Clinical trials: Pre-exposure Prophylaxis (PrEP) Adherence
Gender-Based Violence
Tu'Washindi na PrEP: Adolescent Girls in Kenya Taking Control of Their Health
This study is nested within the ongoing DREAMS (Determined, Resilient, Empowered, AIDS-free, and Safe) initiative in Siaya County, Kenya.
- Trial name
- NCT03938818
- Testing
- Tu'Washindi intervention, Control
- Where
- Kenya
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- RTI International
HIV-1-infection
Postpartum Pre-exposure Prophylaxis (PrEP) Study to Evaluate an Adherence Promotion Package for Postpartum Women on PrEP
The postpartum PrEP study (PPS) seeks to evaluate how best to improve adherence to PrEP in postpartum women and to evaluate how acceptable it is to offer HIV self tests for the participant and partner, and provide enhanced…
- Trial name
- PPS (NCT04897737)
- Testing
- HIVST and enhanced adherence biofeedback, Orasure/UrSure test
- Where
- South Africa
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Transgender Persons, Pre-Exposure Prophylaxis
The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community
The Stay Study is a multi-site, open-label HIV pre-exposure prophylaxis (PrEP) demonstration project for advancing PrEP delivery in the San Francisco Bay Area Transgender Community.
- Trial name
- NCT03120936
- Testing
- Emtricitabine / Tenofovir Disoproxil Oral Tablet, PrEP support
- Where
- 5 sites in United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
HIV Infections
A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-Risk Populations in Kenya, Africa
This study will evaluate the safety and acceptability of an intermittent and daily PrEP regimen using Tenofovir Disoproxil Fumarate plus Emtricitabine (FTC/TDF) in men and women at risk for HIV, and it will directly compare…
- Trial name
- NCT00971230
- Testing
- FTC/TDF
- Where
- 2 sites in Kenya
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
Adherence, Medication, Adolescent Behavior
Youth-focused Strategies to Promote Adherence to Pre-exposure Prophylaxis Among Youth At-risk for HIV in Thailand
A randomized controlled clinical trial looking at the effect of use of a mobile phone application in addition to standard care compared to standard care alone at a youth-friendly clinic in young men who have sex with men and…
- Conditions
- Adherence, Medication, Adolescent Behavior, HIV Prevention, Sexual Health
- Trial name
- YouthPrEP (NCT03778892)
- Testing
- 'Project Raincoat' Mobile Phone Application
- Where
- Thailand
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
Pregnancy, HIV-1-infection
Pre-Exposure Prophylaxis Dosing in Pregnancy to Optimize HIV Prevention (PREP-P)
This trial is a prospective, multi-center, randomized comparison study of 2 Pre-Exposure Prophylaxis (PrEP) pharmacokinetic (PK) dosing regimens from 1st trimester through 12 weeks following delivery (postpartum) to achieve study…
- Trial name
- NCT03834909
- Testing
- Standard dose Truvada®, Pregnancy-adjusted dose Truvada®
- Volunteers
- healthy volunteers welcome
- Sponsor
- Johns Hopkins University
HIV-I Infection
Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women
The investigators will conduct an observational cohort study in 1200 pregnant women who will be recruited at the first antenatal care (ANC) visit from the Gugulethu and one additional facility in the Klipfontein-Mitchell's Plain…
- Trial name
- PrEP-PP (NCT03902418)
- Testing
- emtricitabine/tenofovir
- Where
- South Africa
- Volunteers
- 1,195 people
- Sponsor
- University of California, Los Angeles
HIV Prevention, Pre-exposure Prophylaxis (PrEP)
A Study Evaluating An Integrated Pharmacy Digital Diary and Delivery Strategy to Increase PrEP Use Among MSM and TGW
The PrEP 3D randomized controlled trial (RCT) will study the effectiveness of the PrEP-3D app compared to standard of care for starting pre-exposure prophylaxis (PrEP), continuing PrEP, and adherence to PrEP.
- Conditions
- HIV Prevention, Pre-exposure Prophylaxis (PrEP), Risk Reduction, Adherence, Medication
- Trial name
- PrEP-3D RCT (NCT05474313)
- Testing
- PrEP-3D package, Standard of Care
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
HIV Prevention
Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM
The goal of this clinical trial is to learn if two interventions-C4 and C4+3MV-can improve PrEP adherence (taking medication to prevent HIV) among Black men who have sex with men (MSM).
- Trial name
- C4+3MV (NCT06661343)
- Testing
- C4 Program, C4 + 3MV Program
- Where
- 2 sites in United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Yale University
Pregnancy, HIV Infections
Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR
To evaluate adherence to a single dual-prevention pill (DPP) compared with a two-pill regimen (2PR) for pre-exposure prophylaxis (PrEP) and pregnancy prevention in women without HIV.
