Clinical trials: PrEP
HIV Pre-Exposure Prophylaxis
Supporting Tailored And Responsive PrEP in Rural North Carolina
This project consists of two phases to be completed over five years. Phase 1 (Aims 1 and 2) will be completed during Years 1-3 (R61).
- Trial name
- STARR-NC (NCT05984030)
- Testing
- PrEP Navigation Services, Telehealth PrEP Services Referral, HealthMpowerment Digital Health Intervention - Enhanced
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.
A prospective, open, multicenter,demonstrative of PrEP, which aims to assess the acceptability, feasibility and safety from chemoprophylaxis co-formulated emtricitabine / tenofovir disoproxil fumarate (FTC / TDF) administered…
- Trial name
- PrEPBrasil (NCT01989611)
- Testing
- emtricitabine / tenofovir 200/300 mg
- Where
- 3 sites in Brazil
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Oswaldo Cruz Foundation
Risk Reduction
Point-of-care Urine Monitoring of Adherence: Testing a Real-Time Urine Assay of Tenofovir in PrEP
Worldwide expansion of pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) will be critical to ending the HIV epidemic.
- Trial name
- PUMA (NCT03935464)
- Testing
- PUMA
- Where
- Kenya
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV, Intravenous Substance Abuse
Implementing PrEP for Women Who Inject Drugs
Women who inject drugs are among the most vulnerable to acquiring HIV, but very few women who inject drugs are prescribed pre-exposure prophylaxis (PrEP) for HIV prevention largely due to barriers within our healthcare system.
- Conditions
- HIV, Intravenous Substance Abuse, Women's Health, Organization and Administration
- Trial name
- NCT05360849
- Testing
- Practice Facilitation
- Where
- United States
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
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
Adherence, Patient
A Comparative Effectiveness Demonstration Project for Linkage and Retention in PrEP Care for Men Who Have Sex With Men
This research is being done to learn more about the differences in engaging, recruiting, linking and adhering to pre-exposure prophylaxis (PrEP) services for men who have sex with other men at risk for HIV in Baltimore City.
- Trial name
- PCA (NCT03442192)
- Testing
- PrEP Care Anywhere Services
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
HIV Prevention
A Pharmacist-run PrEP Program for Women
The primary objective of this study is to evaluate uptake and retention of long acting cabotegravir (LA-CAB) also known as Apretude versus daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) also known as Truvada for…
- Trial name
- OPTIMIZE (NCT05755204)
- Testing
- LA-CAB, TDF/FTC
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Orlando Immunology Center
HIV/AIDS
Navigating Insurance Coverage Expansion (NICE)
The purpose of this research is to measure the effectiveness of an in-person assistance intervention on successful insurance enrollment, types of insurance coverage, rates of linkage to and retention in HIV-related health care…
- Trial name
- NICE (NCT04263441)
- Testing
- NICE Intervention
- Where
- 3 sites in United States
- Volunteers
- 630 people, healthy volunteers welcome
- Sponsor
- University of Chicago
HIV Prevention
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
The study will employ a multilevel combination intervention focused on PrEP initiation and adherence among adolescent girls and young women (AGYW) (aged 15-24) living in HIV hotpots in Uganda.
- Trial name
- NCT07002866
- Testing
- HIV Risk Reduction (HIVRR), PrEP Peer Supporters (PS), Matched Savings Accounts + Financial Literacy (FL)
- Where
- 2 sites in United States, Uganda
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Methamphetamine-dependence, HIV-1-infection
Contingency Management for PrEP Adherence and/or Methamphetamine Use
Use of crystal methamphetamine (MA) leads to changes in sexual risk behavior, adherence to HIV prevention tools, immune response to infection, and tissue inflammation that collectively increase risk for HIV transmission among…
- Trial name
- C-MAX (NCT04563962)
- Testing
- Contingency Management-ART, Contingency Management-Methamphetamine
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Human Immunodeficiency Virus (HIV)
Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
This study identifies social and behavioral factors likely to influence PrEP acceptability and adherence among men who have sex with men (MSM), and collaborates with a community health center to evaluate a two-stage intervention…
- Trial name
- SPARK (NCT02037594)
- Testing
- Sexual Health Counseling, Enhanced Adherence Intervention, PrEP Information (Active Control)
- Where
- United States
- Volunteers
- 438 people, healthy volunteers welcome
- Sponsor
- Hunter College of City University of New York
HIV
Decision Support Tool to Integrate PrEP Into Emergency Departments
This project will explore the development of a personalized decision support tool to assist with pre-exposure prophylaxis (PrEP) initiation and persistence among patients identified in the emergency department (ED) and urgent…
- Trial name
- NCT07279129
- Testing
- Decision support tool, PrEP Delivery
- Where
- 2 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- George Washington University
HIV/AIDS
PrEP Communication Intervention for Female Clients of a Needle Exchange
This study will identify perceptions of PrEP in women who inject drugs (WWIDs) and develop and pilot test a targeted intervention that will be embedded in a large, urban syringe exchange program through an extensive formative…
- Trial name
- NCT03541642
- Testing
- Enhanced Intervention, Basic Intervention
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Temple University
Hiv
Five Point Initiative: A Bundled Implementation Strategy to Address the HIV Epidemic in Black Communities
The purpose of this study is to assess the effectiveness of the FPI bundled implementation strategy in increasing HIV testing, Pre-exposure prophylaxis (PrEP) linkage (e.g., prescription) and knowledge, and condom use/access.
- Trial name
- FPI (NCT06062342)
- Testing
- FPI
- Where
- United States
- Volunteers
- 20,400 people, healthy volunteers welcome
- Sponsor
- University of Miami
Long-acting Injectable Cabotegravir for PrEP, Oral Pre-Exposure Prophylaxis (PrEP)
BetterInfo on Women's PrEP Choices and Outcomes in Malawi
The purpose of this study is to understand PrEP user choices, preferences and implementation impact of the roll-out of long-acting injectable PrEP alongside oral PrEP among women in Blantyre, Malawi.
- Trial name
- NCT07579754
- Testing
- Tracing Strategy
- Where
- Malawi
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Antimicrobial Effect
An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes
This study evaluates the antimicrobial properties of HEXI-PREP by Clinell compared to both a negative and a positive control product.
- Trial name
- NCT03417661
- Testing
- HEXI-PREP By Clinell Wipes, Chloraprep
- Where
- United Kingdom
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Gama Healthcare Ltd.
HIV/AIDS, HIV Infections
Harm Reduction Program For Informal PrEP Users In A Community-based Setting (seguiPrEP)
Pre-Exposure Prophylaxis (PrEP) is a biomedical strategy consisting of the use of antiretroviral therapy by HIV-seronegative people at high risk of acquiring HIV, to prevent the infection.
- Conditions
- HIV/AIDS, HIV Infections, Sexually Transmitted Diseases, Vaccination
- Trial name
- seguiPrEP (NCT03996941)
- Testing
- Harm reduction of informal PrEP use, PrEP follow up based on point of care testing
- Where
- Spain
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- BCN Checkpoint
HIV, Substance Use
Couples Health CoOp Plus
This study addresses HIV prevention and treatment for young couples living in Cape Town, South Africa, through a comprehensive biobehavioral multilevel approach-the Couples Health CoOp Plus (CHC+).
- Conditions
- HIV, Substance Use, Stigma, Social
- Trial name
- CHC+ (NCT05310773)
- Testing
- Community Stigma Awareness and Education Workshop, Couples Health CoOp Plus (CHC+)
- Where
- South Africa
- Volunteers
- 962 people, healthy volunteers welcome
- Sponsor
- RTI International
Human Immunodeficiency Virus (HIV)
Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis
This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight weeks over a 40 week period among sexually active…
- Trial name
- TMC278LA (NCT02165202)
- Testing
- Rilpivirine
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- PATH
HIV/AIDS
Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis for Adoption and Adherence for Black Canadians
Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of African, Caribbean and Black (ACB) Canadian patients Aim 2.
- Trial name
- PrEPDSA (NCT03637244)
- Testing
- Decision Support Aid and PrEP for Black Canadians
- Where
- Canada
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto