervention from their physician, still really don’t receive the appropriate level of care. And several meta-analyses suggest that SBIRT, or Screening Brief Intervention and Referral to Treatment, is not really as effective as helping this subgroup of people with more severe problems.
Even in the context of Kaiser Northern California, where we have a really established, robust SBIRT program, with about 90 percent screening rate, and 65 percent brief intervention rate, our specialty treatment referral and initiation rates have been quite low.
So the work that I’m talking about really has been designed to address this gap. And NIAAA is very interested, especially in approaches to encourage the use of the effective anti-alcohol craving medications like naltrexone and others which are out there but which are terribly underused.
So this line of work began in 2017 with a small feasibility pilot. And there we wanted to try and use the existing technology that we had in our clinics, and then we had addiction medicine physicians and nurse practitioners who volunteered to help us test out feasibility, and they would join primary care docs and their patients during visits virtually to help guide prescribing and decision making about specialty alcohol treatment. And most often these patients are people who screen positive through the alcohol SBIRT program that I mentioned, but really need more than a simple, brief intervention. But for whatever reason, they have been unwilling or unable to go to specialty treatments.
And we found evidence that the consultation service was very acceptable and valuable to physicians and their patients, and really holds significant promise for increasing the uptake of medications and increasing specialty treatment initiation.
You can see here we did a lot of qualitative work with the providers during the course of and after the pilot, and you can see some of the things that physicians mentioned here. They thought it was valuable, they thought it helped to bridge a gap between primary care and addiction treatment.
We weren’t powered to analyze patient outcomes, but the data that we had suggested that the intervention increases the use of naltrexone and specialty addiction treatment initiation.
There were a number of challenges though, most of them related to logistical and technological things. It was a very sort of clunky hand-off, and this was happening prior to the pandemic, and prior to everyone having shifted over to virtual. So we really kind of cobbled together the technology.
But some of the, they pointed out several modifications to improve the service, including both the primary care docs and the addiction medicine docs suggested using clinical pharmacists to be the clinician delivering the service, because they felt that, they cited their experience using pharmacists who are often used in Kaiser Northern California in primary care and addiction medicine in managing chronic conditions, and they’re highly trusted by their colleagues and patients.
So the next step is that we’re testing in a pragmatic trial is an evolved version of this intervention, using pharmacists. And they are prescribing and managing anti-craving medications, that they use motivational interviewing techniques to help facilitate specialty treatment entry, and they help to guide and support primary care clinicians who are wanting to prescribe these medications themselves. And then we’ve also trained the primary care doctors on the treatment of unhealthy alcohol use in primary care, including pharmacotherapy.
So this is our trial design. And we are just wrapping up this month, actually. It has been about a 20 month long active intervention. We randomized 16 large primary care clinics in our system to usual care, and that included alcohol SBIRT, or to this alcohol telemedicine consultation, ATC.
So that included usual care, but also having these pharmacists available for all of the consultation and training and motivational enhancement that I described in the previous slide.
And so our study aims are to look at, to compare the two arms on implementation outcomes. So we are looking at prescriptions and referral rates over the period. We’re also looking at patient outcomes, so prescription fills and treatment initiation.
And alcohol use, and we have very comprehensive alcohol use measures, because we have such great screening rates in our system. And then health services utilization. And then we are also doing extensive qualitative work with a variety of stakeholders to explore barriers and facilitators to implementing an intervention like this.
And we are using, our data source is the electronic health record, so we can pull very comprehensive data on prescribing and fill rates, treatment referral rates. We have the patient reported alcohol use that I mentioned, demographics and so forth, and services utilization. We are conducting qualitative interviews. And then we also have data that is collected during the course of delivering this consultation service.
So one of the activities, we have partnered very closely with our health system regional pharmacy team on the implementation of this project, which has been just a fantastic experience, and one of the activities that we’ve worked with them on has been the development of a prescribing guideline for implementation into our regular clinical workflow.
So this is a snapshot of just one bit of the guideline, and each one covers the advantages and potential concerns of all of the medications that they might be using. And this guideline was approved by the system’s official Pharmacy and Therapeutics Committee, so once the study is over it will be available to guide the use of anti-craving medications for unhealthy alcohol use across the system.
And then we developed a very comprehensive training curricula for the pharmacist. So introducing them to issues unique to substance use problems and treatment, many of which I would say are also relevant to HIV healthcare, talking a lot about stigma and trauma informed care.
We provide them also with a very strong sense of what specialty alcohol treatment is like, through meeting with addiction medicine clinicians and attending treatment groups so they can really speak confidently with patients, that they might be referring. And then a lot of training on motivational interviewing and enhancement techniques, specifically in terms of alcohol use.
So again, we are just wrapping up, and so these are just preliminary implementation results, but you will see, comparing the two arms, we see a 50 percent higher rate of referrals to care for alcohol problems in the intervention arm. We are also seeing a 13 percent higher rate of naltrexone prescription for people with any alcohol problem, and a 23 percent higher rate for people with an alcohol use disorder. So, promising findings, we’ll see how that goes.
And I’ll just leave you with this: So this is a vignette about a patient who used the ATC service, and the new kinds of experiences that people with alcohol problems can have with these medications. This was a guy who was drinking at least six drinks a night, he had medical comorbidities, he was seen by ATC within 24 hours of his primary care visit, he agreed to start taking naltrexone.
Within a week he reported drinking only one to three beers per setting, and on his final appointment he was drinking about one beer per sitting, on occasion, like a Warriors game. So it just really underscores the speed of the access to care and the benefits of medications. So with that I will turn it over to Dr. Jenifer Edelman.
A pharmacist-delivered intervention to address smoking cessation in people with HIV
E. JENNIFER EDELMAN: Thank you so much, Dr. Stirling. I am going to try and catch us up and motor through. I have no conflicts of interest, NIH funding, and I am a general internist who provides HIV and addiction treatment and have been focusing on research at that interface.
So, the headline is consistent with a few we have had this afternoon: Clinical pharmacists are key partners for developing and evaluating novel strategies to address substance use disorder and other chronic medical conditions in HIV clinical settings.
What is the problem that we are trying to address, with that in mind? Approximately one third of patients with HIV engaged in care smoke cigarettes. And tobacco use shortens life by approximately eight years among individuals with HIV on antiretroviral therapy. So it is responsible for more life years lost than HIV itself when it is treated.
Clinical guidelines recommend the use of the five As, motivational interviewing, Quitline referral, and tobacco treatment medications. The patients inconsistently receive these treatments, and there is need for better approaches to improve abstinence rates.
So while we all agree I think that addressing comorbidities in the context of HIV clinics makes sense, including tobacco use, there are a number of challenges that we identified. First, patients had variable motivation to address their tobacco use. They’re already taking many pills, they don’t want to take anything else, and HIV clinicians, based on our experiences and others, report that they lack time and skill to do this.
Response identified several opportunities, and I will unpack each of these on the next few slides. So first I wanted to incentivize participants or individuals to address their tobacco use. And to do that we used contingency management, which is the use of tangible and timely incentives for achievement of verifiable behaviors.
The goal is to motivate behavior change, especially for behaviors likely to have greater future than present reward, to offset discounting of delayed rewards. So the idea is to make people feel good right now for behaviors where the effects and benefits are longer term.
It is beneficial in decreasing substance use, including tobacco use, and promoting HIV related outcomes. And it builds on our own team’s experiences with using this intervention.
Next, in terms of the principles we use to guide our trial design that I will share with you is we wanted to prioritize nicotine replacement therapy over varenicline. They are both effective in the general population, and safe among patients with HIV.
But there have been limited prior studies that have compared the efficacy of NRT to varenicline to guide prioritization of one treatment over another. Our experiences have shown that, not surprisingly, patients don’t want to take any more pills if they don’t need to. And there are no studies yet that have studied the benefit of switching from NRT to varenicline.
So why rely on clinical pharmacists? Again, a common theme. Integrated models work best, multidisciplinary teams are the norms, and we know clinical pharmacist involvement helps improve HIV as well as other outcomes and providing treatment for tobacco use with clinical pharmacist models in community and clinical settings have been expanding.
We wanted to create an adaptive and scalable intervention, so we used this SMART design, I’ll talk you through that in upcoming slides. And then we really wanted to have an eye toward implementation throughout our study protocol.
This is our team, this is right before we launched, the week before COVID lockdown. And I’ll just highlight here we had to revise our aims. The green text highlights the original design and the modifications due to the COVID impact. Our study aims, and just to highlight that our protocol paper is published in Contemporary Clinical Trials for those who want more details, among 320 individuals with HIV who smoke and are receiving care in one of three health systems, in either Brooklyn, Manhattan, New York, or in Newhaven, Connecticut. We are looking to identify the optimal depth of intervention to promote smoking reduction, to examine the impact on HIV outcomes and look at implementation related factors throughout.
