Clinical trials: Pre Exposure Prophylaxis
Hazardous Alcohol Use
PrEP and Alcohol - Enhancing HIV Pre-Exposure Prophylaxis (PrEP)
The present investigation entails a pilot randomized controlled trial to explore whether a stand-alone, alcohol-reduction, brief intervention (with a module on substance use and depression) would be feasible, acceptable, and…
- Trial name
- NCT05097430
- Testing
- Alcohol-focused brief intervention
- Where
- 3 sites in Canada
- Volunteers
- 122 people
- Sponsor
- Centre for Addiction and Mental Health
HIV Prevention
Supporting Oral Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe, Malawi
Purpose: The overall objective of this pilot study is to evaluate the feasibility, acceptability, and appropriateness of a shared decision-making (SDM) intervention to support personally appropriate decision making about PrEP use…
- Trial name
- NCT06394323
- Testing
- Behavioral: My Choice for HIV Prevention (MyChoice)
- Where
- Malawi
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
COVID-19, SARS-CoV-2
Parent Study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA Sub-study)
AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.
- Trial name
- SUPERNOVA (NCT05648110)
- Testing
- AZD5156 (Parent study Sentinel Safety Cohort), EVUSHELD™ (Parent study Main Cohort), AZD3152 (Parent study Main Cohort)
- Where
- 215 sites in United States, Australia and 16 more
- Volunteers
- 3,882 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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
HIV
Pre-Exposure Prophylaxis in YMSM
This is an exploratory mixed-methods research study that compares an efficacious behavioral HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention combined with a biomedical intervention (PrEP).
- Trial name
- NCT01033942
- Testing
- coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP, Many Men, Many Voices (3MV)
- Where
- 2 sites in United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Pre-Exposure Prophylaxis
The Blued+ Combination HIV Prevention Pilot Study in China
The proposed research includes a longitudinal pilot study to assess the feasibility and acceptability of Blued+. This combination HIV prevention intervention will integrate a combination package of HIV prevention services into…
- Trial name
- Blued+ (NCT06647173)
- Testing
- Blued+ Service Platform
- Where
- China
- Volunteers
- 423 people, healthy volunteers welcome
- Sponsor
- Emory University
Pre-Exposure Prophylaxis (PrEP)
eSTEP: An Integrated mHealth Intervention to Engage High-risk Individuals Along the Full PrEP Care Continuum
The long-term goal of this research is to develop a theoretically grounded, effective, accessible and sustainable mHealth PrEP care continuum intervention for men who have sex with men (MSM) and transgender women (TW).
- Trial name
- eSTEP (NCT06159582)
- Testing
- eSTEP, Usual Care
- Where
- United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- San Diego State University
HIV/AIDS
Pre-exposure Prophylaxis (PrEP) at Home
This study is a randomized clinical trial of PrEP@Home, a home care system for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP).
- Trial name
- PrEP@Home (NCT03569813)
- Testing
- PrEP@Home System, Standard of Care
- Where
- 5 sites in United States
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Emory 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 Infections
A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men
The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor currently in development for treatment and…
- Trial name
- NCT03422172
- Testing
- Oral CAB, CAB LA
- Where
- 3 sites in China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
COVID-19
COVID-19 PrEP HCW HCQ Study
Off label study to evaluate the efficacy of HCQ for pre-exposure prophylaxis (PrEP) to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- Trial name
- NCT04354870
- Testing
- Hydroxychloroquine (HCQ)
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- NYU Langone Health
HIV/AIDS
Using Open Contest and Neuro-influence Experiment to Develop and Evaluate PrEP Promotion Messages for High Risk Men
The aim of this study is to examine the utility of neuroimaging technique to evaluate pre-exposure prophylaxis (PrEP) promotion messages for men who have sex with men (MSM) at risk of HIV in Baltimore.
- Trial name
- NCT04166851
- Testing
- PrEP campaign messages developed via open contest, PrEP campaign messages developed via social marketing approach
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
HIV Infections
A Peer-Driven Intervention to Increase PrEP Uptake Among Minority MSM
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.
- Trial name
- NCT05161663
- Testing
- Peer-driven intervention
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- The Miriam Hospital
HIV-1 Infections, HIV Infections
Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples.
- Trial name
- Partners PrEP (NCT00557245)
- Testing
- Tenofovir Disoproxil Fumarate (TDF), Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
- Where
- 9 sites in Kenya, Uganda
- Volunteers
- 4,758 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP)
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV.
- Trial name
- ADAPT (NCT01327651)
- Testing
- Daily dosing, Time-driven dosing, Event-driven dosing
- Where
- 3 sites in United States, South Africa and 1 more
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
HIV Infections
Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum
The purpose of this study was to evaluate the pharmacokinetics, feasibility, acceptability, and safety of a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) as oral daily pre-exposure…
- Trial name
- NCT03386578
- Testing
- Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Behavioral HIV risk reduction package, Enhanced adherence support
- Where
- 7 sites in Malawi, South Africa and 2 more
- Volunteers
- 780 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pre-exposure Prophylaxis, HIV Infections
Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa
The goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (PrEP) use among female sex workers (FSW) and adolescent girls and youth women (AGYW) in uMgungundlovu, KwaZulu-Natal, South…
- Trial name
- NCT06274060
- Testing
- Case management, Food vouchers, PrEP support buddy
- Where
- South Africa
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
HIV Infections, Pre-exposure Prophylaxis
PrEP Readiness Interventions for Supporting Motivation
The overarching goal of this formative research is to examine whether, and in what combination, contingency management (CM) and motivational interviewing (MI) can facilitate entry of stimulant-using men who have sex with men…
- Conditions
- HIV Infections, Pre-exposure Prophylaxis, Substance Use Disorders
- Trial name
- PRISM (NCT04205487)
- Testing
- Motivational Interviewing (MI), Contingency Management (CM)
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Florida International University
HIV Prevention, Transgender Health
Study of Truvada for HIV Pre Exposure Prophylaxis Using Daily Directly Observed Therapy to Look at Potential Interactions Between Truvada and Hormone Therapy
Truvada (Emtricitabine or FTC and tenofovir disoproxil fumarate or TDF) has been approved for HIV prevention since 2012. Drug concentrations after receipt of oral Truvada for HIV Pre Exposure Prophylaxis (or PrEP) appeared to be…
- Trial name
- I-BrEATHe (NCT04050371)
- Testing
- 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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