Clinical trials: Pre-exposure Prophylaxis (PrEP)
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
Human Immunodeficiency Virus (HIV), HIV Pre-exposure Prophylaxis
HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics
This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.
- Trial name
- HTS PrEP (NCT07089966)
- Testing
- HTS counselor-led PrEP care model
- Where
- Kenya
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Preexposure Prophylaxis
The SwissPrEPared Study
Nested within the SwissPrEPared Program, the "SwissPrEPared Study" - a large, multicentric, nation-wide cohort study - aims to longitudinally follow individuals asking for PrEP prescription over a period of 3 years.
- Trial name
- NCT03893188
- Where
- 41 sites in Switzerland
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- University of Zurich
HIV, STIs
Combatting HIV Or Other STIs Early (CHOOSE)
The overarching goal of this project is to optimize the PrEP Choice integrated mHealth package and assess the efficacy and cost of PrEP Choice on PrEP initiation and adherence among young people.
- Conditions
- HIV, STIs, STIs Prevention, HIV Prevention
- Trial name
- CHOOSE (NCT07510048)
- Testing
- Standard of care and PrEP Choice at Enrollment, Standard of care followed by PrEP Choice at Month 9
- Where
- 6 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Westat
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
Advanced HIV Prevention (PrEP Chicago)
This study will evaluate the feasibility of a network intervention to train individuals to disseminate PrEP information and motivate initial PrEP interest and knowledge of PrEP in their social networks.
- Trial name
- NCT02896699
- Testing
- PrEP Intervention Group, Control Group
- Where
- United States
- Volunteers
- 424 people, healthy volunteers welcome
- Sponsor
- University of Chicago
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
PrEP Uptake
MI-based PrEP Intervention
Gay, bisexual and other men who have sex with men (MSM) are the group at highest risk of HIV infection in the United States. Pre-exposure prophylaxis (PrEP) has demonstrated high efficacy in preventing HIV infection among MSM.
- Trial name
- NCT03313765
- Testing
- Motivational interviewing (MI), Standard-of-care
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- The Miriam Hospital
Hiv
Mhealth for PrEP Adherence by Young Adult MSM, Phase 2
This Phase 2 project aims to enhance and test a mobile health intervention designed to increase adherence to the daily PrEP pill among culturally-diverse young adult men who have sex with men.
- Trial name
- NCT04633200
- Testing
- DOT mobile app
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Environment and Health Group, Inc.
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/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
Behavior, Health
Online Network Intervention to Increase HIV Pre-exposure Prophylaxis Intention
HIV pre-exposure prophylaxis (or PrEP) is an effective additional preventative measure for reducing the risk of HIV transmission.
- Trial name
- NCT04771312
- Testing
- Mobile app information-only intervention, Mobile app social support network intervention
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Adherence, Medication, Adolescent Behavior
Youth-focused Strategies to Promote Adherence to Pre-exposure Prophylaxis Among Youth At-risk for HIV in Thailand
A randomized controlled clinical trial looking at the effect of use of a mobile phone application in addition to standard care compared to standard care alone at a youth-friendly clinic in young men who have sex with men and…
- Conditions
- Adherence, Medication, Adolescent Behavior, HIV Prevention, Sexual Health
- Trial name
- YouthPrEP (NCT03778892)
- Testing
- 'Project Raincoat' Mobile Phone Application
- Where
- Thailand
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
HIV-1 Infections
HIV PrEP Priming of Immune Effectors
Can HIV-specific immunity develop in HIV uninfected humans exposed to HIV whilst receiving antiretroviral pre-exposure prophylaxis (PrEP)? Investigators will investigate this possibility in commercial sex workers in Kampala who…
- Trial name
- PREPPIE (NCT02593409)
- Testing
- TDF/FTC
- Where
- Uganda
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
HIV
Implementation and Deliver of Lenacapavir for PrEP in a Community Pharmacy Setting
This is an open-label, single center study to evaluate implementation of a pharmacist-managed delivery of L4P in a community pharmacy setting and the impact of twice-yearly vs. quarterly PrEP visits on STI rates.
- Trial name
- L4PinPharm (NCT07210125)
- Testing
- Lenacapavir long-acting, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Kelley-Ross & Associates, Inc.
Major Depressive Disorder in Patients Taking PrEP
Mental Health and PreP
According to ANSM, by June 2023, almost 85,000 people living in France had initiated medical monitoring for HIV PrEP since 2016.
- Trial name
- SAM-P (NCT06944691)
- Testing
- Major depressive disorder scale
- Volunteers
- 600 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
HIV Prevention
Optimizing Pre-Exposure Prophylaxis (PrEP) Among Latino Men Who Have Sex With Men (MSM) in Puerto Rico
To develop, assess and compare the effectiveness of a Motivational Interviewing Intervention for increasing Pre-Exposure Prophylaxis (PrEP) uptake among Latino eligible men in Puerto Rico.
- Trial name
- NCT05804461
- Testing
- Motivational Interviewing
- Where
- Puerto Rico
- Volunteers
- 182 people, healthy volunteers welcome
- Sponsor
- University of Puerto Rico
HIV/AIDS, Gender
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - PK Study
To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases.
- Conditions
- HIV/AIDS, Gender, Behavior and Behavior Mechanisms
- Trial name
- NCT03652623
- Testing
- TDF/FTC
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Hektoen Institute for Medical Research
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
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