Clinical trials: PrEP
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
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
HIV Infections
Assessment of Pre-Exposure Prophylaxis (PrEP) Administered at Sexually Transmitted Disease (STD) Clinics
This study will assess the uptake, acceptability, safety, and feasibility of HIV pre-exposure prophylaxis (PrEP), consisting of a once-daily fixed-dose combination tablet of emtricitabine (FTC)/tenofovir disoproxil fumarate…
- Trial name
- NCT01632995
- Testing
- FTC 200 mg/TDF 300 mg fixed-dose combination tablet
- Where
- 3 sites in United States
- Volunteers
- 557 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Prevention
Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky
The overarching goal of this study is to adapt and feasibility test an evidence-based strengths-based case management (SBCM) intervention for pre-exposure prophylaxis (PrEP) initiation, and examine preliminary efficacy of the…
- Trial name
- NCT05037513
- Testing
- SBCM-PrEP, CDC-PrEP
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Hilary L Surratt, PhD
HIV, Hypertension
SEARCH SAPPHIRE Phase A: A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
The randomized trials in this record will assess effectiveness, fidelity and cost of prevention and treatment interventions for HIV and hypertension with the objective of informing a population-based study of multi-sectored…
- Conditions
- HIV, Hypertension, Alcohol Drinking, Maternal Child Health
- Trial name
- SAPPHIRE PhA (NCT04810650)
- Testing
- Mobility Dynamic Treatment Intervention, Health Living Intervention for Heavy Alcohol Users, Hypertension Linkage
- Where
- 2 sites in Kenya, Uganda
- Volunteers
- 2,233 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV-I, Human Immunodeficiency Virus Type 1
Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)
This study will evaluate whether oral islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection.
- Conditions
- HIV-I, Human Immunodeficiency Virus Type 1, Prophylaxis
- Trial name
- Impower-022 (NCT04644029)
- Testing
- Islatravir, FTC/TDF
- Where
- 24 sites in United States, South Africa and 1 more
- Volunteers
- 730 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV Prevention
The Shauriana Intervention for GBMSM in Kenya
The Shauriana intervention, developed from qualitative work using a community-based participatory approach, aims to integrate PrEP, sexual health, and mental health support for gay, bisexual, and other men who have sex with men…
- Trial name
- NCT04550221
- Testing
- Shauriana
- Where
- Kenya
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infection
An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM)
Approximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine Trial Units (AMTUs).
- Trial name
- NCT01769456
- Testing
- PCC, Emtricitabine/tenofovir (FTC/TDF (Truvada®))
- Where
- 6 sites in United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Health Behavior, Risky, Health Knowledge, Attitudes, Practice
Sistas Informing Sistas on Topics About AIDS and Prevention (SISTA-P)
In this project, the investigators will provide a new HIV prevention training and empowerment sessions to Black women in Washington D.C., Atlanta and New Orleans, who are at high risk for getting HIV.
- Conditions
- Health Behavior, Risky, Health Knowledge, Attitudes, Practice, Health-Related Behavior
- Trial name
- SISTA-P (NCT06307028)
- Testing
- SISTA-P Intervention
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Rutgers, The State University of New Jersey
HIV, Tuberculosis
Sustainable East Africa Research in Community Health
The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach.
- Conditions
- HIV, Tuberculosis, Hypertension, Diabetes
- Trial name
- SEARCH (NCT01864603)
- Testing
- Universal ART in a streamlined care model, Annual Community Health Campaigns, Targeted PrEP and Targeted testing interventions
- Where
- 3 sites in Kenya, Uganda
- Volunteers
- 150,395 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Sexually Transmitted Diseases, Safe Sex
P3 (Prepared, Protected, emPowered)
P3 (Prepared, Protected, emPowered) is an interactive smartphone app for HIV-uninfected YMSM and YTW that utilizes social networking and game-based mechanics as well as a comprehensive understanding of what constitutes "best…
- Conditions
- Sexually Transmitted Diseases, Safe Sex, Adherence, Medication
- Trial name
- P3 (NCT03320512)
- Testing
- P3, P3+, Control
- Where
- 9 sites in United States
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV
A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men
This study consists of a randomized controlled trial (RCT) of a multi-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from…
- Trial name
- NCT04225832
- Testing
- CBT Coping Intervention
- Where
- United States
- Volunteers
- 289 people, healthy volunteers welcome
- Sponsor
- RAND
HIV/AIDS, Adherence
Monitoring Pre-exposure Prophylaxis for Young Adult Women
Next generation real-time monitoring for PrEP adherence in young Kenyan women
- Trial name
- MPYA (NCT02915367)
- Testing
- SMS Reminders
- Where
- 2 sites in Kenya
- Volunteers
- 348 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Adherence, Medication, Risk Behavior
DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence
The researchers are working with a technology company, AiCure, to develop a smartphone app, DOT Diary, which combines two drug adherence strategies.
- Conditions
- Adherence, Medication, Risk Behavior, Pre-Exposure Prophylaxis, HIV Prevention
- Trial name
- NCT03387462
- Testing
- Emtricitabine / Tenofovir Disoproxil Oral Tablet, DOT Diary mobile app
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
Patient Adherence
Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM
CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs. standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection (ClinicalTrials.gov Identifier: NCT01761643).
- Trial name
- CCTG595VitD (NCT02367599)
- Testing
- Vitamin D Supplement
- Where
- 3 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
ART Adherence, PMTCT
HIV Self Testing of Male Partners of Women in PMTCT
The investigators will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits (HIVST) to HIV-positive pregnant women to provide to their male partner, increases the proportion of male partners who…
- Conditions
- ART Adherence, PMTCT, Linkage to Care, HIV
- Trial name
- NCT03484533
- Testing
- HIV self-test kit, Standard of Care (invitation letters for fast-track HIV testing in the clinic)
- Where
- Uganda
- Volunteers
- 736 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV/AIDS
PrEP My Way: A Novel PrEP Delivery System to Meet the Needs of Young African Women
The investigators will first develop, tailor, and refine PrEP My Way for use with young women in Kisumu, Kenya (Aim 1). The design firm will use a client-centered, iterative approach, involving up to 15 individual interviews and…
- Trial name
- NCT04408729
- Testing
- PrEP My Way
- Where
- Kenya
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
HIV
PrEP, Lube, and the Rectal Mucosa in MSM at Risk of HIV
The purpose of this study is to determine whether the use of rectal lubricants can affect how well the medication, Truvada, will work to prevent infection with HIV when someone is exposed to HIV in the rectum.
- Trial name
- NCT02401230
- Testing
- Truvada, Gel lubricant
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Emory University
HIV/AIDS, Pre-exposure Prophylaxis
Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK
Our proposed study will: provide a novel exploration of facilitators and barriers to PrEP; allow us to target hard to reach populations, including men who have sex with men (MSM) and substance users (both of which are top funding…
- Trial name
- NCT04064567
- Testing
- PrEP-LINK, Enhanced Standard of Care
- Where
- 7 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Arkansas
HIV Infections
Storytelling to Increase Family Support for Pre Exposure Prophylaxis Use
Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV infection but requires high levels of medication adherence, particularly among women.
- Trial name
- PrEP (NCT04071470)
- Testing
- Storytelling, PrEP
- Where
- Mozambique
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center