Clinical trials: PrEP
HIV Infections
One-stop PrEP Care Pathway to Simplify PrEP Delivery in Kenya: The One-Stop PrEP Care Project
The goal of this cluster randomized study is to understand if using a One stop PrEP delivery model can improve the efficiency of PrEP service delivery, reduce the cost of providing PrEP and allow continuation on PrEP.
- Trial name
- NCT05905640
- Testing
- Method of PrEP delivery and consultation
- Where
- Kenya
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- University of Washington
COVID-19
Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic
The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.
- Trial name
- PrEP_COVID (NCT04331834)
- Testing
- Hydroxychloroquine
- Where
- Spain
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Barcelona Institute for Global Health
HIV Prevention
The CATALYST Study
The CATALYST study is an implementation study that will characterize and assess the implementation of an enhanced service delivery package providing informed choice of pre-exposure prophylaxis (PrEP) products among women at…
- Trial name
- NCT05937698
- Where
- 28 sites in Kenya, Lesotho and 3 more
- Volunteers
- 6,069 people, healthy volunteers welcome
- Sponsor
- FHI 360
Hiv
Increasing PrEP With Trans Women in the Deep South
The goal of this to address barriers and facilitators to PrEP uptake, and encourage adherence among trans women via a single arm stepped wedge clinical trial.
- Trial name
- T'Cher (NCT05689281)
- Testing
- Peer PrEP Navigation
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- CrescentCare
Safety Issues
Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study
This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days.
- Trial name
- RITE PrEP (NCT06274398)
- Testing
- TAF/EVG rectal insert
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Eastern Virginia Medical School
HIV Infections, Substance Use
Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH)
This randomized Type 1 hybrid effectiveness-implementation trial (N=186) will evaluate the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEP/ART…
- Trial name
- PUSH (NCT06501781)
- Testing
- Peer Activate-LAI, Standard of Care HIV treatment or prevention with LAI-PrEP/ART
- Where
- 2 sites in United States
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Pre-exposure Prophylaxis, HIV
Predictors of Health Service Utilizations Among Key Population in Washington DC
The primary objective of the proposed study is to investigate how PrEP use might result in an increase in the utilization of health and social services offered at a local community-based organization.
- Conditions
- Pre-exposure Prophylaxis, HIV, Health Behavior
- Trial name
- NCT06046079
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Us Helping Us, People Into Living, Inc.
Hiv, Sexually Transmitted Infection
Expanding PrEP By Embedding Unannounced SNAPS Navigators in High STI Testing Clinical Sites
The goal of this study is to assess the impact of an intervention, known as SNAPS, to expand Preexposure Prophylaxis (PrEP) prescriptions at Health + Hospitals (H+H)/Bellevue.
- Trial name
- NCT04207151
- Testing
- SNAPS intervention
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
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
HIV Prevention
PrEP Restart for Adolescent Girls and Young Women Using STI Self Testing and Assessment of Risk
This is a pilot randomized trial among 50 AGYW (aged ≥16≤18 years), who discontinued PrEP use within the past 6 months, assigned in a 1:1 ratio to receive: 1) STI self-test kits (Neisseria gonorrhoea (NG), Chlamydia trachomatis…
- Trial name
- PALESA (NCT06030856)
- Testing
- STI test kits (NG, CT and TV) for home use, Self Administered Behavioural Risk Assessment
- Where
- South Africa
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Wits RHI Research Centre Clinical Research Site
HIV Pre-exposure Prophylaxis
Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of…
- Trial name
- PURPOSE 365 (NCT07047716)
- Testing
- Lenacapavir Injection, Lenacapavir Tablet
- Where
- 31 sites in United States
- Volunteers
- 339 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
HIV/AIDS, PrEP
Pre-Exposure Prophylaxis in the Emergency Department
Despite an increasing armamentarium of behavioral and biomedical HIV prevention methods, since 2010 rates of new infection have remained around 40,000 annually.
- Trial name
- PrEPPED (NCT04429971)
- Testing
- PrEP screening program, PrEP starter pack
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
HIV/AIDS
PrEPared and Strong: Clinic-Based PrEP for Black MSM
Black men who have sex with men (MSM) have among the highest rates of new HIV infections of any group in the United States. Developing effective HIV prevention interventions that work with this group is a critical element of the…
- Trial name
- P&S (NCT02167386)
- Testing
- Enhanced PrEP Adherence, Standard PrEP Adherence
- Where
- 2 sites in United States
- Volunteers
- 204 people, healthy volunteers welcome
- Sponsor
- Columbia University
Hiv
PK of TAF and TDF for PrEP in Pregnant and Postpartum Women
This study will establish benchmarks of TFV-DP concentrations as measures of adherence following daily dosing with Tenofovir Alafenamide (TAF) compared with Tenofovir Disoproxil Fumarate (TDF) during pregnancy and postpartum.
- Trial name
- PrEP-PP PK (NCT04937881)
- Testing
- Tenofovir alafenamide, Tenofovir Disoproxil Fumarate
- Where
- South Africa
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
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
HIV Infections
A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-Risk Populations in Kenya, Africa
This study will evaluate the safety and acceptability of an intermittent and daily PrEP regimen using Tenofovir Disoproxil Fumarate plus Emtricitabine (FTC/TDF) in men and women at risk for HIV, and it will directly compare…
- Trial name
- NCT00971230
- Testing
- FTC/TDF
- Where
- 2 sites in Kenya
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
The goal of this study is to learn whether adults who visit a hospital emergency department (ED) find it acceptable to start HIV pre-exposure prophylaxis (PrEP) during that same visit, with help from a peer navigator.
- Trial name
- RAPID Response (NCT07901101)
- Testing
- RAPID Response peer navigation, Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of South Florida
HIV Pre-exposure Prophylaxis, HIV Prevention and Care
MyPrEP Plus: Development and Pilot Testing of Novel Preexposure Prophylaxis Decision Support Tools for Transgender Women
The primary goal of this randomized controlled trial is to learn if a decision support tool called MyPrEP Plus can help transgender women make decisions about taking pre-exposure prophylaxis (PrEP) for HIV prevention.
- Conditions
- HIV Pre-exposure Prophylaxis, HIV Prevention and Care, Mobile Health Technology (mHealth), Adherence
- Trial name
- NCT07146139
- Testing
- MyPrEP Plus Package, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
HIV Infections
Partners PrEP Program
Through close collaboration with the Ugandan Ministry of Health, the investigators plan to provide PrEP for HIV-negative members of HIV serodiscordant couples by launching PrEP delivery within 12 public ART clinics in Kampala…
- Trial name
- PPP (NCT03586128)
- Testing
- PrEP, ART
- Where
- Uganda
- Volunteers
- 1,381 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections, HSV-2 Infection
Immunogenetic Modulators of Mucosal Protection From HIV-1
This is a single site, prospective, observational study that seeks to assess changes in mucosal immunity that occur as a result of HIV-1 exposure, HSV-2 infection, and/or pre-exposure prophylaxis (PrEP) usage to prevent HIV-1…
- Trial name
- Kinga (NCT03701802)
- Where
- Kenya
- Volunteers
- 812 people, healthy volunteers welcome
- Sponsor
- University of Washington