Clinical trials: PrEP
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
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 Infections
PrEP Intervention for People Who Inject Substances and Use Methamphetamine
In this study, "PrEP Intervention for people who Inject Substances and Use Methamphetamine" (PRIME), we propose to assess if using video directly observed therapy with real-time contingency management (VDOT-CM) may help people…
- Trial name
- PRIME (NCT04523519)
- Testing
- Video directly observed therapy with contingency management, Integrated Next-Step Counseling
- Where
- United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- San Francisco Department of Public Health
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
The 'Comprehensive Adherence Resource and Empowerment Support' (CARES) Study
The primary aim of this study is to adapt the Comprehensive Adherence Resource and Empowerment Support (CARES) intervention to support adolescent girls and young women (AGYW) aged 16-24 in Zimbabwe and South Africa in effectively…
- Trial name
- CARES (NCT07666139)
- Testing
- Comprehensive Adherence Resource and Empowerment Support' (CARES)
- Where
- 2 sites in South Africa, Zimbabwe
- Volunteers
- 2,100 people, healthy volunteers welcome
- Sponsor
- RTI International
Opioid Use, Opioid-use Disorder
Providing Suboxone and PrEP Using Telemedicine
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe…
- Conditions
- Opioid Use, Opioid-use Disorder, Risk Reduction, Hiv
- Trial name
- NCT04521920
- Testing
- Suboxone, PrEP
- Where
- 3 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Duke University
the Intervention Condition is a Brief Motivational Interviewing Session
Motivational Interviewing for PrEP Uptake
The aim of the proposed supplemental study is to test a single session motivational interviewing (MI) program designed to promote the acceptance and use of PrEP for high-risk young Black men who have sex with men (YBMSM) and to…
- Trial name
- NCT03226496
- Testing
- motivational interviewing
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Richard Crosby
HIV Prevention, PrEP Uptake
Social Media Based Peer-Led Intervention for HIV Prevention
The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of E-PrEP on reaching young men of color who have sex with men (YMCSM) at high-risk of HIV infection to reduce HIV acquisition.
- Trial name
- NCT03213366
- Testing
- E-PrEP- Peer-Led Intervention about PrEP, BxNow - General Health Campaign
- Where
- United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
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
Relationship Dynamics, Pre-exposure Prophylaxis (PrEP) Adherence
CHARISMA Expansion Study
The CHARISMA Expansion Study is a two-arm, randomized (1:1), controlled study of a behavioral intervention-the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA)-to reduce social…
- Trial name
- CHARISMA (NCT04092114)
- Testing
- Control, CHARISMA Intervention
- Where
- South Africa
- Volunteers
- 407 people, healthy volunteers welcome
- Sponsor
- RTI International
Treatment Adherence and Compliance
PrEP iT! Mobile App Intervention
The long-term goal of this research is to create an effective and sustainable program to support retention in PrEP care and PrEP adherence among 18-29 year old men who have sex with men (MSM).
- Trial name
- PrEP iT! (NCT04509076)
- Testing
- PrEP iT! (plus usual PrEP care), Usual PrEP care
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- San Diego State University
COVID-19
Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic
The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.
- Trial name
- PrEP_COVID (NCT04331834)
- Testing
- Hydroxychloroquine
- Where
- Spain
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Barcelona Institute for Global Health
HIV Positive, HIV Seronegative
CCTG 593: Testing and Linkage to Care
This is a CCTG sponsored project to determine if those recently screened for HIV would accept assistance to be linked into appropriate health services.
- Trial name
- NCT01941121
- Testing
- Linkage to PrEP or Care
- Where
- 3 sites in United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego