Clinical trials: Pre-Exposure Prophylaxis
Adolescent Behavior, HIV/AIDS
Evaluating The Acceptability and Uptake of Pre-Exposure Prophylaxis (PrEP) for Adolescent Women in The Deep South
This project is designed to 1) develop a PrEP implementation plan for a general adolescent clinic. Investigators will develop a replicable implementation plan for providing PrEP to adolescents in a primary care setting; and 2)…
- Conditions
- Adolescent Behavior, HIV/AIDS, PrEP
- Trial name
- NCT03897725
- Testing
- Telehealth Coaching
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
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
Pre-Exposure Prophylaxis
Leveraging Electronic Health Record Data in a Risk Prediction Model to Increase HIV PrEP Intake in Primary Care
Kaiser Permanente Northern California (KPNC) has been a national leader in implementation of HIV preexposure prophylaxis (PrEP), a daily antiretroviral pill that is more than 99% effective in preventing HIV acquisition.
- Trial name
- NCT05991869
- Testing
- Point-of-care decision support intervention
- Where
- United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente
Safety Issues
Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study
This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days.
- Trial name
- RITE PrEP (NCT06274398)
- Testing
- TAF/EVG rectal insert
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Eastern Virginia Medical School
HIV Infection
Study in Healthy Volunteers of the Safety and Metabolism of Different Doses of the Anti-HIV Drug TMC278LA.
TMC278 (also called rilpivirine) is a new drug being developed to treat HIV. Usually TMC278 is taken as a tablet, by mouth, once a day, but a 'long acting' formulation has been developed so the drug stays in the bloodstream for a…
- Trial name
- NCT01275443
- Testing
- 300mg TMC278LA, 150mg TMC278LA, 1200mg TMC278LA
- Where
- United Kingdom
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- St Stephens Aids Trust
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/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 Prevention, HIV Infection Primary
Intervention to Enhance PrEP Persistence
The investigators will conduct a fully powered randomized controlled trial (RCT) to test the effect of a patient navigation intervention on PrEP initiation, adherence and retention in care.
- Trial name
- NCT06872307
- Testing
- RAMP-It-Up Initiation, Adherence, and Retention Intervention
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Brown University
HIV Infections
Pre-Exposure Prophylaxis Using TMC278LA
Pre-exposure prophylaxis (PrEP) is an experimental HIV-prevention strategy using antiretroviral (ARV) agents to protect HIV negative individuals from HIV infection.TMC278 is a new drug being developed for this type of HIV…
- Trial name
- NCT01049932
- Testing
- TMC278LA
- Where
- 4 sites in United Kingdom
- Volunteers
- healthy volunteers welcome
- Sponsor
- St Stephens Aids Trust
Sex Work, Pre-Exposure Prophylaxis
Centering Those Engaged in Transactional Sex: A PrEP Innovation for Getting To Zero
Using a participatory implementation science framework, I will test whether an adapted and community empowered group healthcare model, Centering PrEP+, is a feasible and acceptable health system intervention to improve the health…
- Trial name
- C-PrEP+ (NCT05929521)
- Testing
- C-PrEP+
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Illinois Chicago
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, STI
Expanded PrEP Implementation in Communities in NSW
A new NSW Ministry of Health HIV Strategy released on 1 December 2015 aims for the virtual elimination of HIV transmission in NSW by 2020.
- Trial name
- EPIC-NSW (NCT02870790)
- Testing
- TDF/FTC
- Where
- 31 sites in Australia
- Volunteers
- 9,733 people, healthy volunteers welcome
- Sponsor
- Kirby Institute
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 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
HIV Infections
FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women
This Phase III, double-blind, randomized, placebo-controlled trial enrolled HIV-negative women from 4 sites in 3 countries (Kenya, Tanzania, South Africa).
- Trial name
- NCT00625404
- Testing
- Truvada
- Where
- 4 sites in Kenya, South Africa and 1 more
- Volunteers
- 2,120 people, healthy volunteers welcome
- Sponsor
- FHI 360
HIV Prevention, Sexually Transmitted Diseases
HOME Study: a Combination Support Package to Increase Uptake of PrEP and HIV/STI Testing
Home HIV self-testing has been FDA approved and allows users to read their own HIV test results at home, while home sexually transmitted infection (STI) test self-collection allows men to use a swab at home and mail it in for…
- Conditions
- HIV Prevention, Sexually Transmitted Diseases, Pre-Exposure Prophylaxis
- Trial name
- NCT03138135
- Testing
- HOME Study intervention, Control
- Where
- United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth…
- Trial name
- PURPOSE 2 (NCT04925752)
- Testing
- Oral Lenacapavir (LEN), F/TDF, Sub-cutaneous (SC) Lenacapavir (LEN)
- Where
- 93 sites in United States, Argentina and 6 more
- Volunteers
- 3,292 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences