Clinical trials: Pre-Exposure Prophylaxis (PrEP)
HIV
Likely Use of PrEP for African American YMSM
HIV Pre-Exposure Prophylaxis (PrEP), in the form of the anti-retroviral pill Truvada©, has been approved by the FDA as a method for reducing HIV transmission rates in the population, particularly young men who have sex with men…
- Trial name
- NCT02810249
- Testing
- No intervention used
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Duke University
HIV Prevention
Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
This is a single-arm, open-label, effectiveness study designed to evaluate the use of Tenofovir, Lamivudine, and Dolutegravir in people with newly diagnosed HIV-1 infection initiating first-line Antiretroviral Therapy with…
- Trial name
- PICASSO (NCT06485154)
- Testing
- TLD - Tenofovir Disoproxil Fumarate / Lamivudine / Dolutegravir
- Where
- 3 sites in South Africa
- Volunteers
- 100 people
- Sponsor
- University of Witwatersrand, South Africa
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 Pre-exposure Prophylaxis
Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of…
- Trial name
- PURPOSE 365 (NCT07047716)
- Testing
- Lenacapavir Injection, Lenacapavir Tablet
- Where
- 31 sites in United States
- Volunteers
- 339 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
HIV
ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa.
The ALIGN study will evaluate the delivery of injectable Lenacapavir (LEN), a long-acting injectable formulation for HIV pre-exposure prophylaxis (PrEP), amongst adolescents and young people (aged 15-35 years) living within the…
- Trial name
- ALIGN (NCT07390409)
- Testing
- Lenacapavir Injection, Cabotegravir (CAB) LA, Tenofovi-Emtricitabine (TDF/FTC) tablet
- Where
- South Africa
- Volunteers
- 3,700 people, healthy volunteers welcome
- Sponsor
- Desmond Tutu HIV Foundation
HIV, Pre-exposure Prophylaxis
Life Steps for PrEP for Youth
This is a formative study, designed to provide information required to tailor Life-Steps for Pre-Exposure Prophylaxis (PrEP), an evidence-based cognitive behavioral adherence intervention, to enhance PrEP uptake and adherence in…
- Conditions
- HIV, Pre-exposure Prophylaxis, Medication Adherence
- Trial name
- LSPY (NCT03805451)
- Testing
- Life Steps for PrEP for Youth
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Fenway Community Health
HIV Infection
An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM)
Approximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine Trial Units (AMTUs).
- Trial name
- NCT01769456
- Testing
- PCC, Emtricitabine/tenofovir (FTC/TDF (Truvada®))
- Where
- 6 sites in United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Human Immunodeficiency Virus (HIV)
ComBaCaL HIV Prevention TwiCs
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for…
- Trial name
- CoPrev (NCT07581600)
- Testing
- CoPrev model, Referral to the nearest responsible health facility
- Where
- 2 sites in Lesotho, Switzerland
- Volunteers
- healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
HIV/AIDS
The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention
To compare the effect of different PrEP drugs (FTC-TDF and FTC-TAF), doses and timing of doses on p24 antigen level in resected foreskin tissue following HIV exposure ex vivo challenge.
- Trial name
- CHAPS (NCT03986970)
- Testing
- Tenofovir
- Where
- South Africa
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Wits Health Consortium (Pty) Ltd
Human Immunodeficiency Virus (HIV), HIV Pre-exposure Prophylaxis
HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics
This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.
- Trial name
- HTS PrEP (NCT07089966)
- Testing
- HTS counselor-led PrEP care model
- Where
- Kenya
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV-1-infection
Uganda PrEP and Harm Reduction Evaluation
This is an evaluation of programs to integrate PrEP into existing services for PWUD. PrEP will be delivered according to Uganda national guidelines and data from national monitoring and evaluation forms will be leveraged to…
- Trial name
- NCT05040308
- Testing
- Integrating PrEP delivery
- Where
- Uganda
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN…
- Trial name
- PALISADE (NCT06134362)
- Testing
- CAB LA
- Where
- 33 sites in Argentina, Botswana and 10 more
- Volunteers
- 2,996 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV/AIDS, Gender
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Intervention Development
To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases.
- Conditions
- HIV/AIDS, Gender, Behavior and Behavior Mechanisms
- Trial name
- NCT04077138
- Where
- 3 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hektoen Institute for Medical Research
Pre-Exposure Prophylaxis
Optimizing PrEP Adherence for Young Men Who Have Sex With Men
The specific aims of this study are: 1. To explore perceived facilitators and barriers to initiating and adhering to HIV PRE-EXPOSURE PROPHYLAXIS (PrEP) among at-risk YOUNG MEN WHO HAVE SEX WITH MEN (YMSM). 2.
- Trial name
- NCT03493555
- Testing
- Peer Health Navigator for PrEP
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Fenway Community Health
HIV, Sexually Transmitted Diseases
LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men
This study is testing the acceptability and feasibility of a highly interactive mobile application (app) to promote HIV/sexually transmitted infection (STI) testing and uptake of pre-exposure prophylaxis (PrEP) among young men…
- Conditions
- HIV, Sexually Transmitted Diseases, Risk Reduction, Pre-Exposure Prophylaxis
- Trial name
- NCT03177512
- Testing
- LYNX Mobile App
- Where
- 2 sites in United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
Unsafe Sex, IV Drug Usage
Evaluation of Implementation of the Phoenix PrEP (Pre-Exposure Prophylaxis) Access Project for Youth Aged 13-24
This study will evaluate the implementation of a PrEP program for youth aged 13-24 in Phoenix, AZ. Numbers of youth who initiate PrEP, how long they continue with PrEP, and the barriers for youth who are trying to initiate and…
- Trial name
- NCT03637322
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Phoenix Children's Hospital
Adherence, Patient, Pre-Exposure Prophylaxis
mHealth Technologies to Enhance PrEP Adherence Among Thai MSM
This study aims to: 1) adapt the theory-based P3 (Prepared, Protected, emPowered) app designed to improve pre-exposure prophylaxis (PrEP) adherence, retention in PrEP clinical care, and PrEP persistence among young gay, bisexual…
- Conditions
- Adherence, Patient, Pre-Exposure Prophylaxis, HIV/AIDS
- Trial name
- P3-T (NCT04413708)
- Testing
- P3-T PrEP Adherence App
- Where
- Thailand
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Duke University
HIV Infections, Sexually Transmitted Diseases
Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
The purpose of this study is to compare the effectiveness of two mobile health technologies (text messaging or a mobile app) designed to help people take HIV pre-exposure prophylaxis (PrEP) as directed by the clinic.
- Trial name
- PCORI PrEP (NCT04855773)
- Testing
- PrEPmate, Dot Diary
- Where
- 4 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
HIV
Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.
- Trial name
- NCT02732730
- Testing
- Truvada, Drug level counseling at Weeks 8 and 13
- Where
- 3 sites in South Africa, Zimbabwe
- Volunteers
- 451 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
Pre-Exposure Prophylaxis (PrEP), HIV
Peer-led Community-based PrEP Delivery Among Youth in Brazil
The goal of this project is to conduct a series of studies to refine, test, and understand experiences with a peer-led community-based intervention in which youth will be integrated into health care teams and trained to deliver…
- Trial name
- COMPrEP (NCT06661356)
- Testing
- COMPrEP
- Where
- 2 sites in Brazil
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham