Clinical trials: HIV Pre-exposure Prophylaxis
HIV/AIDS
The PrEP (Pre-exposure Prophylaxis) SMART Study
The PrEP SMART study is testing a stepped model of scalable adherence support strategies in South African young women who initiate PrEP using a SMART (sequential multiple assignment randomized trial) design.
- Trial name
- NCT04038060
- Testing
- WhatsApp Group, 2-way SMS, Drug level feedback
- Where
- South Africa
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
The Women TDF-FTC Benchmark Study
The study seeks to define the expected blood levels of pre-exposure prophylaxis (PrEP) medications (tenofovir) for cisgender women taking directly observed oral PrEP therapy to understand the frequency of PrEP dosing associated…
- Trial name
- NCT05057858
- Testing
- co-formulated 300 mg TDF/ 200mg FTC
- Where
- Kenya
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males
This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV…
- Trial name
- NCT04692077
- Testing
- Cabotegravir (CAB) tablet, CAB LA, Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet
- Where
- 4 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study (Sibanye Health Project)
The purpose of this study is to evaluate the acceptability and uptake of a combination package of biomedical, behavioral and community-level HIV prevention interventions and services for men who have sex with men (MSM) in South…
- Trial name
- NCT02043015
- Testing
- Condom choices, Condom-compatible lubricant choices, Couples HIV counseling and testing (CVCT)
- Where
- 3 sites in United States, South Africa
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Emory University
HIV Infection
Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV.
- Trial name
- NCT01505114
- Testing
- Maraviroc, Emtricitabine, Tenofovir disoproxil fumarate
- Where
- 13 sites in United States, Puerto Rico
- Volunteers
- 594 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV, Antenatal Care
Enhancing Communication on Relationship Preservation, Safer Conception and PrEP to Promote HIV Testing in Uganda
Our novel communication strategy aims to promote HIV testing in Uganda with reassuring messages about the ability to have stable relationships and healthy families with the increased availability of pre-exposure prophylaxis…
- Conditions
- HIV, Antenatal Care, Antiretroviral Therapy, Pre-Exposure Prophylaxis
- Trial name
- NCT06647797
- Testing
- HOPE Clinical Communication Campaign
- Where
- 2 sites in Uganda
- Volunteers
- 22,359 people, healthy volunteers welcome
- Sponsor
- Children's Mercy Hospital Kansas City
HIV/AIDS
Packaging PrEP to Prevent HIV Among WWID
Evidence suggests women who inject drugs (WWID) are disproportionately vulnerable to HIV. If HIV incidence continues unchecked, 1 in 23 WWID in the United States will acquire HIV.
- Trial name
- NCT03304912
- Testing
- PrEP Education and option to accept a PrEP prescription
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Drexel University
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
Pre-exposure Prophylaxis, HIV Infections
Le Kip Kip: A Campaign to Change Social Norms and Build Sustainable Demand for PrEP Among Women in South Africa
The purpose of this study is to evaluate the impact of a social media campaign and community engagement activities to promote pre-exposure prophylaxis (PrEP) use among young women and to influence community norms around PrEP in…
- Trial name
- NCT05417620
- Testing
- Social Media Campaign, PrEP Champions, Community Mobilization
- Where
- South Africa
- Volunteers
- 601 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Pre-exposure Prophylaxis
Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System
The premise for the study is that a tailored approach for rural young men who have sex with men (YMSM), addressing known barriers of transportation, access to providers, and privacy, is most likely to yield high levels of…
- Trial name
- ePrEP (NCT03729570)
- Testing
- ePrEP
- Where
- 4 sites in United States
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Emory University
HIV, Pre-exposure Prophylaxis
The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China
This study aims to use a mini-application on the popular Chinese social media mobile platform, WeChat, to improve HIV pre-exposure prophylaxis (PrEP) uptake among at-risk men who have sex with men (MSM).
- Trial name
- NCT04426656
- Testing
- Phone application
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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