This is our protocol overview. It is a little bit busy. This is a two-stage randomization design, consistent with a SMART design. Participants who smoke who are not actively taking treatment for their tobacco use are randomized in a one-to-one fashion to receive nicotine replacement therapy and counseling with the clinical pharmacist, with and without contingency management.
If you follow the top part of the figure, those who respond to treatment, we continue them, and if they do not respond to treatment we re-randomize them, where we intensify their contingency management reward schedule, or switch them to oral tobacco treatment medications. In each of the two phases, it is 12 weeks, and they have five visits with the clinical pharmacist that they are offered, and outcomes are at week 12.
And just to highlight, at week 12, what is informing whether or not they have responded or not is whether or not they can confirm that they are not smoking cigarettes.
These again are just the components of the intervention offered at different stages, and again it is all with the clinical pharmacist.
Just to note on the contingency management, it is again inspired by the work of the late Dr. Nancy Petry and we used the prize bowl system.
And just to really unpack the role of the clinical pharmacist. So, the design, and the idea behind the initial protocol was informed by what was happening in the clinical settings as well as some informative work we had done in the context of a prior implementation study.
To that end, the clinical pharmacists helped us design the schedule of the visits that we had over the 24-week period, the structure of the visits, the training materials, and the like. And they are the source of the intervention. From an implementation standpoint, we budgeted for their time as part of the NIH award. And they have been incredible partners throughout.
And just to highlight, we go from the research to the clinical care and back, and it has been really exciting to go and do that, so that patients who are enrolled in protocol then can continue with their clinical pharmacist after the protocol ends and there a source of referral, and then thinking about opportunities to advance the field.
I’m going to skip this in the interest of time, just saying we are doing some qualitative work of our own experiences with CM.
And just to summarize, clinical pharmacists have been key partners for innovating treatment of HIV and comorbid conditions in our clinical settings, engaging them in all stages of the research process as we have heard about yesterday and today is critical. It requires flexibility to real-world challenges, so they have had competing domains on their time given COVID and shortages and the like.
And so pending the results of our clinical trial, models that allow flexibility regarding the source of the intervention with partnership with the clinical pharmacists may be helpful. And they have been just wonderful clinical and research partners, it has been just awesome.
I just want to acknowledge our team. We had a follow-up team meeting, and of course it was interrupted by a fire drill. But this is all of us together this spring. I just want to acknowledge funding from the National Cancer Institute for this project, and special thanks to Dr. Annette Kaufman who is our PO. Thank you. I would be happy to take questions.
Questions for the Panel
ANGELA LEE-WINN: Thank you so much for your presentations. I really appreciate your expertise and insights you shared with us today. If you could turn on your cameras for the Q&A, that would be great, and we will now answer some questions and have a discussion.
So, the first question I see is possibly for Dr. Lewis, has on-demand PrEP been explored for injection drug use?
CRYSTAL LEWIS FULLER: Yes. But the problem is it has to be accessible. So right now, New York City, post-COVID, has opened up, launched what they call an express clinic, which is really wonderful, you can access buprenorphine, you can access PrEP, you can access whatever you want virtually.
So a lot of services are available, and just really super successful virtually, for a person to inject drugs, you do not necessarily have that access. And we have to focus on demand. I don’t think we’re asking the right question.
I don’t think there is a huge demand for PrEP among black and brown persons. And if we don’t pay attention to that, all of this work is for nothing. It’s worth it, it’s for stuff, but we’re not getting to the populations who have been underserved, and that’s my big push.
ANGELA LEE-WINN: Any other comments from the panel?
SANDRA SPRINGER: That has obviously been one of the areas we have been working on, is trying to improve the immediate access when people want it, where they are. And importantly, populations that we are working with are those coming out of the justice, criminal/legal system, PrEP is not being offered to them, and they have a lot of unmet needs, as well as people who are using drugs who are unhoused, and others that are in the community, it’s not being offered. So we are trying to be able to provide that education and those services to people when they want them, where they need them. And so it is a huge need that needs to be filled in.
ANGELA LEE-WINN: The next question is about the challenges, about the long queues which lead to longer turnaround time in a rushed service when it comes to pharmacy centered work.
CRYSTAL LEWIS FULLER: I’m sorry, what is the question?
ANGELA LEE-WIN: The question is about the challenge of the long queues which lead to longer turnaround time in a rushed service.
CRYSTAL LEWIS FULLER: Long queues, like wait times to be served in a pharmacy? Like, you go to the pharmacy and there are long lines?
DAVID SEROTA: I can speak to that a little bit. I think a lot of times the people that we send prescriptions for who get turned away, there are a lot of barriers to them interacting with the healthcare system, including community pharmacies.
And sometimes it’s like their medication was ordered without the diagnosis code attached, and that takes it away from the insurance accepting it, and there is just not a lot of time for community pharmacists to be navigating that and taking ownership over it and trying to troubleshoot it.
I’m trying to spread the word among my local pharmacists that they should and that this is really important, and turning someone away who is on buprenorphine and saying you can’t refill your prescription could be leading to their demise in a matter of days if they return to drug use. And so I try to educate on thinking of it like insulin in a type one diabetic, we need to be doing everything we can to get access to this, rather than sort of passively turning people away or pushing them off to the side, I guess.
ANGELA LEE-WINN: Next question is how does the implementation of pharmacy mobile units and the like impact local NGOs and agencies who receive funding based on testing capacity and PrEP distribution?
SANDRA SPRINGER: Obviously I will take that. The whole point is that people aren’t actually getting treatment, but we work with all of the community agencies, the Department of Public Health, to identify where deserts are, where people, maybe there are services, but they’re not linking to them, or they aren’t aware of them.
So the way we see it is it is actually a retail pharmacy. So if you are working with agencies and you want people to get PrEP, or you want them to get naloxone, or you want them to get services, it’s another avenue where you could just send your prescription, you can send your people to this mobile pharmacy, so it wouldn’t interfere with what they’re doing and potentially could help them.
I think one of the things that we’re learning is unfortunately there are all these silos in care, and we really need to be bringing people together and helping people. And there are a lot of people, it is hard to navigate, where to go, where do I go. And the stigma as we said is substantial.
So the whole point is that retail pharmacies, again, they’re brand new, they will be brand new in Connecticut, are trying to fill in those gaps. And for us in particular it is really trying to provide services that people who use drugs really need.
And really, it is not just parking a mobile pharmacy there and expecting them to come, but actually going to where they live. It could be living in a park, living wherever, so really expanding that and trying to help agencies that are trying to expand testing, it’s trying to expand treatment to get to those people and help them stay on treatment.
ANGELA LEE-WINN: Any other comments from the panel?
CRYSTAL LEWIS FULLER: I think the mobile pharmacy is novel, and that sounds really exciting. But we have provided education. Again, I can’t wait to see the results, because you can break down all of these structural barriers by getting people to go on PrEP. We’re still talking about this, and it has been almost 20 years, and we’re not focusing on that. There are people who just won’t do it. We saw it with COVID. And there are clear reasons that we’re not thinking about, we’re not addressing, and it's steeped in structural racism.
SANDRA SPRINGER: We are actually seeing that in the study with trying to get people that are coming out of the criminal justice system, to help them get access to PrEP, and it is not at the top of their needs, there are other unmet needs, education, but racism definitely, a lot of other issues. And it’s not just access to meds. So we’re actually training people who are living in the communities, so the people who are affected by overdose with lived experience to actually provide HIV testing, if they want it, provide substance use disorder assessments if they want it.
But really it’s not just providing those medications, it’s providing whatever it is that they need. So it may be a diabetes medication, or hey, can you check my blood pressure, or I can’t get housing, can you help me? So it is actually helping provide those services. Drug testing, we’re going to be providing fentanyl, xylazine test stripes, naloxone, all of those things, and help link them with whatever they need in the community.
But yes, I completely agree with you that that PrEP readiness, that understanding, that part, it’s not going to be instantaneous, and it is going to need all of us to help improve education and access to services. I think that’s a big area.
ANGELA LEE-WINN: Possibly the last question before we end our session. We have a question on staffing. Mostly pharmacists and private pharmacies are left out in HIV pharmacovigilance trainings. It would be great indeed, to have HIV pharmacist prescribers to implement these amazing interventions. Would anyone like to comment on that?
SANDRA SPRINGER: Actually, what happened in Connecticut just now, in addition to the bill, the SB1102, we had a small part in it in mobile retail pharmacies, but the other part that was just passed, as of July 1 pharmacists can actually do HIV testing and prescribe PrEP. And then obviously the implementation of that with collaborative care agreement.
So that is something that is going to be advancing. I heard other speakers over the last two days talk about that. I do think that is a critical area, but with guidance from clinicians, including repeat testing and other things.
ANGELA LEE-WINN: Any final comments or suggestions for future directions you would like to share? With that I’ll close this panel session. Thank you again for your presentations and participation. I will now hand it over to Dr. Sarah Read, from NIAID Division of AIDS for the closing session. Thanks everyone.
Closing Session: Looking to the Future
SARAH READ: Thanks so much, Angela. Good afternoon, everyone. I’m Sarah Read, I am a Deputy Director of the Division of AIDS in the National Institute of Allergy and Infectious Diseases, and we and NIAID are really pleased to have been a partner in this important meeting, and it is now my pleasure to open our final meeting segment.
Very briefly I would like to first offer my sincere thanks to all of the organizers and speakers on our very stimulating meeting. Over the last two afternoons we have covered a lot of ground. I am struck by how wide ranging the presentations and discussions have been.
And I think that this reflects the remarkably wide-ranging contributions that pharmacists can make in HIV across a variety of contexts and populations, and it shows how important they are to a comprehensive strategy on HIV.
As we conclude our meeting, we want to further consider the way forward and unique contributions that NIH can make by advancing research on the topic. So in that regard, let’s now turn to our rapporteurs report. We are fortunate to have Walid El-Nahal from the NIMH Office of AIDS Research, who will provide a summary comment from this meeting with an eye toward the critical next steps we must take with our research. Thanks everyone for your attendance and participation today, and Walid, I pass to you.
Bringing It All Together: Reflecting on Research Gaps and Opportunities
WALID EL-NAHAL: Thank you very much. Hello, everybody. My name is Walid, I’m from the NIH Office of AIDS Research, and I today have the somewhat un-enviable task I think of trying to take these eight hours of incredible talks that we’ve heard today and really distill them down into just a few minutes, to help us all kind of take a step back and look at the big picture of all of the incredible work that is being done in this space, and ask the question of okay, what’s next, kind of what do we do from here, given what we know and what we have all shared over the course of the last two days. So with that I will move into my summary of the last couple days.
So briefly, an outline of what I’ll be talking about. First, I’m just going to go over again some of the potential of pharmacies to provide HIV care, which is really the framing of this conversation and why we all think that this work is so important.
Then I’ll move into talking about some of the existing momentum for pharmacy-based HIV care, kind of a lot of the excitement that we saw reflected in the talks that we’ve seen these last couple days. I’ll spend a little bit of time going over the current research landscape as it was presented in the talks that we saw today and yesterday. Then I’ll move into some of the barriers to HIV care in pharmacies, which we have heard kind of reiterated throughout the talks, a lot of common themes that emerge.
I’ll then move into the need for some future research. Obviously, the NIH’s sponsoring of this meeting, we’re a research-oriented organization, so we are very interested in trying to understand kind of what direction the research should move forward from here, and how we can kind of help support that.
And then lastly, I will wrap up with kind of a summary of the big picture and talk briefly about opportunities moving forward.
So first I just wanted to open with this word cloud which kind of was a reflect of you all’s input yesterday during one of the first breaks in the meeting, and I wanted to bring your attention to that central word in the middle, which is access, which I think a lot of people agree is kind of one of the biggest advantages of trying to leverage pharmacies as a means of providing HIV care.
And so just to reiterate some of the important things that people have brought up over the course of the last couple days as was mentioned, there are 60,000 pharmacies across the United States, 90 percent of the US population live within five miles of a community pharmacy. And the visual demonstration of that I think is in some of the maps that were presented yesterday. You all can see the blue dots representing pharmacies in comparison to the yellow triangles, which is current PrEP prescribing locations.
And then that is not only something that is true domestically, it is also true internationally, when we were looking yesterday at the map of Kenya, you can see the red dots demonstrating the proliferation of pharmacies and their wide availability in access.
So there are thousands of pharmacies, and many of them are also in underserved areas. But again, not all areas, as was mentioned by one of our speakers, yesterday. And so these pharmacies by virtue of their wide access provide an opportunity to address a lot of inequities.
They also have accessibility at convenient hours. They present kind of an opportunity to implement cost-effective interventions. We heard yesterday from one of the speakers that every dollar spent on these pharmacy-based interventions could potentially save up to $3 in care for people living with HIV.
And then of course there are lots of lessons learned about pharmacies during the COVID-19 pandemic, as we all know there were millions of vaccinations administered during the pandemic through pharmacies, which administered over 50 percent of all vaccinations in the United States, and tens of millions of COVID-19 tests were also administered through pharmacies, which I think again just reiterates the value of pharmacies and pharmacy-based care as a means of delivering care to our patients.
So, with all that in mind, and kind of framing the conversation of all the reasons why we think, and I think a lot of people on this meeting agree that pharmacies have tremendous value in this space, and being an avenue for HIV care, we saw there is also a lot of momentum around this idea that has been growing recently. So as mentioned yesterday, 15 states have authorized pharmacist prescription of PrEP and PEP, there are bills in about 13 more states, so that’s rapidly growing.
There was a mention of the pharmacist role in the national HIV/AIDS strategy, in what was described yesterday as the Mighty Box Six of the strategy, talking about kind of the importance of pharmacies for really having a comprehensive plan to end the HIV epidemic. The US Public Health Service yesterday talked about their EHE Pharmacy Task Force.
We heard yesterday and today the perspective of advocates on behalf of the community, as well as nonprofit groups. We also heard from the US Business Action to End HIV Coalition, which is a coalition of businesses, and they mentioned their recent roundtable around this topic. And then of course we’ve also heard a lot around the growing literature on the use of pharmacies for HIV care, including kind of this meeting, which is again, by virtue of being a research focused agency, a meeting the goal of which is to highlight some of the research that has been done, and think about some of the research that needs to be done to really move this space forward.
So, getting into that research a little bit, I’ll talk briefly about some of the research landscape. We’ve talked about why there is this strong belief in the potential value of pharmacy-based care, and we talked about how many different groups and sectors share that belief.
So what does the current research landscape actually look like? Here are some of the examples of research and real-life applications that we’ve heard about over the course of the last two days. And by virtue of the time constraint, I am not going to be able to talk about every amazing example that was presented, but I’ll just highlight some.
So we heard yesterday during a presentation that there is qualitative data that demonstrates the interest of patients and the willingness of pharmacists with training to provide HIV care. We saw examples of pilots and multi-center studies that demonstrated the successful screening of hundreds of participants for HIV. And one of their studies had mentioned that they were able to reach, the patient population that they reached, 42 percent of them had never been tested before.
So through pharmacies we were able to reach populations that we haven’t historically been able to reach consistently. We saw real world examples, including a corner pharmacy that was offering PrEP counseling, testing, and prescriptions to thousands of patients, in person and virtually, for both oral PrEP as well as long-acting injectable PrEP, which many of you know has been kind of a challenge to implement in clinics.
In rural communities we saw the example of how tele-PrEP studies can extend the reach and coverage of PrEP. So populations that we have not successfully consistently engaged otherwise.
We saw collaborations between academia, community, and retail pharmacies to increase PrEP among populations with disproportionately low uptake, including racial and ethnic minorities. We saw folks leverage multidisciplinary work with teams that included nurse navigators, pharmacists, and remote physicians to increase PrEP access.
And we saw training pharmacists in medication therapy management of HIV to increase the proportion of virally suppressed people with HIV. We also saw investigations of pharmacies as an avenue for long-acting therapy for HIV, which again has been a real challenge to get out into the community. Big barriers for many clinics to administer, so to see that success in the pharmacy space was really great.
We saw several examples of large retail pharmacy programs, including testing campaigns, no-cost testing vouchers, PrEP programs, et cetera. We saw various pilots, which are growing into ongoing trials of accredited drug dispensing outlets to facilitate self-testing among young women in Tanzania. And we saw pilots and ongoing clustered randomized trials demonstrating the potential of pharmacies as PrEP delivery pathways in Kenya.
And so taking a step back, and I hit you with a lot of examples because we saw a lot of incredible examples in these last two days, taking a step back and looking at the big picture of this, I was struck by several features of all of the research that we saw.
First, there is a ton of research design diversity. We saw qualitative work, implementation science, prescription data, pilot studies, randomized cluster trials, geographic analyses, policy assessments, and a whole range of different analyses trying to look at this from different angles. There was lots of outcome diversity looking at prevention, mainly focused on PrEP, screening or testing, linkage to care, implementation outcomes, looking at stigma, looking at syndemic conditions, et cetera.
