Clinical trials: Pre-exposure Prophylaxis
HIV-1-infection, Antenatal Care
An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women
This study is composed of two parallel, pilot randomized groups that will obtain preliminary data about the the acceptability, fidelity, and clinical outcomes associated with a multi-component adherence support strategy for HIV…
- Trial name
- NCT04330989
- Testing
- iNSC and Adherence supporter training
- Where
- Malawi
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Negative People Identified at Substantial Risk for HIV Infection
PrEP Demonstration Study in Swaziland
This stepped-wedge cluster-randomized trial is embedded in an 18-month observational cohort study that has the aim to assess the operationalization of oral Pre-Exposure Prophylaxis (PrEP) in Swaziland as an additional HIV…
- Trial name
- NCT03254550
- Testing
- PrEP Promotion Package
- Where
- 6 sites in Eswatini
- Volunteers
- 517 people, healthy volunteers welcome
- Sponsor
- Clinton Health Access Initiative Inc.
PrEP Uptake
PrEP Optimization Among Women to Enhance Retention and Uptake
Black women experience one of the highest incidences of HIV among all subpopulations in the United States, but pre-exposure prophylaxis (PrEP) use among Black cisgender women is very limited.
- Trial name
- POWER Up (NCT05626452)
- Testing
- PrEP Education, Provider training, EMR Optimization
- Where
- United States
- Volunteers
- 724 people, healthy volunteers welcome
- Sponsor
- University of Chicago
HIV Antibody Positivity, PrEP Uptake
PrEP for Prevention of HIV Transmission Among People Who Inject Drugs in Nairobi, Kenya
The investigators broadly aim at determining barriers and facilitators to PrEP uptake and adherence and retention among the study participants.
- Trial name
- NCT05465265
- Testing
- Navigation into prEP by use of PrEP-UP intervention (provision of PrEP information through 5 counselling sessions, peer support, booking of appointments for PWIDs)
- Where
- Kenya
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- University of Washington
Syphilis, Chlamydia
Pre-exposure Prophylaxis: A Miracle Drug or a Moral Hazard
The investigators study the behavioral consequences of Pre-exposure Prophylaxis or PrEP on sexual health behaviors, sexual health outcomes, and partner selection preferences.
- Conditions
- Syphilis, Chlamydia, Gonorrhea, Sexually Transmitted Diseases
- Trial name
- NCT04325555
- Testing
- PrEP
- Where
- United Arab Emirates
- Volunteers
- 2,647 people, healthy volunteers welcome
- Sponsor
- New York University
Pre-Exposure Prophylaxis
Developing mHealth to Promote PrEP Use Among Thai Young Men Who Have Sex With Men
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).
- Trial name
- NCT05243030
- Testing
- Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Motivational Interactive Text Messaging (MTM), Standard PrEP Counseling
- Where
- 3 sites in Thailand
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Worcester
HIV Infection
An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis
Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU).
- Trial name
- NCT01772823
- Testing
- 3MV, PCC, Emtricitabine/tenofovir (FTC/TDF (Truvada®))
- Where
- 12 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Prevention
Optimizing PrEP Utilization Among Alcohol and Other Drug (AOD) Using Women of Color
Nationally, the HIV case rate among black/ African American (AA) women is nearly 20 times higher than in white women; for Hispanic/Latino women it is 4.5 times higher.
- Trial name
- NCT04018651
- Testing
- PrEP Master Adherence Intervention
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Florida International University
HIV Infections
Optimizing Implementation of Long Acting Injectable PrEP
Our goal is to optimize LAI-PrEP implementation within the context of other PrEP methods. Our strategy is flexible to allow pivot to include forthcoming PrEP dosing options should they become available
- Trial name
- NCT07649551
- Testing
- Plan-Do-Study-Act
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
HIV Prevention
A Pharmacokinetic Evaluation of Tenofovir/Emtricitabine as HIV Pre-Exposure Prophylaxis in Transgender Women
Human immunodeficiency virus (HIV) persists worldwide as an immense health burden among vulnerable populations. HIV pre-exposure prophylaxis (PrEP) has offered the promise of limiting the global burden of HIV.
- Trial name
- NCT03270969
- Testing
- Tenofovir Disoproxil Fumarate/Emtricitabine
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
Sexually Transmitted Infections, Gay
HIV/STD Risk and PrEP Implementation Messaging Among Gay, Bisexual, and Other Men Who Have Sex With Men
The goal of this observational study is to learn about awareness around PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors in men having sex with men.
- Conditions
- Sexually Transmitted Infections, Gay, Pre Exposure Prophylaxis
- Trial name
- MIC-DROP (NCT06183502)
- Testing
- Quantitative survey, HIV and STI testing, Qualitative Assessment
- Where
- 3 sites in United States
- Volunteers
- 675 people, healthy volunteers welcome
- Sponsor
- Emory University
PrEP Uptake
Mixed-methods Protocol for the WiSSPr Study
WiSSPr is a prospective observational cohort study grounded in community-based participatory research principles with a community advisory board (CAB) of key population (KP) civil society organi sations (KP-CSOs) and the Ministry…
- Trial name
- WiSSPr (NCT06898112)
- Testing
- PrEP
- Where
- Zambia
- Volunteers
- 299 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia
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
HIV, Sexually Transmitted Diseases
Mobile-Based Application "MyChoices"
This study is testing the acceptability and feasibility of MyChoices, a mobile application (app), to promote HIV testing and pre-exposure prophylaxis (PrEP) uptake among young men who have sex with men (YMSM).
- Conditions
- HIV, Sexually Transmitted Diseases, Pre-exposure Prophylaxis, Risk Reduction
- Trial name
- NCT03179319
- Testing
- MyChoices
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Fenway Community Health
HIV Infection
On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men
This phase III, multi-centre, comparative, double-blind, randomized trial on 2 parallel groups is designed to evaluate a strategy for the prevention of HIV infection including "on demand" antiretroviral pre-exposure with Truvada…
- Trial name
- IPERGAY (NCT01473472)
- Testing
- Truvada
- Where
- 7 sites in Canada, France
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infections
The Women TAF-FTC Benchmark Study
The study seeks to assess the safety of and define blood and tissue benchmark concentrations of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) in cisgender women using directly observed oral pre-exposure…
- Trial name
- NCT05140954
- Testing
- co-formulated 25mg TAF/ 200mg FTC
- Where
- Kenya
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infection
Demonstrating Safety and Effective Delivery of Daily Oral Pre-exposure Prophylaxis (PrEP) for Sex Workers in India
Female sex workers (FSWs) in India are at high risk of HIV infection, and while correct and consistent condom use is an effective means of preventing HIV transmission, many FSWs have difficulty insisting on their use.
- Trial name
- PrEP-India (NCT02148094)
- Testing
- Truvada
- Where
- 2 sites in India
- Volunteers
- 1,325 people, healthy volunteers welcome
- Sponsor
- University of Manitoba
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, PrEP
Bringing Medicines for HIV Prevention to a Family Planning Clinic
The goal of this clinical trial is to understand what patients and physicians think about providing medications to prevent HIV transmission to patients in a family planning clinic.
- Trial name
- NCT06930508
- Testing
- Patient participant screening, Physician participant training
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Women and Infants Hospital of Rhode Island
HIV Pre-exposure Prophylaxis Use
PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence
PrEP4U is designed as a pragmatic, randomized implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir.
- Trial name
- NCT07335289
- Testing
- Choice of follow up, Follow up via standard clinic
- Where
- 2 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital