Clinical trials: PrEP
HIV Positive, HIV Seronegative
CCTG 593: Testing and Linkage to Care
This is a CCTG sponsored project to determine if those recently screened for HIV would accept assistance to be linked into appropriate health services.
- Trial name
- NCT01941121
- Testing
- Linkage to PrEP or Care
- Where
- 3 sites in United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
HIV-1-infection
Uganda PrEP and Harm Reduction Evaluation
This is an evaluation of programs to integrate PrEP into existing services for PWUD. PrEP will be delivered according to Uganda national guidelines and data from national monitoring and evaluation forms will be leveraged to…
- Trial name
- NCT05040308
- Testing
- Integrating PrEP delivery
- Where
- Uganda
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of Washington
Bacterial Recovery of Skin Flora Post-Product Application
In Vivo Patient Preoperative Skin Prep Persistence
The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.
- Trial name
- NCT02447497
- Testing
- 3M CHG/IPA Surgical Skin Preparation - Abdominal Region, Normal Saline - Abdominal Region, 3M CHG/IPA Surgical Skin Preparation - Inguinal Region
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Solventum US LLC
HIV Infections
Evaluation of the Cellular Pharmacology of Tenofovir and Emtricitabine According to HIV Infection Status
Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are two antiretroviral medications used for the treatment and prevention of HIV/AIDS.
- Trial name
- NCT01040091
- Testing
- Emtricitabine (FTC), Tenofovir disoproxil fumarate (TDF), Efavirenz (EFV)
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Gender-Based Violence
Tu'Washindi na PrEP: Adolescent Girls in Kenya Taking Control of Their Health
This study is nested within the ongoing DREAMS (Determined, Resilient, Empowered, AIDS-free, and Safe) initiative in Siaya County, Kenya.
- Trial name
- NCT03938818
- Testing
- Tu'Washindi intervention, Control
- Where
- Kenya
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- RTI International
HIV
PrEP (Pre-exposure Prophylaxis) Stigma and Women Ethnodrama Pre-Test Phase
The investigators will develop and pre-test an ethnodrama intervention designed to transform community member beliefs about and foster support of young cisgender women (YCW) using PrEP.
- Trial name
- NCT06501885
- Testing
- Ethnodrama Intervention
- Where
- Kenya
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Duke University
HIV Infections, Contraception
DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana
This study evaluates strategies to improve access to HIV prevention through the integration of pre-exposure prophylaxis (PrEP) into existing healthcare settings, rather than limiting delivery to specialty clinics.
- Conditions
- HIV Infections, Contraception, PrEP
- Trial name
- DYNAMIC PrEP (NCT07597824)
- Testing
- Observational cohort (PrEP use in real-world settings)
- Where
- Botswana
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Contact With or Exposure to Human Immunodeficiency Virus
ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention
The goal of this study is to learn how well long-acting lenacapavir works to prevent human immunodeficiency virus (HIV) infection in people at higher risk of getting HIV in Brazil.
- Trial name
- ImPrEP LEN (NCT07497594)
- Testing
- Lenacapavir long-acting, Tenofovi-Emtricitabine (TDF/FTC) tablet
- Where
- 8 sites in Brazil
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Oswaldo Cruz Foundation
HIV Infections
Evaluate and Optimize an Online Care Model for PrEP Delivery: Pilot Study
Daily oral pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV acquisition, but uptake in Kenya remains low. Barriers to clinic-based PrEP delivery exist (e.g., long wait times, stigma), thus the delivery of…
- Trial name
- ePrEP Kenya (NCT05377138)
- Testing
- Online PEP/PrEP delivery
- Where
- Kenya
- Volunteers
- 2,357 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP
This international, multi-centre, double-blind vaccine study is a three-arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens i.e.
- Trial name
- PrEPVacc (NCT04066881)
- Testing
- Vaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48), Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48), Control PrEP:TDF/FTC once daily (weeks 0-26)
- Where
- Uganda
- Volunteers
- 1,512 people, healthy volunteers welcome
- Sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
Pre-Exposure Prophylaxis
Leveraging Electronic Health Record Data in a Risk Prediction Model to Increase HIV PrEP Intake in Primary Care
Kaiser Permanente Northern California (KPNC) has been a national leader in implementation of HIV preexposure prophylaxis (PrEP), a daily antiretroviral pill that is more than 99% effective in preventing HIV acquisition.
- Trial name
- NCT05991869
- Testing
- Point-of-care decision support intervention
- Where
- United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente
HIV Infections
The TAIL-PrEP Study
The goal of the TAIL-PrEP study is to understand how to support the safe discontinuation of injectable long-acting cabotegravir (cab-LA) and lenacapavir (LEN) while maximizing the public health impact of biomedical HIV prevention…
- Trial name
- NCT06868641
- Testing
- TAIL-PrEP for patients discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing LEN
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Columbia University
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
TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
TechStep is a three-arm, technology-based randomized controlled trial (RCT), with a stepped care approach, among high-risk HIV-negative transgender feminine, transgender masculine, and gender non-conforming youth and young adults…
- Trial name
- NCT04000724
- Testing
- Text Messaging (Text+Step), WebApp (App+Step), Information/No Step
- Where
- 5 sites in United States
- Volunteers
- 254 people, healthy volunteers welcome
- Sponsor
- Friends Research Institute, Inc.
HIV Infection Primary, Hepatitis, Viral, Human
Seville Cohort of People at Substantial Risk for HIV Infection on Pre-exposure Prophylaxis
Pre-exposure prophylaxis (PrEP) based on tenofovir represents a considerably new preventive intervention that has shown to significantly decrease the number of HIV infections while it enables early diagnosis of HIV and other…
- Conditions
- HIV Infection Primary, Hepatitis, Viral, Human, Sexually Transmitted Infections, Excluding HIV and Hepatitis
- Trial name
- SeVIHPrEP (NCT05492565)
- Testing
- Tenofovir Disoproxil Fumarate 300 MG Oral Tablet
- Where
- Spain
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Hospitales Universitarios Virgen del Rocío
Patient Adherence, HIV Seronegativity
Randomized Controlled Trial of iTAB Plus Motivational Interviewing for PrEP Adherence in Transgender Individuals
CCTG 603 is an open-label, two-arm, randomized (1:1) clinical demonstration project to determine if brief Motivational Interviewing (MI-B) added to a text-message based adherence intervention (iTAB) improves adherence to PrEP…
- Trial name
- NCT03086200
- Testing
- brief Motivational Interviewing
- Where
- 5 sites in United States
- Volunteers
- 263 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
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 Infections
Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa
This is a mixed methods study employing a convergence model triangulation design. Participants in the study will be sexually active young adults starting Pre-exposure Prophylaxis at private pharmacies, who will be offered either…
- Trial name
- AXIS (NCT06138600)
- Testing
- Cabotegravir Injection [Apretude], Tenofovir disoproxil fumarate / emtricitabine (or lamivudine)
- Where
- South Africa
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Witwatersrand, South Africa
HIV, Sexually Transmitted Diseases
LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men
This study is testing the acceptability and feasibility of a highly interactive mobile application (app) to promote HIV/sexually transmitted infection (STI) testing and uptake of pre-exposure prophylaxis (PrEP) among young men…
- Conditions
- HIV, Sexually Transmitted Diseases, Risk Reduction, Pre-Exposure Prophylaxis
- Trial name
- NCT03177512
- Testing
- LYNX Mobile App
- Where
- 2 sites in United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
HIV/AIDS, Gender
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Intervention Development
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
- NCT04077138
- Where
- 3 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hektoen Institute for Medical Research