There was diversity in the target populations as well as geographic diversity. So there was kind of investigations that look at MSM, women living with HIV, adolescents, and young adults with HIV. But of course we also want to continue to expand the groups that we are including in our trials, including these groups as well as various other groups, including for example transgender individuals.
And then there was also work that was done domestically, spanning across multiple states. And we also saw multiple examples of international work, spanning across multiple countries, which for me really highlighted that the leveraging of pharmacy-based care is something that is universal and really has potential all over the world.
And then we also saw a broad range of collaborators, from academia, community and retail pharmacies, local state and federal government, community-based organizations, nonprofits, et cetera. The list goes on and on, which was great to see.
So this growing body of data that we saw a sampling of these last two days really suggests that HIV pharmacy-based care is of interest to patients, it is highly feasible, it is effective for reaching a higher proportion of the population, it can be cost and time effective, it can be stigma mitigating, and so it has many kind of benefits.
But, that being said, it is of course not perfect, and there are several barriers to pharmacy-based HIV care. And some of those barriers that we have heard over and over again as a thread throughout multiple of the talks was: The issue of scope of practice for pharmacists. The issue of workforce training.
The scalability and sustainability of some of these interventions. How do you reimburse for this really important work. The fact that although pharmacies are very accessible and available in lots of areas geographically, there still are pharmacy deserts that still disproportional affect certain communities.
How do you implement these interventions. How do you facilitate testing that’s needed for things like HIV screening or PrEP administration in pharmacy settings. How do you go about promoting healthy behaviors and ensure that patients actually are taking advantage of these interventions that we’re trying to offer.
And then how do you link patients to care if you determine if they in fact do have HIV or do need kind of an escalated level of care. And then how do you integrate these interventions seamlessly into the workflow so that they are efficiently implemented in practice.
And then lastly, kind of how do you balance all of this and this really great opportunity to offer care in another avenue while also balancing that against pharmacists’ bandwidth and making sure that we’re not kind of over-burdening our providers who are already obviously very busy in the work that they’re doing.
So as a research agency we always want to take these barriers and flip them on their heads and ask well, they’re barriers now, so the research that we need to do is how do we overcome those barriers, what are the questions that we need to ask, and what are the answers that would allow us to get around these barriers and surmount them.
So, I have listed here the barriers again, and I’ll just go through some of the questions that naturally come out of them. The barrier of how do we implement this, you have to think about how do you best implement pharmacy-based interventions, and recognizing that the context differs, you have your large retail pharmacies and you have your smaller community pharmacies. The resources differ, the patient needs differ. So how do we implement interventions successfully in different contexts.
And of course, not only looking at implementation outcomes, but also looking at how do we think about effectiveness outcomes, to build on the body of literature that already demonstrates how effective pharmacy-based HIV care can be. And we saw today a great example of hybrid design for both types of implementation and effectiveness outcomes.
Next, how do we develop newer testing technologies, and how do we better leverage the ones that we already have? How can behavioral science support some of these pharmacy-based interventions, and how can we design them in a way that centers the person and ensures that our interventions are acceptable and even appealing to the people that we’re trying to reach? And also how do we make sure that we’re doing this work in collaboration with the communities that we want to serve and ensuring that they are partners in the work and benefiting from its results?
Then, what is the best way to ensure linkage from the pharmacy, and also how do we build partnerships between the pharmacies and for example the health departments, or the academic clinics, or the various other places where we want our patients to kind of continue to be seen and continue to receive therapy? How do we most efficiently integrate these interventions into the pharmacy workflow? And again, this is going to need robust implementation science and behavioral science to ensure that we’re efficiently building interventions into the workflow.
And then how do we support pharmacists in this critical work, recognizing that this is an increased demand on their bandwidth, and how do we best leverage the other resources and staff in the pharmacy, like pharmacy technicians, nursing staff, administrative staff, et cetera, to make sure that our pharmacists are feeling supported and able to do this work without interrupting other duties that they have?
Then thinking about, for the scope of practice question, what policies facilitate successful pharmacy-based interventions? Now, as federal staff obviously we can’t be advocating policy positions, but just to mention this important question that came up over and over again, over the course of the last two days.
And separately, to kind of use the word scope differently, what is the scope of pharmacy-based HIV care? What important comorbidities can we address? So for example today we just heard a great deal about the efforts to treat substance use disorder, and some of the challenges and successes that come with that when you’re expanding beyond just the treatment of HIV itself.
On the question of workforce training, how do we effectively train a multidisciplinary team to deliver and investigate pharmacy-based interventions? And then for scalability and sustainability, how do we scale these interventions up across different local contexts, again recognizing that those contexts can be very different in the resources available, et cetera? And how do we do that in a way that is sustainable?
And to the question of sustainability, I think the point of reimbursement was always the response to that over the course of these last two days. So what is the cost effectiveness of these interventions, and how does that tie into reimbursement, which several people have mentioned would be really important to ensuring that these interventions are continued long-term, and actually implemented widely?
And then lastly, we also talked about pharmacy deserts. So where are the pharmacy deserts? And not only kind of pharmacy deserts are kind of, the geography of pharmacies is really only one dimension of the social determinants of health that differentially affect different groups within our patient population.
We have to recognize that the pharmacy deserts is just one element of social determinants of health. So how do we address that and ensure that we’re centering equity, which is a point that Dr. Crawford made very well yesterday, and to make sure that we’re conducting inclusive, culturally competent research that results in us narrowing some of the healthcare inequities that we have all become very familiar with.
So, in summary, kind of well over time here so I will wrap it up. Talked briefly, the summary of what we heard and the opportunities moving forward, and the big picture. Again, we all agree that pharmacy-based HIV care has tremendous potential to improve health, we’ve heard that over and over again these last two days. And people from many sectors are very motivated to advance this type of work, which is why we have 200 participants on the call right now.
Very talented people are studying and implementing this already. And the body of literature around it is growing, and it is proving its value. But there is plenty of room to grow, and several barriers to overcome as we just talked about. So how can we all in our respective roles help overcome those barriers?
Obviously at the NIH, again, we are a research-oriented agency, so our goal from this is going to be trying to walk away and internalize all of the stuff that we talked about today, to really think about what are the next steps, and how can we support the research that’s going to advance this type of care delivery moving forward.
And for you all, in your respective roles, we obviously encourage you to think kind of what can I do in my respective role to keep doing this really impactful work and expanding it moving forward.
And so that is a summary of all we have, and I apologize I went over a few minutes, but I was trying to condense tremendous work that people have been doing and presenting over the course of these last eight hours, into a very short time slot. So with that I will go ahead and pass it over to Mike.
Idea Collection Invitation and Reminder
MICHAEL STIRRATT: That was great. I am going to pass to Dianne Rausch for a final comment, and then to Paul Gaist. Thank you.
Note of Thanks
DIANNE RAUSCH: Thanks, Mike. I just want to say thank you from NIMH to all of you who participated in this meeting. It has been really exciting to hear about all of the different programs and the creative ways they have been utilized to integrate pharmacies and pharmacists into managing HIV prevention and treatment efforts. These discussions have generated lots of new ideas, and we are hoping that moving forward we can build on these ideas and expand opportunities to improve healthcare for our clients. I think Wally did a great summary of where we are going and what we need to do, and we look forward to next steps. And with that I will turn it over to Paul Gaist from OAR to close us out.
PAUL GAIST: Thank you and your Institute for the frontline role that it has played in bringing this meeting to fruition. Dr. Kapogiannis, Director of the NIH OAR has asked me to give these closing remarks. To all involved in this meeting, from planning through to presenting, moderating and attending, thank you all for making us an important and timely meeting, bringing together key partners to consider and discuss the current landscape, and where we should be headed in research and practice in the HIV and pharmacy space. As we just heard so well summarized, in Dr. El-Nahil’s excellent rapporteur report out.
Concretely on next steps. As soon as we can, we will prepare and post the presentations from this meeting online for your future viewing and use. The NIH HIV Pharmacy Planning Group will convene to distill and discuss what has been presented here to consider how best to further disseminate the outcomes of the meeting, as well as to formulate next steps in our research planning and opportunities.
We also encourage you to answer the question Dr. Stirratt presented in his opening remarks this morning, as has been put into the chat today. Your input as you can see should be sent to DARCommunications@Mail.NIH.Com. Before we close, I would like to acknowledge Dr. Stirratt, and all the members of the NIH HIV Pharmacy Planning Group for the thought, planning, work and commitment that has gone into making this meeting such an important success. Thank you, and I wish each and all of you the best as you go forward in your work. I hope you all have a wonderful holiday weekend, and we are adjourned.