- Trial name
- NCT07288190
- Testing
- DPP, 2PR, Free Choice
- Where
- 3 sites in Eswatini, Uganda and 1 more
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
Patient Adherence, HIV Seronegativity
Randomized Controlled Trial of iTAB Plus Motivational Interviewing for PrEP Adherence in Transgender Individuals
CCTG 603 is an open-label, two-arm, randomized (1:1) clinical demonstration project to determine if brief Motivational Interviewing (MI-B) added to a text-message based adherence intervention (iTAB) improves adherence to PrEP…
- Trial name
- NCT03086200
- Testing
- brief Motivational Interviewing
- Where
- 5 sites in United States
- Volunteers
- 263 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
HIV Pre-exposure Prophylaxis, HIV Prevention and Care
MyPrEP Plus: Development and Pilot Testing of Novel Preexposure Prophylaxis Decision Support Tools for Transgender Women
The primary goal of this randomized controlled trial is to learn if a decision support tool called MyPrEP Plus can help transgender women make decisions about taking pre-exposure prophylaxis (PrEP) for HIV prevention.
- Conditions
- HIV Pre-exposure Prophylaxis, HIV Prevention and Care, Mobile Health Technology (mHealth), Adherence
- Trial name
- NCT07146139
- Testing
- MyPrEP Plus Package, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
Prevention
Optimizing PrEP Uptake & Adherence Among Male Sex Workers (MSW) Using a 2-stage Randomization Design
"PrEPare for Work" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Male Sex Workers (MSW).
- Trial name
- NCT03086057
- Testing
- PrEPare for Work: Strength Based Case Management (Stage 1), PrEPare for Work: Adherence Training and Counseling (Stage 2)
- Where
- 2 sites in United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Brown University
Adherence to Medication Regime
Early Antiretroviral Therapy and Pre-exposure Prophylaxis for HIV Prevention Among Female Sex Workers in Cotonou, Benin
In the last few years, early treatment of HIV-infected individuals, or "treatment as prevention (TasP), and pre-exposure prophylaxis with antiretroviral drugs among HIV-negative people at very high-risk of acquiring the infection…
- Trial name
- TasP/PrEP (NCT02237027)
- Testing
- TasP using ART regimen as per Benin guidelines, PrEP using Truvada
- Where
- Benin
- Volunteers
- 361 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Patient Acceptance of Health Care
Acceptability of HIV Oral PrEP Among MSM and TGW
The purpose of this study is to determine the factors associated with acceptability to oral HIV pre-exposure prophylaxis (PrEP) among Thai men who have sex with men (MSM) and transgender women (TGW).
- Trial name
- NCT02855606
- Where
- Thailand
- Volunteers
- 105 people
- Sponsor
- Chiang Mai University
HIV Prevention, Pre-exposure Prophylaxis
Stick2PrEP Cisgender Women and Trans Individuals
Taking a daily anti-HIV pill can protect people from HIV infection. This is called preexposure prophylaxis [PrEP]. Many cisgender women and trans individuals do not know this medication is available; others struggle to take the…
- Trial name
- S2P:CWTI (NCT05165745)
- Testing
- Individualized Feedback
- Where
- United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Columbia University
Sexually Transmitted Diseases, Safe Sex
P3 (Prepared, Protected, emPowered)
P3 (Prepared, Protected, emPowered) is an interactive smartphone app for HIV-uninfected YMSM and YTW that utilizes social networking and game-based mechanics as well as a comprehensive understanding of what constitutes "best…
- Conditions
- Sexually Transmitted Diseases, Safe Sex, Adherence, Medication
- Trial name
- P3 (NCT03320512)
- Testing
- P3, P3+, Control
- Where
- 9 sites in United States
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Sexually Transmitted Infections (STIs), HIV
Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
Objective: To develop and validate a predictive model for acquiring sexually transmitted infections (STIs) in individuals using HIV pre-exposure prophylaxis (PrEP) within the national program providing this strategy.
- Conditions
- Sexually Transmitted Infections (STIs), HIV, PrEP
- Trial name
- STI_PrEPare (NCT06860945)
- Testing
- No Intervention: Observational Cohort
- Where
- 26 sites in Spain
- Volunteers
- 9,000 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario de Valme
HIV/AIDS, Adherence
Monitoring Pre-exposure Prophylaxis for Young Adult Women
Next generation real-time monitoring for PrEP adherence in young Kenyan women
- Trial name
- MPYA (NCT02915367)
- Testing
- SMS Reminders
- Where
- 2 sites in Kenya
- Volunteers
- 348 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Adherence, Medication, Risk Behavior
DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence
The researchers are working with a technology company, AiCure, to develop a smartphone app, DOT Diary, which combines two drug adherence strategies.
- Conditions
- Adherence, Medication, Risk Behavior, Pre-Exposure Prophylaxis, HIV Prevention
- Trial name
- NCT03387462
- Testing
- Emtricitabine / Tenofovir Disoproxil Oral Tablet, DOT Diary mobile app
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.