Clinical trials: HIV Pre-exposure Prophylaxis
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
Clinician Attitudes About PrEP
Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention
This is a three phase study designed to examine clinician behaviors with regard to recommending and prescribing pre-exposure prophylaxis (PrEP) as a primary Human Immunodeficiency Virus (HIV) prevention strategy, and to identify…
- Trial name
- NCT01751659
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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, STIs
Combatting HIV Or Other STIs Early (CHOOSE)
The overarching goal of this project is to optimize the PrEP Choice integrated mHealth package and assess the efficacy and cost of PrEP Choice on PrEP initiation and adherence among young people.
- Conditions
- HIV, STIs, STIs Prevention, HIV Prevention
- Trial name
- CHOOSE (NCT07510048)
- Testing
- Standard of care and PrEP Choice at Enrollment, Standard of care followed by PrEP Choice at Month 9
- Where
- 6 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Westat
Pre-Exposure Prophylaxis
Optimizing HIV PrEP Through Shared Decision Making
The purpose of this study is to test a clinical Decision Aid that will help patients and providers determine if pre-exposure prophylaxis (PrEP) is the right decision.
- Trial name
- NCT03019770
- Testing
- PrEP Decision Aid
- Where
- 2 sites in United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
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
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
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
Improving Perceptions of HIV Risk, Improving Uptake of Pre-exposure Prophylaxis for HIV
Manicaland PrEP Uptake Through Interactive Counselling Trial
Primary Objective: The purpose of this trial is to evaluate the impact of an interactive tablet based counselling session correcting risk perception and addressing ambiguity around availability, usability and effectiveness of…
- Trial name
- NCT03565575
- Testing
- Interactive tablet-based quiz
- Where
- 8 sites in Zimbabwe
- Volunteers
- 1,055 people, healthy volunteers welcome
- Sponsor
- Simon Gregson
HIV Prevention
Project WERK (Wellness Encouragement Respect Kinship)
The Project WERK intervention is a brief, theory based and culturally sensitive intervention designed to capitalize on organic yet underutilized social support networks in the lives of young black men who have sex with men…
- Trial name
- WERK (NCT03148171)
- Testing
- WERK Supportive Contact
- Where
- United States
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- University of Chicago
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
Pre-Exposure Prophylaxis
Zambia Healthy Choices Project for Emerging Adults Living With HIV
This project will develop and implement a multi-component intervention using mobile health technology to improve HIV self-management and reduce substance use.
- Trial name
- NCT06415357
- Testing
- Mobile Healthy Choices (mHC), Motivational Text Messaging (MTM), Standard ART Counseling
- Where
- Zambia
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Worcester
HIV - Human Immunodeficiency Virus
HIV Prevention With PrEP Among People on Opioid Replacement Therapy
The purpose of this study is to assess the feasibility and acceptability of providing oral pre-exposure prophylaxis (PrEP) and opioid agonist therapy (OAT) simultaneously in existing pharmacy-based programs operating in Alberta…
- Trial name
- OAT-PrEP (NCT07160075)
- Testing
- Simultaneous administration of OAT and oral PrEP at existing pharmacy-based programs
- Where
- 6 sites in Canada
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Cara Spence
HIV Infections
The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir
Although CAB LA PrEP has been proven efficacious in blinded randomized controlled clinical trials, additional research is needed to evaluate effectiveness in real world settings as well as to identify effective implementation…
- Trial name
- ImPrepCab (NCT05515770)
- Testing
- Cabotegravir Injection
- Where
- Brazil
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Evandro Chagas National Institute of Infectious Disease
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