HIV/AIDS
Featured Studies
Featured studies include only those currently recruiting participants. Studies with the most recent start date appear first.
MyPEEPS Mobile for Young Transgender Men
Study Type: Interventional
Start Date: June 30, 2023
Eligibility: Females, 15 Years to 19 Years, Accepts Healthy Volunteers
Location(s): Columbia University, New York, New York, United States; Callen-Lorde Community Health Center, New York, New York, United States; Ann & Robert H. Lurie Children's Hospital Chicago, Chicago, Illinois, United States
Transgender youth in the United States have unique health needs but often face barriers to accessing and receiving health care services which contribute to disparate health outcomes, including high vulnerability to HIV and other sexually transmitted infections. The proposed MyPEEPS intervention for young transgender men is a novel and evidence-driven intervention using mobile technology to deliver HIV prevention information to high risk youth. The final product will be the basis for conducting a large-scale efficacy study in this population.
1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV
Study Type: Interventional
Start Date: April 30, 2023
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Johns Hopkins School of Nursing, Baltimore, Maryland, United States
This study tests a 7-session cognitive behavioral approach program (herein referred to as the 1MoreStep intervention) to train out-of-care Black women living with HIV (LWH) and exposed to intimate partner violence (IPV) in the past 2 years (hereafter, BWLWHI) in: 1) cognitive and behavioral skills to access internal and external sources of strength (e.g. self-reliance, safety net); safety strategies, knowledge about Undetectable = Untransmissible (U=U) and HIV care; and reduce internalized and anticipated stigma; 2) communication skills to respond to enacted HIV and IPV stigma and enlist social support; and 3) addressing structural barriers to HIV care engagement with an HIV navigator component. The intervention is informed by the HIV-Stigma Framework and a resilient-reintegration model which views women as active participants in responding to IPV and managing life with HIV.
Aim 1: Examine preliminary efficacy of the 1MoreStep intervention on: (a) IPV safety strategies (informal and formal resources, safety planning, and placating strategies at baseline and 3-month follow-up visit); and (b) HIV care engagement (medical record confirmed visit with an HIV care provider, antiretroviral therapy [ART] prescription, medication adherence, and viral load status during 3-month follow-up period).
Aim 2: Examine the acceptability and feasibility of the 1MoreStep intervention operationalized by (a) quantitative measures: session attendance and fidelity to key intervention components and (b) qualitative interviews to assess: program fit, facilitators and barriers to participation, and using 1MoreStep intervention skills.
LetSync: Pilot Test of Mobile Health (mHealth) Intervention
Study Type: Interventional
Start Date: March 15, 2023
Eligibility: Males, 18 Years and Older, Accepts Healthy Volunteers
Location(s): University of California San Francisco, San Francisco, California, United States
The Pilot Test (AKA Study B) will entail a pilot randomized, controlled trial (RCT) of an mHealth behavioral intervention, LetSync, with 80 couples (N=160) to assess its acceptability, feasibility, and preliminary impact on retention in care and ART adherence as measured by antiretroviral concentrations in hair. Participants in the intervention arm will use LetSync v1.0 for 6 months and provide acceptability and feasibility data. In the ensuing 2 months, the investigators will make refinements based on participants' data to produce LetSync v2.0. Then, participants in the waitlist-control arm will receive LetSync v2.0, use it for 6 months, and provide acceptability and feasibility data. The intervention arm will continue using LetSync v1.0, for a total of 14 months. Based on acceptability and feasibility data from waitlist control arm participants between T3 and T4, the investigators will develop LetSync v3.0, which will be used for efficacy testing in a full RCT trial in the future.
Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV
Study Type: Interventional
Start Date: March 3, 2023
Eligibility: 18 Years to 70 Years, Does Not Accept Healthy Volunteers
Location(s): Massachusetts General Hospital, Boston, Massachusetts, United States
This study will determine the effects of pregnenolone on brain function, inflammation and depressive symptoms in people living with HIV who have depression. Participants in this study will receive a pill of either pregnenolone or placebo, and can stay on their current antidepression medications. Brain imaging and behavioral assessments will be performed during the study.
Feasibility of Positive Links for Youth Care Engagement Intervention
Study Type: Interventional
Start Date: February 2, 2023
Eligibility: 18 Years to 29 Years, Does Not Accept Healthy Volunteers
Location(s): University Health Center Downtown, San Antonio, Texas, United States
A small pilot study to assess feasibility and acceptability of the PL4Y intervention.
Personalized Prevention for Couples
Study Type: Interventional
Start Date: January 11, 2023
Eligibility: Males, 18 Years and Older, Accepts Healthy Volunteers
Location(s): University of Michigan, Ann Arbor, Michigan, United States; Florida International University, Miami, Florida, United States
This web-based application, couples-based HIV/STI prevention intervention project will determine efficacy to reduce HIV/STI incidence via uptake of evidence-based strategies and a tailored prevention plan among male couples who are in a relationship (defined as greater than 3 months or more).
Extension of SEARCH SAPPHIRE Dynamic Choice Prevention Study
Study Type: Interventional
Start Date: January 2, 2023
Eligibility: 15 Years and Older, Accepts Healthy Volunteers
Location(s): IDRC Southwest Uganda, Mbarara, Uganda; GPRT / SEARCH Office, Kisumu, Kenya
The overall purpose of this SEARCH SAPPHIRE CAB-LA (Cabotegravir Injectable Suspension) extension study is to 1) Determine if adding the option of CAB-LA as a prevention choice using a patient-centered HIV (human immunodeficiency virus) prevention delivery model increases prevention coverage compared to the standard-of-care in three ongoing randomized trials of Dynamic Choice Prevention in rural Uganda and Kenya; and, 2) Conduct a hybrid implementation study (Primary Objective Clinical and Secondary Objective Implementation) focusing on initial implementation of a patient-centered model for CAB-LA using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) evaluation framework among persons randomized to the intervention arms.
PositiveLinks: mHealth for DC Cohort
Study Type: Interventional
Start Date: December 12, 2022
Eligibility: 16 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Unity Medical Center, Washington, District of Columbia, United States; Georgetown University, Washington, District of Columbia, United States; Medstar Washington Hospital Center, Washington, District of Columbia, United States; La Clinica Del Pueblo, Washington, District of Columbia, United States; Howard University Hospital Pediatric Clinic, Washington, District of Columbia, United States; George Washington Medical Faculty Associates, Washington, District of Columbia, United States; MetroHealth, Washington, District of Columbia, United States; Washington Health Institute, Washington, District of Columbia, United States; Family and Medical Counseling Service, Washington, District of Columbia, United States; Whitman-Walker Health, Washington, District of Columbia, United States; Howard University Hospital Adult Clinic, Washington, District of Columbia, United States
To achieve the end of the HIV epidemic, concerted efforts will be needed to address the HIV care continuum, including improving retention in care (RIC) and viral suppression (VS) among persons with HIV (PWH). In the U.S., less than 50% of PWH are RIC and even fewer are VS. Studies have shown that these PWH have poorer clinical outcomes and are at risk of transmitting HIV to others, hence the need for innovative solutions to improve retention in care and subsequent viral suppression. Theory-based mHealth interventions have been shown to be promising in reaching these at-risk groups and improving HIV-related outcomes. PositiveLinks is a clinic-deployed mHealth platform that includes patient and provider smartphone apps, a web portal for clinic staff and providers to manage patient cohorts, an online implementation guide, and a learning management system to train and certify clinic staff. It has theory-based features including daily queries of adherence, mood, and stress, graphical feedback for self-monitoring, secure messaging with staff, appointment reminders, anonymized peer support, information resources, and document upload capability to support insurance re-enrollment. A 12-month prospective study in poorly retained PWH found that PL increased RIC and VS, with app use related to benefit as well as improved social support and stigma. PL is a promising existing mHealth tool for PWH, yet its efficacy has not been tested in a randomized trial, nor in urban populations. The investigators will test the efficacy of PositiveLinks to improve RIC and VS among a cohort of PWH in a high HIV prevalence city of Washington, DC. Participants will be identified from the DC Cohort, a longitudinal prospective cohort of PWH receiving HIV care at 15 clinics in DC. First, the investigators will conduct formative research to assess the feasibility, acceptability and usability of PositiveLinks among this urban cohort and conduct subsequent adaptations based on these findings. The investigators will then conduct an efficacy study through a cluster randomized controlled trial at 12 DC Cohort sites among 482 PWH. Clinics will be randomized to PL or usual care. Primary outcomes will include VS, RIC, and visit constancy at 12 months. Finally, the investigators will conduct mixed methods implementation science research guided by the Consolidated Framework for Implementation Research and RE-AIM to identify site, patient, provider, and system factors that characterize best practices in program implementation. If successful, this research will lead to the development of a novel and efficacious approach to improving RIC and VS among PWH which could lead to dissemination research that will contribute to HIV epidemic control. This project is responsive to NIH priorities, National HIV/AIDS Strategy, and Ending the HIV Epidemic goals as it is cross-cutting, seeks to reduce health inequities, and to improve health outcomes to achieve sustained viral suppression in a geographic hotspot for HIV.
Integrating U=U Into HIV Counseling in South Africa
Study Type: Interventional
Start Date: November 21, 2022
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Primary Health Clinic B, Johannesburg, Gauteng, South Africa; Primary Health Clinic A, Johannesburg, Gauteng, South Africa
The near-elimination of HIV transmission with antiretroviral therapy (ART) has provided the world with a clear path to end the HIV epidemic through the mass provision of ART at diagnosis, i.e. test-and-treat. Despite the substantial prevention benefits of ART, the investigators found minimal knowledge of treatment-as-prevention (TasP) in two population-based surveys recently conducted in South Africa. In addition, current public health messaging and clinical HIV counselling in South Africa do not emphasize the prevention benefits of ART.
In this formative research study the investigators will develop an app-based educational video intervention that will provide information on Undetectable = Untransmittable (U=U) that is locally-appropriate and can be integrated into routine HIV counselling. The intervention will be piloted in a clinical trial of patients in South Africa receiving HIV post-test and adherence counselling services, to determine feasibility and acceptability, impact on U=U knowledge and attitudes, impact on stigma and psychological well being, and preliminary evidence for ART uptake and adherence.
The study builds on a longstanding collaboration between Boston University and the Health Economics and Epidemiology Research Office (HE2RO) at the University of Witwatersrand in Johannesburg, South Africa. The study is highly innovative because the investigators take a novel approach - disseminating information on the prevention benefits of ART - to improve the wellbeing of people living with HIV (PLWH) and motivate early uptake of ART in South Africa.
The investigators hypothesize that disseminating treatment-as-prevention on its merits could substantially improve the wellbeing of PLWH and increase demand for ART, enabling countries to maximize the impact of test-and-treat.
Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement
Study Type: Interventional
Start Date: November 15, 2022
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): The Regents of the Univ. of Calif., U.C. San Diego, La Jolla, California, United States
A two-arm RCT will be conducted to test the efficacy of Women SHINE, a web-based trauma-informed peer navigation-social support intervention (Figure 2). A total of 360 women living with HIV/AIDS (WLHA) with a history of adulthood interpersonal violence who have been prescribed ART but are non-adherent (< 90% ART adherent in the last 4 weeks) will be enrolled in the study. WLHA will be randomized (1:1) into one of the following conditions: 1) Women SHINE intervention arm (n=180) or 2) Control arm (n=180). The Women SHINE intervention arm will receive a four-month intervention including peer navigator (PN) one-on-one sessions, phone/text-based check-ins, 7 psychoeducation weekly support group sessions (120 mins.) co-facilitated by a licensed therapist and PN, and access to a static website with resources for HIV care, interpersonal violence, trauma, mental health, and substance use. The control arm will receive one group session (60 mins.) on self-care and well-being and access to the aforementioned website with resources. Women will complete a video-based survey and mailed hair sample self-collection at baseline, 4-, 8-, and 12-months post-randomization, to evaluate improvements in ART adherence (Aim 1), emotion regulation, and PTSD symptoms (Aim 2). Investigators will examine the mediating effect of individual (retention in HIV care, coping self-efficacy, social support, ancillary support services use) and socio-structural (stigma, medical mistrust) mechanisms of change on the efficacy of Women SHINE (Aim 3).
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
Study Type: Interventional
Start Date: October 5, 2022
Eligibility: Age N/A, Does Not Accept Healthy Volunteers
Location(s): Rush University, Cook County Hospital NICHD CRS, Chicago, Illinois, United States
This study will test an anti-HIV drug (ARV) for newborn babies. The study will include a minimum of 36 and up to 108 mothers living with HIV and their newborn babies from Brazil, South Africa, Thailand, and the United States. Infants will be in the study for approximately 16 weeks (four months) after they are born. Mothers will not receive study drug and will exit the study after the Entry visit.
Clinic-based HIV Identification and Prevention Project Using Electronic Resources
Study Type: Interventional
Start Date: October 3, 2022
Eligibility: Females, 15 Years to 65 Years, Accepts Healthy Volunteers
Location(s): Johns Hopkins Health System, Baltimore, Maryland, United States
Hybrid Type II effectiveness-implementation trial to investigate whether electronic medical and sexual history data collection with HIV risk categorization/scoring will increase pre-exposure prophylaxis (PrEP) uptake among cis-gender women attending routine well-woman gynecologic preventative visits.
Le Kip Kip: A Campaign to Change Social Norms and Build Sustainable Demand for PrEP Among Women in South Africa
Study Type: Interventional
Start Date: October 1, 2022
Eligibility: Females, 15 Years and Older, Does Not Accept Healthy Volunteers
Location(s): TB HIV Care, Cape Town, Western Cape, South Africa
The purpose of this study is to evaluate the impact of a social media campaign and community engagement activities to promote pre-exposure prophylaxis (PrEP) use among young women and to influence community norms around PrEP in South Africa. To do this, the investigative team will analyze PrEP initiation and retention data from the study's implementing partner, TB HIV Care, a non-profit organization providing PrEP to marginalized young women in South Africa. The effect of the social media campaign and community engagement will be tested using a short duration cluster randomized trial (CRT).
SYV: A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth
Study Type: Interventional
Start Date: September 7, 2022
Eligibility: 10 Years to 24 Years, Does Not Accept Healthy Volunteers
Location(s): Baylor College of Medicine Children's Foundation - Tanzania, Mbeya Centre for Excellence, Mbeya, Tanzania; Mawenzi Regional Referral Hospital, Moshi, Tanzania; Baylor College of Medicine Children's Foundation - Tanzania, Mwanza Centre for Excellence, Mwanza, Tanzania; Bugando Medical Centre, Mwanza, Tanzania; Chronic Disease Clinic of Ifakara Health Institute, Ifakara, Tanzania; Kilimanjaro Christian Medical Centre, Moshi, Tanzania
The overall objectives of this proposal are to support positive coping strategies that bolster mental health and lead to improved HIV outcomes among Young People Living with HIV (YPLWH). The central hypothesis is that SYV (Sauti ya Vijana, The Voice of Youth) will be effective to improve antiretroviral therapy (ART) adherence and virologic suppression in YPLWH in Tanzania. The rationale for this project is that by targeting mental health, which is strongly associated with medication adherence, that this will effectively improve adherence and thereby HIV viral suppression. The central hypothesis will be tested in three aims in a hybrid type-1 effectiveness-implementation trial.
Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
Study Type: Interventional
Start Date: August 30, 2022
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of Miami, Miami, Florida, United States
The purpose of this randomized controlled trial is to understand how a cognitive-behavioral treatment (a form of psychological treatment) for depression changes the gut microbiome (micro-organisms that regulate the health of the gut), immune system, and the brain functioning in people living with HIV.
AmbassADDOrs for Health Study
Study Type: Interventional
Start Date: July 26, 2022
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): Mwanza Province, Mwanza, Tanzania
The goal of the study is to evaluate Malkia Klabu ("Queen Club") in Tanzania, a loyalty program intervention that creates adolescent girls and young women (AGYW)-friendly drug shops where AGYW can access HIV prevention services and contraception.
Rudi Kundini, Pamoja Kundini: Phase I
Study Type: Interventional
Start Date: July 25, 2022
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Kagera Region, Kagera, Tanzania; Geita Region, Geita, Tanzania
This protocol describes a 2-arm cluster, randomized controlled trial designed to test the effectiveness of a conditional cash transfer on viral suppression at 6 months among people living with HIV infection (PLHIV) in Tanzania who have disengaged from HIV care. Randomization will take place at the clinic level (HIV primary care clinics). The comparison group receives standard of care standard of care HIV tracing services according to Tanzania's National Guidelines for the Management of HIV and the Ministry of Health to locate potential participants, including home based care (HBC) tracing of PLHIV who have disengaged from primary care, the provision of counseling to return to HIV care, and the offer to schedule an HIV primary care appointment on the spot. Eligible adult PLHIV disengaged from HIV care and living in an intervention facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time cash transfer incentive, conditional upon confirmed completion of a clinical visit if within 90 days of study enrollment. The primary endpoint is viral suppression (<1000 copies/ml) at 6 months after study enrollment.
Traditional Healer-initiated HIV Counseling and Testing in South Africa
Study Type: Interventional
Start Date: July 22, 2022
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): Thulamahashe Health Facility, Thulamahashi, Mpumalanga, South Africa
The objective of this proposal is to conduct a pilot test of a program aimed at training traditional healers to conduct HIV testing and implementing HIV testing among people living in Bushbuckridge, South Africa.
Pilot Healer-initiated HIV testing uptake and linkage to prevention services. Trust in allopathic health care and HIV stigma will be measured among participants at study enrollment and at month seven.
Hypothesis: Healer-initiated HIV counseling and testing (HICT) will increase trust in allopathic health care and reduce HIV stigma.
Microeconomic Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women
Study Type: Interventional
Start Date: July 20, 2022
Eligibility: Females, 18 Years to 45 Years, Accepts Healthy Volunteers
Location(s): Virginia Commonwealth University, Richmond, Virginia, United States
The purpose of this research study is to learn more about the economic situations, discrimination experiences, and risk behaviors of transgender women. The ultimate purpose of the study is to test an intervention to improve financial conditions and reduce HIV risk behaviors in transgender women.
CPT-L to Improve Outcomes for Individuals With HIV and PTSD
Study Type: Interventional
Start Date: July 13, 2022
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Medical University of South Carolina, Charleston, South Carolina, United States
This study plans to adapt and examine the acceptability and feasibility of an evidence-based PTSD treatment that has reduced other HIV transmission behavior (e.g., sexual risk), Cognitive Processing Therapy (CPT), at an HIV clinic as a strategy to improve HIV outcomes in this population.
Clinical Decision Support for PrEP
Study Type: Interventional
Start Date: July 11, 2022
Eligibility: 15 Years and Older, Accepts Healthy Volunteers
Location(s): Roanoke Chowan Community Health Center, Ahoskie, North Carolina, United States; Saban Community Clinic, Los Angeles, California, United States; Kintegra Health, Gastonia, North Carolina, United States
Scale-up of HIV preexposure prophylaxis (PrEP) is a key strategy of the federal initiative to end the HIV epidemic. However, healthcare providers lack tools to identify patients who are at increased risk for HIV infection and thus likely to benefit from PrEP. This pilot study will test the hypothesis that an electronic health record (EHR)-based clinical decision support system that incorporates an HIV risk prediction model can help providers identify patients at increased risk for HIV infection and improve PrEP prescribing in safety-net community health centers. The clinical decision support system will be implemented in the EHR at 2-3intervention clinics, while 2 control clinics will receive standard of care. The primary outcome is PrEP prescriptions. Other key metrics of PrEP-related care to be assessed include medication persistence, adherence to monitoring guidelines for PrEP, and rates of HIV/STI testing and diagnoses. The expected outcome is the foundation for a large-scale cluster randomized trial to test whether EHR-based clinical decision support tools for PrEP can improve PrEP prescribing and prevent new HIV infections in a national network of community health centers.
Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV
Study Type: Interventional
Start Date: June 21, 2022
Eligibility: 15 Years to 21 Years, Does Not Accept Healthy Volunteers
Location(s): University of Cape Town, Cape Town, South Africa
The overall goal of this pilot randomized-controlled trial (RCT) is to pilot MASI (MAsakhane Siphucule Impilo Yethu; Xhosa for "Let's empower each other and improve our health"), an ART adherence-supporting smartphone app with 50 adolescents and young adults living with HIV to assess its feasibility and acceptability and to explore preliminary effects on ART adherence and social support.
Community Health Worker Training to Reduce Depression and Substance Use Stigma in TB/HIV Care in South Africa
Study Type: Interventional
Start Date: June 8, 2022
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): South African Medical Research Council, Cape Town, Western Cape, South Africa
Poor engagement in care contributes to HIV- and TB-related morbidity and mortality in South Africa (SA). Community health workers (CHWs) are frontline lay health workers who work to re-engage patients who are lost to follow-up (LTFU) in HIV/TB care. Patients with depression and substance use (SU) have a greater likelihood of being LTFU in HIV/TB care, and there is evidence that CHWs may exhibit stigma towards these patients. When CHWs have negative attitudes towards these patients, on average they spend less time with these patients, are less likely to implement evidence-based practices, and deliver less patient-centered care. Therefore, this purpose of this study is to examine the implementation and preliminary effectiveness of a brief training ("Siyakhana"). The purpose of this training is to provide CHWs with psychoeducation, skills, and support around working with HIV/TB patients with depression/SU. The investigators will assess the training's implementation and changes in CHWs' stigma towards HIV/TB patients with depression/SU.
Peer Led Outreach to Engage Male Partners of Pregnant Women in Uganda (Okutuuka Study)
Study Type: Interventional
Start Date: May 20, 2022
Eligibility: 14 Years and Older, Accepts Healthy Volunteers
Location(s): Infectious Disease Institute, Kampala, Uganda
It is critical to evaluate strategies that leverage women's engagement in antenatal care to increase male partner testing while alleviating the burden on pregnant women to encourage their male partners to HIV test. A peer-delivered status-neutral approach to male partners of pregnant women may be an innovative strategy to overcome barriers to men's reluctance to test for HIV and initiate HIV prevention or treatment services. For pregnant women living with HIV, partner testing and disclosure could facilitate women's continuation of ART post-partum, and for HIV-negative women at risk of HIV acquisition, this could facilitate women's initiation of PrEP during pregnancy. Thus, multiple public health goals could be achieved through increasing the proportion of men who know their HIV status.
Pharmacy-based Pre-exposure Prophylaxis
Study Type: Interventional
Start Date: May 19, 2022
Eligibility: Males, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Emory University, Atlanta, Georgia, United States
The proposed research will develop a culturally appropriate pharmacy PrEP delivery model for black men who have sex with men (BMSM) who live in high poverty, racial minority neighborhoods. Increasing access to PrEP through pharmacies has the potential to increase PrEP uptake among BMSM thereby reducing HIV incidence and racial inequities in HIV.
Addressing Intimate Partner Violence, Mental Health, and HIV in Antenatal Care
Study Type: Interventional
Start Date: April 26, 2022
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Malvern Clinic, Johannesburg, Gauteng, South Africa
This quasi-experimental feasibility study recruit n=40 participants from each of two public antenatal clinics in Johannesburg, South Africa. Using the Bowen et al. approach, key feasibility study questions will be those around acceptability, implementation, and promising effects on intermediate variable. While this pilot trial is not powered to determine efficacy, it can help establish whether intervention targets the appropriate intermediate mechanisms (i.e. primary endpoints of IPV exposure and depressive symptoms) and moves intended outcomes in the right direction (i.e. towards better adherence as measured by self-reported adherence).
Development of a Telehealth-delivered Peer Navigation and Coping Skills Intervention to Increase PrEP Use in Young Black MSM
Study Type: Observational
Start Date: April 1, 2022
Eligibility: Males, 15 Years to 24 Years
Location(s): Massachusetts General Hospital, Boston, Massachusetts, United States
The goal of this observational study is to obtain qualitative knowledge on experiences of YBMSM ages 15-24 and specify role of peer navigator in promoting use of pre-exposure prophylaxis (PrEP). Participants at various stages of the PrEP continuum (e.g., never used, former user, and currently using PrEP) will complete in-depth interviews. Interviews will explore how contextual factors and self-change processes influence PrEP use.
The knowledge gained from these interviews will be used to inform intervention development in Aim 2.
M-Suubi: A Multi-Level Integrated Intervention to Reduce the Impact of HIV Stigma
Study Type: Interventional
Start Date: March 15, 2022
Eligibility: 10 Years to 17 Years, Accepts Healthy Volunteers
Location(s): International Center for Child Health and Development Field Office, Masaka, Uganda
M-Suubi, a three arm cluster randomized study will examine the effects and cost-effectiveness of a multi-level intervention on HIV viral suppression among 840 adolescents living with HIV (ALHIV) enrolled in 42 secondary schools with a boarding section. The investigators will test the effects of a group-based HIV stigma reduction intervention for educators (GED-HIVSR), over and above the effects of multiple family groups with HIV stigma reduction combined with family economic empowerment (MFG-HIVSR plus FEE), relative to Bolstered Standard of Care (BSOC). ALHIV will be randomized at the school level to one of three study arms
Supporting Sustained HIV Treatment Adherence After Initiation
Study Type: Interventional
Start Date: March 9, 2022
Eligibility: 16 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Mzamomhle, Cape Town, Western Cape, South Africa; Weltevreden Valley, Cape Town, Western Cape, South Africa; Phumlani, Cape Town, Western Cape, South Africa
The investigators will implement a 24-month fractional factorial design study (Aim 1). The investigators will recruit 510 patients initiating antiretroviral therapy (ART) at three City of Cape Town ART clinics. Each patient will have adherence monitored using the Wisepill® electronic adherence monitoring device (EAM). After eligibility has been confirmed, each participant will be randomized to one of 16 experimental conditions. Each condition includes a unique combination of five adherence intervention components. Three of these components focus on identifying individuals with poor adherence, with increasing degrees of sophistication, with immediate linkage to adherence support. Two components focus on supporting good adherence. They both supplement the existing adherence support program delivered at the study clinics operated by City of Cape Town (standard of care component). Based on Self-Determination Theory, the investigators postulate these intervention components will: 1) enhance feelings of autonomy support, social support, and knowledge; 2) improve motivation and self-competence; and 3) increase ART retention, adherence, and viral suppression. A subset of the participants, as well as clinic staff, will be invited to in-depth interviews to explore mediating factors (Aim 1) and the implementation process (Aim 2); and the data collected in Aims 1 and 2 will be used to explore cost effectiveness (Aim 3).
TAKE Steps: Motivational Interviewing to Prevent STIs
Study Type: Interventional
Start Date: March 8, 2022
Eligibility: 13 Years to 19 Years, Does Not Accept Healthy Volunteers
Location(s): CHOP Primary Care, Cobbs Creek, Philadelphia, Pennsylvania, United States; CHOP Primary Care, South Philadelphia, Philadelphia, Pennsylvania, United States; Primary Care, CHOP Clinic 3550 Market St, Philadelphia, Pennsylvania, United States; CHOP Primary Care, Roxborough, Philadelphia, Pennsylvania, United States; CHOP Karabots Pediatric Care Center, West Philadelphia, Philadelphia, Pennsylvania, United States
This study will consist of a randomized controlled trial of a motivational interviewing intervention for adolescents with diagnosed sexually transmitted infections (STIs). The sessions will provide HIV/STI prevention education, use motivational interviewing (MI) to enhance goal setting, and providing skill building and referral to evidence based STI and HIV prevention strategies Pre-Exposure Prophylaxis (PrEP), condom use, and partner notification.
Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya
Study Type: Interventional
Start Date: February 24, 2022
Eligibility: Females, 16 Years to 24 Years, Accepts Healthy Volunteers
Location(s): Partners in Health and Research Development, Thika, Kenya
Few young women at risk of HIV infection are initiating pre-exposure prophylaxis (PrEP) for HIV prevention in Kenya, thus we propose refining and testing a new model to increase PrEP initiation among young women at high HIV risk that has never been explored: peer PrEP referral + HIV self-test (HIVST) delivery. We conducted formative research to design of a model that is acceptable to young women and feasible to implement in Kenya. In this study, we will refine this model where young (≥16 to 24 years) female PrEP users refer their peers to PrEP and deliver HIVSTs in a pilot study and then test the refined model in a hybrid effectiveness-implementation trial. We hypothesize that relative to informal word-of-month peer PrEP referral (currently ongoing in Kenya), formalized peer PrEP referral + HIVST delivery will increase PrEP adoption (i.e., initiation, retention, and adherence) among peers, and be low cost and have high fidelity in Kenya.
Developing mHealth to Promote PrEP Use Among Thai Young Men Who Have Sex With Men
Study Type: Interventional
Start Date: February 23, 2022
Eligibility: Males, 16 Years to 25 Years, Accepts Healthy Volunteers
Location(s): Institute of HIV Research and Innovation, Bangkok, Thailand; Rainbow Sky Association of Thailand, Bangkok, Thailand
The goal of this study is to develop and pilot test technology-based interventions to promote Pre-exposure Prophylaxis (PrEP) uptake and adherence among Thai young men who have sex with men (YMSM).
Mobile HIV Prevention App for Black Women
Study Type: Interventional
Start Date: February 5, 2022
Eligibility: Females, 18 Years to 44 Years, Accepts Healthy Volunteers
Location(s): Center for Black Women's Wellness, Atlanta, Georgia, United States
Black women have a significantly higher risk of acquiring HIV compared to their non-Black counterparts.
The purpose of this study is to refine and test a mobile HIV Prevention and Reproductive Health app developed specifically for Black women.
Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV
Study Type: Observational
Start Date: February 2, 2022
Eligibility: Age N/A, Does Not Accept Healthy Volunteers
Location(s): Johns Hopkins University NICHD CRS (5092), Baltimore, Maryland, United States; Univ of Miami Pediatric/Perinatal HIV/AIDS (5127), Miami, Florida, United States; 5055, South Florida CDTC Fort Lauderdale Clinical Research Site, Fort Lauderdale, Florida, United States; University California, San Diego (CRS 4601), San Diego, California, United States; David Geffen School of Medicine at UCLA (CRS 5112), Los Angeles, California, United States; Siriraj Hospital Mahidol University CRS (5115), Bangkok, Ratchathewi, Thailand; Family Clinical Research Unit (FAM-CRU) CRS (8950), Tygerberg Hills, South Africa; 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center Kericho Clinical Research Site, Kericho, Kenya; School of Medicine, University of Minas Gerais - FUNDEP (5073), Belo Horizonte, Brazil; 5128, Texas Children's Hospital Clinical Research Site, Houston, Texas, United States
IMPAACT 2028 is an observational prospective study to characterize a cohort of early treated children who may participate in future research related to HIV remission or cure. Up to approximately 250 participants will be in the study for approximately seven years. No intervention is provided in the study.
Developing a Trauma-focused Intervention for Older Adults Living With HIV
Study Type: Interventional
Start Date: January 18, 2022
Eligibility: 50 Years to 85 Years, Does Not Accept Healthy Volunteers
Location(s): University of South Carolina, Columbia, South Carolina, United States
Investigators are adapting the LIFT and REFLECT interventions for older adults living with HIV who have been exposed to childhood sexual abuse.
Peer-driven Intervention on PrEP
Study Type: Interventional
Start Date: January 6, 2022
Eligibility: Males, 18 Years and Older, Accepts Healthy Volunteers
Location(s): The Miriam Hospital, Providence, Rhode Island, United States
The objective of this study is to develop an effective peer-driven intervention (PDI) approach and assess its feasibility and efficacy on pre-exposure prophylaxis (PrEP) uptake among men who have sex with men.
Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya
Study Type: Interventional
Start Date: January 1, 2022
Eligibility: Females, 15 Years to 100 Years, Accepts Healthy Volunteers
Location(s): Ober Health Center, Homa Bay, Kenya
This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.
HIV-related Insomnia and Inflammation
Study Type: Interventional
Start Date: December 2, 2021
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Indiana University Infectious Diseases Research, Indianapolis, Indiana, United States
This randomized trial will determine the effects of internet cognitive behavioral therapy on measures of systemic inflammation in HIV-positive people receiving antiretroviral therapy.
Parrying the Pitfalls of PrEP: Project PEACH
Study Type: Interventional
Start Date: November 20, 2021
Eligibility: Males, 18 Years to 45 Years, Does Not Accept Healthy Volunteers
Location(s): PRISM Research Center, Atlanta, Georgia, United States
The study is a prospective cohort of young MSM who are followed for 2 years either in-person at the PRISM Health Research Clinic and/or virtually with telehealth study visits. Follow-up visits occur as frequently as every 3 months, or as appropriate to clinical needs of HIV PrEP or STI PEP. The investigators will enroll men who may decide to start or stop PrEP, change from daily oral PrEP to on-demand oral PrEP or from on-demand oral PrEP to daily PrEP, to start or stop STI PEP at any point in the study period, or injectable PrEP as an alternative to daily oral PrEP or on-demand oral PrEP. All men will be provided with the study's mobile smart phone app to support early identification of risks for PrEP discontinuation, to provide information about STI PEP and document usage patterns of on-demand oral PrEP and STI PEP, and to support easy linkage to support services for PrEP counseling and addressing concerns or questions about STI PEP and injectable PrEP.
Effectiveness of Transdiagnostic Cognitive Behavioral Therapy for Improving HIV Treatment Outcomes in South Africa
Study Type: Interventional
Start Date: November 12, 2021
Eligibility: Females, 18 Years and Older, Accepts Healthy Volunteers
Location(s): HIV Clinic, Johannesburg, Gauteng, South Africa
This study will evaluate the impact of the Common Elements Treatment Approach (CETA), an evidence-based intervention comprised of cognitive-behavioral therapy elements, at improving HIV treatment outcomes among women with HIV who have experienced intimate partner violence (IPV) and have an unsuppressed viral load on HIV treatment. To evaluate CETA, the investigators will conduct a randomized controlled trial of HIV-infected women, with or without their partners, who have experienced IPV and have an unsuppressed viral load to test the effect of CETA in increasing viral suppression and reducing violence. The investigators will also identify mediators and moderators of CETA's effect on retention and viral suppression and assess the cost and cost-effectiveness of CETA vs. active control at increasing the proportion who are retained and virally suppressed by 12 months.
The SMART ART Study
Study Type: Interventional
Start Date: November 2, 2021
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Human Sciences Research Council Sweetwaters, Sweetwaters, Kwa-zulu Natal, South Africa
The investigators propose A Sequential Multiple Assignment Randomized Trial of scalable interventions for ART delivery in South Africa- the SMART ART study-a randomized study to test adaptive ART delivery for persons with detectable viral load and/or not engaged in care.The types of differentiated service delivery (DSD) that will be examined in this study are incentives, community-based ART, and home delivery. The study plans to enroll up to 900 participants-people living with HIV and who are eligible for ART and living in KwaZulu-Natal, South Africa. The study aims to maximize the proportion of ART eligible persons living with HIV who achieve viral suppression at 18 months. The study will also evaluate the preferences of clients and providers for differentiated service delivery, and evaluate the cost effectiveness of adaptive HIV treatment for those who are not engaged in care.
Package of Resources for Assisted Contact Tracing: Implementation, Costs, and Effectiveness
Study Type: Interventional
Start Date: November 1, 2021
Eligibility: 15 Years and Older, Accepts Healthy Volunteers
Location(s): Chiendausiku Health Centre, Balaka, Malawi; Balaka OPD Health Centre, Balaka, Malawi; Balaka District Hospital, Balaka, Malawi; Nyambi Health Centre, Machinga, Malawi; Nthorowa Health Centre, Machinga, Malawi; Ntaja Health Centre, Machinga, Malawi; Nsanama Health Centre, Machinga, Malawi; Ngokwe health Centre, Machinga, Malawi; Nayuchi Health Centre, Machinga, Malawi; Nayinunje Health Centre, Machinga, Malawi; Namanja Health Centre, Machinga, Malawi; Namandanje Health Centre, Machinga, Malawi; Mposa Health Centre, Machinga, Malawi; Mpiri Health Centre, Machinga, Malawi; Mkwepere Health Centre, Machinga, Malawi; Mbonechela Dispensary, Machinga, Malawi; Mangamba Health Centre, Machinga, Malawi; Mahinga Health Centre, Machinga, Malawi; Machinga District Hospital, Machinga, Malawi; Kawinga Dispensary, Machinga, Malawi; Gawanani Health Centre, Machinga, Malawi; Chikweo Health Centre, Machinga, Malawi; Chamba Dispensary, Machinga, Malawi; Utale Health Centres, Balaka, Malawi; Ulongwe Health Centre, Balaka, Malawi; Phimbi Health Centre, Balaka, Malawi; Phalula Health Centre, Balaka, Malawi; Namdumbo Health Centre, Balaka, Malawi; Namanolo Health Centre, Balaka, Malawi; Mbera Health Centre, Balaka, Malawi; Kwitanda Health Centre, Balaka, Malawi; Kankao Health Centre, Balaka, Malawi; Kalembo Health Centre, Balaka, Malawi
Having health workers assist HIV-infected persons with the recruitment and testing of their sexual contacts and biological children is an effective and efficient way of identifying additional HIV-infected persons in need of HIV treatment and HIV-uninfected persons in need of HIV prevention. However, in Malawi, a country with a generalized HIV epidemic, health workers lack the counseling and coordination skills to routinely assist their HIV-infected clients with these services. This study will determine how to help health workers to effectively and efficiently provide these services to their patients through a set of digital capacity-building tools.
LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care
Study Type: Interventional
Start Date: September 14, 2021
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): UCSD AntiViral Research Center, San Diego, California, United States
Investigators will develop and pilot test a culturally tailored, trauma-informed smartphone app, called LinkPositively, for Black WLHA affected by interpersonal violence. Core components of LinkPositively include: a) Virtual Peer Navigation that includes phone and text check-ins and 4 weekly one-on-one video sessions to build skills to cope with barriers and navigate care; b) Social Networking platform to receive peer support; c) Educational and Self-care database with healthy living and self-care tips; d) GPS-enabled Resource Locator for HIV care and ancillary support service agencies; and e) ART self-monitoring and reminder system. The study will be conducted in 2 phases with corresponding aims. In Phase 1 (Aim 1), 4 focus groups with Black WLHA with experiences of interpersonal violence, one focus group with peer navigators, and 4-6 key informant interviews with providers will be conducted to determine which app features, content, and functions are most likely to support downloading, initiating use, and sustaining engagement over time. Aim 1 will culminate in usability testing by Black WLHA affected by interpersonal violence (n=8), to finalize intervention components and procedures. In Phase 2 (Aim 2), investigators will pilot test LinkPositively to assess feasibility and acceptability and determine preliminary effects of the intervention on HIV care outcomes (i.e., retention in care, ART adherence, viral suppression) and mechanism of change variables (i.e., social support, self-efficacy). Through a randomized control trial (RCT), participants will be randomly assigned to either the intervention arm (n=40) or control arm (Ryan White standard of care, n=40), with follow-up at 3- and 6- months. This study will benefit the advancement of HIV prevention science by harnessing technology to promote engagement in HIV care, while improving social support through peers and social networking-all under the auspices of being trauma-informed for Black WLHA with experiences of interpersonal violence.
Engaging Men Through HIV Self-Testing With Differentiated Care to Improve ART Initiation and Viral Suppression Among Men in Malawi
Study Type: Interventional
Start Date: August 2, 2021
Eligibility: 15 Years and Older, Accepts Healthy Volunteers
Location(s): Partners in Hope, Lilongwe, Malawi
Men in sub-Saharan Africa who test HIV-positive continue to have poor ART initiation and retention outcomes. The proposed project will test a home-based ART intervention for men who are living with HIV compared to facility-based ART. Findings will provide essential information on how to best reach men across the testing and treatment continuum, a critical step to curbing the HIV epidemic.
Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
Study Type: Observational
Start Date: June 8, 2021
Eligibility: Females, Age N/A, Does Not Accept Healthy Volunteers
Location(s): Hospital Federal dos Servidores do Estado NICHD CRS, Rio De Janeiro, Brazil; Siriraj Hospital, Mahidol University NICHD CRS, Bangkok, Bangkoknoi, Thailand; Wits RHI Shandukani Research, Johannesburg, Gauteng, South Africa; IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS, San Juan, Puerto Rico; Bronx-Lebanon Hospital Center NICHD CRS, Bronx, New York, United States; Rush University Cook County Hospital Chicago NICHD CRS, Chicago, Illinois, United States; Usc La Nichd Crs, Los Angeles, California, United States; University of Florida Jacksonville NICHD CRS, Jacksonville, Florida, United States; South Florida CDTC Ft Lauderdale NICHD CRS, Fort Lauderdale, Florida, United States
The purpose of this study is to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.
PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
Study Type: Interventional
Start Date: May 1, 2021
Eligibility: Females, Age N/A, Accepts Healthy Volunteers
Location(s): Nyahera Sub Sub County Hospital, Kisumu, Kenya; Bondo County Referral Hospital, Siaya, Kenya; Masogo Sub-County Hospital, Kisumu, Kenya; Ober Health Center, Homa Bay, Kenya; Kendu Sub-District Hospital, Homa Bay, Kenya; Uyawi Sub County Hospital, Siaya, Kenya; Malanga Health Center, Siaya, Kenya; Madiany Sub County Hospital, Siaya, Kenya
This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.
InTSHA: Interactive Transition Support for HIV-infected Adolescents Using Social Media
Study Type: Interventional
Start Date: April 15, 2021
Eligibility: 15 Years to 19 Years, Does Not Accept Healthy Volunteers
Location(s): University of Kwazulu-Natal, Westville, South Africa
The goal of this study is to develop and evaluate a social media behavioral intervention based on the Social-ecological Model of Adolescent and Young Adult Readiness to Transition (SMART) to improve transition care for adolescents living with HIV in South Africa. Participants will be randomized to receive the social media intervention or the standard of care.
A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
Study Type: Interventional
Start Date: April 15, 2021
Eligibility: 15 Years and Older, Accepts Healthy Volunteers
Location(s): IDRC Southwest Uganda, Mbarara, Uganda; GPRT / SEARCH Office, Kisumu, Kenya
The randomized trials in this record will assess effectiveness, fidelity and cost of prevention and treatment interventions for HIV and hypertension with the objective of informing a population-based study of multi-sectored, multi-disease interventions for HIV.
PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya
Study Type: Interventional
Start Date: March 1, 2021
Eligibility: Females, Age N/A, Accepts Healthy Volunteers
Location(s): Kenyatta National Hospital, Kisumu, Kenya
This a prospective, open-label implementation project to catalyze integration of HIV prevention and PrEP care services for adolescent girls and young women in family planning clinics in Kenya.
A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa
Study Type: Interventional
Start Date: February 18, 2021
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of Cape Town, Cape Town, South Africa
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. We propose a full-scale randomized controlled trial to examine the effect of ImpACT+ on clinical outcomes in the period after ART initiation and to understand mental health and behavioral mechanisms through which viral suppression can be achieved. ImpACT+ will target women who are initiating ART in order to take advantage of a window of opportunity in HIV care and maximize care engagement. The aims are to test the effectiveness of ImpACT+ and explore its potential for implementation.
Neuroinflammation and Modulating Factors in Depression and HIV
Study Type: Interventional
Start Date: February 1, 2021
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): Infectious Diseases Institute, Kampala, Uganda
Determine if depression, which persists after depression treatment at 26 weeks, is associated with increased innate inflammation in a prospective cohort of HIV-infected Ugandans receiving SSRIs in which group psychotherapy is initiated.
Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients
Study Type: Interventional
Start Date: December 21, 2020
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Brown University, Providence, Rhode Island, United States
The overall aim of this program of research is to test a newly developed intervention, Acceptance-Based Behavior Therapy (ABBT), to improve HIV patients' commitment to medical care.
The purpose of the proposed project is to establish the efficacy of ABBT and examine its mechanisms of action. To achieve the specific aims, the investigators will conduct a randomized clinical trial (n = 270), with two treatment arms: ABBT vs. an attention-matched HIV education control condition.
Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP
Study Type: Interventional
Start Date: December 1, 2020
Eligibility: Males, 18 Years and Older, Accepts Healthy Volunteers
Location(s): CRT - Centro de Referência e Treinamento DST/AIDS, São Paulo, Brazil; SAE - Serviço de Assistência Especializada Campos Elíseos, São Paulo, Brazil
This is a randomized controlled trial of a multi-level intervention to prevent HIV acquisition among transgender women (N=400) in São Paulo, Brazil. The intervention will be evaluated using a randomized wait-list controlled trial to compare uptake of HIV testing (self-testing and clinic-based) (Aim 1), PrEP initiation and persistence (Aim 2), and other prevention services (e.g. harm reduction) among trans women in the intervention arm compared to those in the control arm with data collection scheduled every three-months. Investigators will assess changes in intersectional stigma (Aim 3), including reductions in internalized stigma and increased resilience to anticipated and enacted stigma, among those assigned to intervention compared to those assigned to the control arm, and assess how changes in stigma result in prevention uptake.
Harambee: Integrated Community-based HIV/NCD Care & Microfinance Groups in Kenya
Study Type: Interventional
Start Date: November 26, 2020
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Moi University/ Moi Teaching and Referral Hospital, Eldoret, Kenya
The objective of this project is to demonstrate the effectiveness and longer-term sustainability of a differentiated care delivery model for improving HIV treatment outcomes. The central hypothesis is that the integration of community-based HIV and NCD care with group microfinance will improve retention in care and rates of viral suppression (VS) among people living with HIV (PLHIV) in Kenya via two mechanisms: improved household economic status and easier access to care.
The specific aims are as follows:
To evaluate the extent to which integrated community-based HIV care with group microfinance affects retention in care and VS among n=900 PLHIV in rural western Kenya using a cluster randomized intervention design of n=40 existing (fully HIV+) microfinance groups to receive either: (A) integrated community-based HIV and NCD care or (B) standard care. Data from the two trial arms will be augmented with a matched contemporaneous control group of n=300 patients receiving standard care and not involved in microfinance (group C), comparing outcomes in groups A, B and C. The hypothesize is that A > B > C in terms of viral suppression and retention in care. To identify specific mechanisms through which microfinance and integrated community-based care impact VS. Using a mixed methods approach, the study will characterize the mechanisms of effect on patient outcomes. Investigators will conduct quantitative mediation analysis to examine two main mediating pathways (household economic conditions and easier access to care), as well as exploratory mechanisms (food security, social support, HIV- related stigma). Investigators will also use qualitative methods and multi-stakeholder panels to contextualize implementation of the intervention. To assess the cost-effectiveness of microfinance and integrated community-based care delivery to maximize future policy and practice relevance of this promising intervention strategy. The working hypothesis is that the differentiated model will be cost-effective in terms of cost per HIV suppressed person-time, cost per patient retained in care, and cost per disability-adjusted life year saved.
The main expected outcomes will be rigorous evidence of effectiveness, mechanisms and cost-effectiveness of a differentiated model for achieving the last key step in the HIV care continuum. These results are expected to have an important positive impact in terms of improved, high-quality services that address known individual and structural barriers to care and promote long-term sustainability of care for PLHIV in rural settings with high HIV prevalence.
Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya
Study Type: Interventional
Start Date: October 5, 2020
Eligibility: Females, Age N/A, Does Not Accept Healthy Volunteers
Location(s): Likoni Subcounty Hospital, Likoni, Mombasa, Kenya; Malanga Subcounty Hospital, Malanga, Siaya, Kenya; Sigomere Health Center, Sigomere, Siaya, Kenya; Ukwala Subcounty Hospital, Ukwala, Siaya, Kenya; Yala Subcounty Hospital, Yala, Siaya, Kenya; Akala Subcounty Hospital, Siaya, Kenya; Siaya County Hospital, Siaya, Kenya; Mariakani Subcounty Hospital, Mariakani, Kilifi, Kenya; Mtwapa Subcounty Hospital, Mtwapa, Kilifi, Kenya; Vipingo Subcounty Hospital, Vipingo, Kilifi, Kenya; Ambira Subcounty Hospital, Ambira, Siaya, Kenya; Bondo Subcounty Hospital, Bondo, Siaya, Kenya
The goal of this project is to rigorously evaluate the efficacy of HIV Infant Tracking System 2.1 (HITSystem, an eHealth intervention that uses short message service (SMS) texts to patients and algorithm-driven electronic alerts for providers) to increase retention in guideline-adherent prevention of mother-to-child transmission of HIV services (PMTCT) and to increase viral suppression and appropriate clinical action through the extended period of 6 months postpartum, compared to standard of care PMTCT services in a matched, cluster randomized controlled trial.
Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care
Study Type: Interventional
Start Date: September 3, 2020
Eligibility: Males, 18 Years and Older, Accepts Healthy Volunteers
Location(s): Fenway Health, Boston, Massachusetts, United States; University of Miami, Miami, Florida, United States
The purpose of this study is to test how different types of interventions may affect how someone takes their pre-exposure prophylaxis (PrEP) medication.
HIV Treatment Adherence Dose Determination Trial
Study Type: Interventional
Start Date: September 1, 2020
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of Connecticut, Storrs, Connecticut, United States; University of Connecticut Field Site, Atlanta, Georgia, United States
The proposed research will conduct the first dose-determination trial to find the optimal number of behavioral counseling sessions (dose) needed to achieve and sustain optimal HIV treatment adherence. The results of this study will determine how much intervention is needed for whom and at what cost to guide health policy and implementation of behavioral interventions designed to improve durable viral suppression.
Biomedical HIV/AIDS Prevention Program Yunnan
Study Type: Interventional
Start Date: August 1, 2020
Eligibility: Males, 18 Years and Older, Accepts Healthy Volunteers
Location(s): Yunnan Center for Disease Prevention and Control, Kunming, Yunnan, China
B-HAPPY is an implementation project to study the process by which pre-exposure prophylaxis (PrEP) is introduced and integrated into a specific international health system facing high rates of HIV incidence among men who have sex with men. The study will use a stepped wedge design to compare implementation outcomes across eight municipalities in Yunnan, China.
Streamlining the Efficiency of PrEP Implementation
Study Type: Observational
Start Date: May 1, 2020
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Partners in Health Research and Development, Thika, Kenya
This is a pilot facility-based direct-to-pharmacy PrEP refill delivery to streamline care pathway in Kenyan public health HIV facilities implementing PrEP. Data on up to 500 PrEP users will be evaluated to understand delivery efficiency and in-depth interview with users and delivery key informants will be conducted to identify barriers and facilitators of implementation.
An Avatar-based Mobile Phone Intervention to Promote Health in African American MSM
Study Type: Interventional
Start Date: March 4, 2020
Eligibility: Males, 18 Years to 34 Years, Does Not Accept Healthy Volunteers
Location(s): University of Illinois at Chicago, Chicago, Illinois, United States
The investigators propose to determine the efficacy of "My Personal Health Guide," a theory-based innovative talking relational human Avatar mobile phone application to engage HIV-positive AAMSM in adherence and retention in care. Providing an empathetic talking Avatar source of HIV-related information, motivation, and behavioral skills that is as private and convenient as their own mobile phone might produce a high impact by overcoming barriers to HIV adherence and retention in care such as stigma and health literacy.
A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0)
Study Type: Interventional
Start Date: October 9, 2019
Eligibility: Males, 18 Years to 34 Years, Accepts Healthy Volunteers
Location(s): Northwestern University, Chicago, Illinois, United States
This study evaluates and compares two implementation strategies of an online HIV prevention intervention: Strategy 1 in which community-based organizations apply, and are selected, for funding to deliver Keep It Up! through current HIV testing programs; and Strategy 2 which is a "direct-to-consumer" model where centralized staff at Northwestern University recruit participants nationally through online advertising campaigns and manage engagement.
Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings
Study Type: Interventional
Start Date: July 12, 2019
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Marondera Provincial Hospital, Marondera, Mashonaland East, Zimbabwe
A hybrid effectiveness-efficacy trial to evaluate a stepped care task shifted intervention to treat depression and HIV medication nonadherence in low resource settings in rural Zimbabwe.
The PrEP (Pre-exposure Prophylaxis) SMART Study
Study Type: Interventional
Start Date: May 16, 2019
Eligibility: Females, 18 Years to 25 Years, Accepts Healthy Volunteers
Location(s): Wits Reproductive Health and HIV Institute, Johannesburg, South Africa
The PrEP SMART study is testing a stepped model of scalable adherence support strategies in South African young women who initiate PrEP using a SMART (sequential multiple assignment randomized trial) design.
Pre-exposure Prophylaxis (PrEP) at Home
Study Type: Interventional
Start Date: April 26, 2019
Eligibility: Males, 18 Years to 49 Years, Accepts Healthy Volunteers
Location(s): Open Arms Health Care Center, Jackson, Mississippi, United States; The Fenway Institute, Boston, Massachusetts, United States; Emory University, PRISM Health, Atlanta, Georgia, United States; Washington University AIDS Clinical Trial Unit, Saint Louis, Missouri, United States; MetroHealth, Cleveland, Ohio, United States
This study is a randomized clinical trial of PrEP@Home, a home care system for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP). Individuals entering into PrEP care at an initial in-person study visit will be randomized to the PrEP@Home system for home-based PrEP care follow-up visits or to the control standard of care for clinic-based follow-up visits. The primary aim of this study is to assess protective levels of PrEP medication for the intervention arm compared to the control arm.
Effects of Glucocorticoids on Cognition in HIV-infected Women
Study Type: Interventional
Start Date: November 20, 2017
Eligibility: Females, 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
Despite treatment with antiretroviral therapy, women living with HIV continue to experience cognitive impairment. Psychological risk factors, including stress, impair cognition more in HIV-infected women than HIV-uninfected women. This study plans to examine a novel intervention for cognitive dysfunction that targets the mechanisms by which stress negatively affects cognitive functioning.
Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite
Study Type: Observational
Start Date: November 1, 2017
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Seattle Children's Hospital, Seattle, Washington, United States; David Geffen School of Medicine at UCLA, Los Angeles, California, United States; Emory University School of Medicine, Atlanta, Georgia, United States; Rush University Cook County Hospital Chicago, Chicago, Illinois, United States; Johns Hopkins University, Baltimore, Maryland, United States; Boston Medical Center, Boston, Massachusetts, United States; New York University School of Medicine, New York, New York, United States; SUNY Stony Brook, Stony Brook, New York, United States; University of Southern California, Los Angeles, California, United States
This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition to adulthood.
Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
Study Type: Observational
Start Date: April 30, 2014
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): San Juan Research Hospital, San Juan, Puerto Rico; St. Jude Children's Research Hospital, Memphis, Tennessee, United States; Baylor College of Medicine, Houston, Texas, United States; University of California San Diego, La Jolla, California, United States; University of Colorado Denver Health Sciences Center, Aurora, Colorado, United States; Children's Diagnostic and Treatment Center, Fort Lauderdale, Florida, United States; University of Miami, Miami, Florida, United States; Ann and Robert H. Lurie Children's Hospital, Chicago, Illinois, United States; Tulane University Health Sciences Center, New Orleans, Louisiana, United States; Children's Hospital Boston, Boston, Massachusetts, United States; Rutgers - New Jersey Medical School, Newark, New Jersey, United States; Bronx Lebanon Hospital Center, Bronx, New York, United States; Jacobi Medical Center, Bronx, New York, United States; St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection (YAPHIV) as they transition into adulthood. A group of uninfected young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.