Clinical trials: HIV Pre-Exposure Prophylaxis
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
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing HIV infection, in adolescent girls and young women (AGYW).
- Trial name
- PURPOSE 1 (NCT04994509)
- Testing
- Oral Lenacapavir (LEN), Subcutaneous (SC) Lenacapavir (LEN), F/TAF
- Where
- 28 sites in South Africa, Uganda
- Volunteers
- 5,368 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
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, 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
HIV
Likely Use of PrEP for African American YMSM
HIV Pre-Exposure Prophylaxis (PrEP), in the form of the anti-retroviral pill Truvada©, has been approved by the FDA as a method for reducing HIV transmission rates in the population, particularly young men who have sex with men…
- Trial name
- NCT02810249
- Testing
- No intervention used
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Duke University
HIV Infection
Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).
This is a prospective observational cohort sub-study of subjects enrolled in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 (NCT01772823) or ATN 113 (NCT01769456), which is a prospective…
- Trial name
- NCT01769469
- Testing
- FTC/TDF (Truvada®)
- Where
- 12 sites in United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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 Prevention
The PrEPARE Project: Prevention, Empowering, and Protecting Young Women in South Africa
The project seeks to determine whether implementing a multilevel, woman-focused intervention, the Young Women's Health CoOp (YWHC), for pre-exposure prophylaxis (PrEP) readiness, uptake, and adherence is a viable complement to…
- Trial name
- NCT04048551
- Testing
- Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum, Young Women's Health CoOp (YWHC)
- Where
- South Africa
- Volunteers
- 802 people, healthy volunteers welcome
- Sponsor
- RTI International
Mother to Child HIV Transmission
HIV Diagnosis and Treatment at Birth for Newborn With High Risk HIV Exposure
Principal objective Assess the operational efficacy of a strategy combining early diagnosis and preventive antiretroviral treatment systematically reinforced from the birth* among infants at high risk of infection with HIV** .
- Trial name
- DIAVINA (NCT03642704)
- Testing
- Reinforced preventive ARV therapy
- Where
- Guinea
- Volunteers
- 56 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Pre-Exposure Prophylaxis, HIV
PrEPTECH Phase 2 Study of a PrEP Telehealth Intervention
PrEPTECH Phase 2 is a 2-arm randomized controlled trial to assess the effectiveness of a telehealth intervention in increasing PrEP uptake among cisgender men and transgender women who have sex with men over six months.
- Conditions
- Pre-Exposure Prophylaxis, HIV, Telemedicine
- Trial name
- PrEPTECH2 (NCT04902820)
- Testing
- PrEPTECH website, Online PrEP resource list
- Where
- United States
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- ETR Associates
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: If taking MK-8527 once a month works to prevent HIV-1 infection as well as or…
- Trial name
- NCT07044297
- Testing
- MK-8527, FTC/TDF
- Where
- 81 sites in United States, Argentina and 14 more
- Volunteers
- 4,390 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Adherence, Patient, Pre-Exposure Prophylaxis
mHealth Technologies to Enhance PrEP Adherence Among Thai MSM
This study aims to: 1) adapt the theory-based P3 (Prepared, Protected, emPowered) app designed to improve pre-exposure prophylaxis (PrEP) adherence, retention in PrEP clinical care, and PrEP persistence among young gay, bisexual…
- Conditions
- Adherence, Patient, Pre-Exposure Prophylaxis, HIV/AIDS
- Trial name
- P3-T (NCT04413708)
- Testing
- P3-T PrEP Adherence App
- Where
- Thailand
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Duke University
HIV Negative People Identified at Substantial Risk for HIV Infection
PrEP Demonstration Study in Swaziland
This stepped-wedge cluster-randomized trial is embedded in an 18-month observational cohort study that has the aim to assess the operationalization of oral Pre-Exposure Prophylaxis (PrEP) in Swaziland as an additional HIV…
- Trial name
- NCT03254550
- Testing
- PrEP Promotion Package
- Where
- 6 sites in Eswatini
- Volunteers
- 517 people, healthy volunteers welcome
- Sponsor
- Clinton Health Access Initiative Inc.
IPV, HIV
Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health
This study will test the effectiveness of a youth-designed multilevel intervention, Tu'Washindi, to increase PrEP use and reduce intimate partner violence (IPV) among Kenyan AGYW and to identify implementation challenges and…
- Conditions
- IPV, HIV, PrEP
- Trial name
- NCT05599581
- Testing
- Tu'Washindi
- Where
- 2 sites in Kenya
- Volunteers
- 1,562 people, healthy volunteers welcome
- Sponsor
- RTI International
Pre-Exposure Prophylaxis
Developing mHealth to Promote PrEP Use Among Thai Young Vulnerable Adolescents and Emerging Adults
The main aim of this study is to develop technology-based interventions to improve HIV pre-exposure prophylaxis (PrEP) uptake and adherence among Thai young transgender women.
- Trial name
- NCT05262426
- Testing
- Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Enhanced YaCool, Standard PrEP Counseling
- Where
- 3 sites in Thailand
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Worcester
HIV/AIDS, Gender
Transgender Youth and PrEP: PK, Safety, Uptake & Adherence - Demonstration Project
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
- NCT04077151
- Testing
- PrEP Demonstration Project
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Hektoen Institute for Medical Research
HIV/AIDS
The Prevention Options for Women Evaluation Research (POWER) Cohort
The POWER Cohort study is a PrEP implementation project to demonstrate Pre-exposure prophylaxis (PrEP) delivery for young women in Cape Town and Johannesburg, South Africa and Kisumu, Kenya.
- Trial name
- NCT03490058
- Testing
- Truvada
- Where
- 3 sites in Kenya, South Africa
- Volunteers
- 2,255 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infection
Factors Affecting PrEP Adherence
The purpose of this study is to test a new way to take a questionnaire that asks about adherence (whether the person is taking the medicine correctly). This new questionnaire is called Interactive Questionnaire System (iQS).
- Trial name
- NCT02411630
- Testing
- Emtricitabine/tenofovir disoproxil
- Where
- 12 sites in United States
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill