Clinical trials: Pre-Exposure Prophylaxis (PrEP)
Human Immunodeficiency Virus
Mobile-health (mHealth) Intervention to Support HIV Self-testing and PrEP Uptake Among Young Men Who Have Sex With Men
The proposed study will involve adolescent (17-24 years old) men who have sex with men (described as YMSM hereafter) who meet eligibility criteria to participate.
- Trial name
- NCT04865341
- Testing
- IMB, Information-Only Control
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
Hiv
Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the…
- Trial name
- PrEP-PP (NCT03826199)
- Testing
- TDF-FTC, Counselling on PrEP in antenatal and postnatal care
- Where
- South Africa
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Human Immunodeficiency Virus Transmission, Sexually Transmitted Diseases
The OPENS Trial: Offering Women PrEP (Aim 1)
To address the significant barriers to PrEP implementation for those who were assigned female at birth and self-identify as a woman and address racial inequities in HIV prevention in the United States (US), a novel approach that…
- Trial name
- NCT04621760
- Testing
- HIV Prevention Decision Support Tool (DST), Standard Counseling
- Where
- United States
- Volunteers
- 189 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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
PrEP Adherence Monitoring
IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project
The overall aim of this study is to assess attitudes toward PrEP, feasibility of Truvada PrEP procurement through the established access procedures, and adherence to Truvada PrEP among US women at risk for HIV acquisition.
- Trial name
- NCT03058835
- Testing
- tenofovir disoproxil and emtricitabine
- Where
- 4 sites in United States
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- Rutgers, The State University of New Jersey
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-infection/AIDS
WeExPAnd: PrEP Demonstration Project Among Women at Risk for HIV Infection - Preexposure Prophylaxis (PrEP)
The objective of this application is to increase PrEP uptake among women vulnerable to HIV acquisition in the rural South, specifically those seeking care at Federally Qualified Healthcare Centers (FQHC) in rural Alabama.
- Trial name
- PrEP (NCT04373551)
- Testing
- Cultural adaptation of a patient-provider communication tool
- Where
- United States
- Volunteers
- 67 people
- 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
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP).
- Trial name
- EBONI (NCT05514509)
- Testing
- APRETUDE, Cabotegravir tablet
- Where
- 22 sites in United States
- Volunteers
- 295 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Prevention
Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP
This is a randomized controlled trial of a multi-level intervention to prevent HIV acquisition among transgender women (N=400) in São Paulo, Brazil.
- Trial name
- PRISM Brazil (NCT04114955)
- Testing
- Manas por Manas
- Where
- 2 sites in Brazil
- Volunteers
- 392 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Human Immunodeficiency Virus
Pharmacy-based Pre-exposure Prophylaxis
The proposed research will develop a culturally appropriate pharmacy pre-exposure prophylaxis (PrEP) delivery model for black men who have sex with men (BMSM) who live in high poverty, racial minority neighborhoods.
- Trial name
- NCT04393935
- Testing
- Pharmacy Delivered PrEP Intervention
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Emory University
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 Infections, Syphilis
Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC)
This study proposes to investigate the performance of existing and new technologies for HIV diagnosis, one of the key strategies for Ending the HIV Epidemic in the U.S.
- Trial name
- EHPOC (NCT04793750)
- Testing
- Cepheid GeneXpert HIV-1 Qual POC HIV VL test, DPP HIV-Syphilis test system, OraQuick
- Where
- 3 sites in United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
HIV/AIDS
Biomedical HIV/AIDS Prevention Program Yunnan
B-HAPPY is an implementation project to study the process by which pre-exposure prophylaxis (PrEP) is introduced and integrated into a specific international health system facing high rates of HIV incidence among men who have sex…
- Trial name
- B-HAPPY (NCT03992274)
- Testing
- Enhanced implementation of PrEP
- Where
- China
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Columbia University
Pre-Exposure Prophylaxis
Developing mHealth to Promote PrEP Use Among Thai Young Men Who Have Sex With Men
The goal of this study is to develop and pilot test technology-based interventions to promote Pre-exposure Prophylaxis (PrEP) uptake and adherence among Thai young men who have sex with men (YMSM).
- Trial name
- NCT05243030
- Testing
- Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Motivational Interactive Text Messaging (MTM), Standard PrEP Counseling
- Where
- 3 sites in Thailand
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Worcester
HIV, Violence, Gender-Based
Development and Evaluation of a PrEP Decision Aid for Women Seeking Domestic Violence Services in Baltimore
This study is designed to develop and test an individual decision aid for pre-exposure prophylaxis (PrEP) tailored to Black women who have been exposed to intimate partner violence and are working with a domestic violence service…
- Conditions
- HIV, Violence, Gender-Based, Pre-Exposure Prophylaxis
- Trial name
- NCT05614492
- Testing
- Individual PrEP Decision Aid, CDC PrEP Video, Shared PrEP Decision Aid
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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 Infections
HealthMindr App to Increase Pre-exposure Prophylaxis (PrEP) Uptake and Retention Among Men Who Have Sex With Men (MSM)
This study is a randomized controlled clinical trial of a theoretically based mobile app, HealthMindr, to increase pre-exposure prophylaxis (PrEP) uptake among men who have sex with men (MSM) to prevent human immunodeficiency…
- Trial name
- NCT03763942
- Testing
- HealthMindr App, Control App
- Where
- 3 sites in United States
- Volunteers
- 658 people, healthy volunteers welcome
- Sponsor
- Emory University
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
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