Clinical trials: Pre-Exposure Prophylaxis
HIV Prevention
Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women
This is an open-label, steady-state study of Tenofovir (TFV) and Emtricitabine (FTC) pharmacokinetics (PK) in transgender women taking feminizing hormones.
- Trial name
- NCT03060785
- Testing
- Tenofovir Disoproxil Fumarate/Emtricitabine
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Relationship Dynamics, Pre-exposure Prophylaxis (PrEP) Adherence
CHARISMA Expansion Study
The CHARISMA Expansion Study is a two-arm, randomized (1:1), controlled study of a behavioral intervention-the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA)-to reduce social…
- Trial name
- CHARISMA (NCT04092114)
- Testing
- Control, CHARISMA Intervention
- Where
- South Africa
- Volunteers
- 407 people, healthy volunteers welcome
- Sponsor
- RTI International
Improving Perceptions of HIV Risk, Improving Uptake of Pre-exposure Prophylaxis for HIV
Manicaland PrEP Uptake Through Interactive Counselling Trial
Primary Objective: The purpose of this trial is to evaluate the impact of an interactive tablet based counselling session correcting risk perception and addressing ambiguity around availability, usability and effectiveness of…
- Trial name
- NCT03565575
- Testing
- Interactive tablet-based quiz
- Where
- 8 sites in Zimbabwe
- Volunteers
- 1,055 people, healthy volunteers welcome
- Sponsor
- Simon Gregson
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.
Opioid Use Disorder, HIV Infections
Combination Primary Care and Prevention Services for Women Who Inject Drugs and Exchange Sex in Seattle, Washington
The investigators will implement a non-randomized observational clinical trial that will include a pop-up clinic for women who inject drugs (WWID) near venues for exchange sex and drug use in north Seattle.
- Conditions
- Opioid Use Disorder, HIV Infections, Chlamydia, Gonorrhea
- Trial name
- NCT06187064
- Testing
- Mobile Van Clinic
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV, Other STIs
Comparative Effectiveness of Individual Versus Group-Level Interventions to Increase PrEP Uptake and Reduce HIV/STI Incidence
The HIV diagnosis rate among African-born Black women is the highest of all Black individuals living in the US. Correct and consistent use of condoms and use of pre-exposure prophylaxis (PrEP) are two effective means of…
- Trial name
- NCT06022809
- Testing
- Dada Kwa Dada (individual-level), DADA (group-level)
- Where
- 3 sites in United States
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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
HIV Prevention
A Pharmacokinetic Evaluation of Tenofovir/Emtricitabine as HIV Pre-Exposure Prophylaxis in Transgender Women
Human immunodeficiency virus (HIV) persists worldwide as an immense health burden among vulnerable populations. HIV pre-exposure prophylaxis (PrEP) has offered the promise of limiting the global burden of HIV.
- Trial name
- NCT03270969
- Testing
- Tenofovir Disoproxil Fumarate/Emtricitabine
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
HIV, PrEP
Pharmacy-based Provision of Pre-exposure Prophylaxis (PrEP) for Adolescent Girls and Young Women in Tanzania
Implementation study comparing standard pre-exposure prophylaxis (PrEP) services to four models of pharmacy-based PrEP access for young women aged 18-24 (YW) in Tanzania.
- Trial name
- MWOTAJI (NCT07687888)
- Testing
- Pharmacy-based PrEP services, Distribution of HIV self-test kits
- Where
- Tanzania
- Volunteers
- 2,818 people, healthy volunteers welcome
- Sponsor
- Mzumbe University - Centre of Excellence in Health Monitoring and Evaluation
HIV
Exploring HIV Entry Blockade as a Pre-exposure Prophylaxis Strategy in Women
Pre-exposure prophylaxis (PrEP) is an HIV prevention strategy in which HIV medicines are used by a person before they are exposed to HIV in order to decrease his or her chance of getting infected.
- Trial name
- MVC-PREP (NCT01749566)
- Testing
- maraviroc
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Emory University
HIV Prevention
Optimizing PrEP Utilization Among Alcohol and Other Drug (AOD) Using Women of Color
Nationally, the HIV case rate among black/ African American (AA) women is nearly 20 times higher than in white women; for Hispanic/Latino women it is 4.5 times higher.
- Trial name
- NCT04018651
- Testing
- PrEP Master Adherence Intervention
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Florida International University
HIV, Pregnancy
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
Study investigators developed and piloted a counselling intervention, Healthy Families-PrEP, that supports women to use HIV prevention strategies while trying for and during pregnancy.
- Conditions
- HIV, Pregnancy, Pre-Exposure Prophylaxis of HIV Infection
- Trial name
- HFPT (NCT06746675)
- Testing
- Healthy Families PrEP Counselling Intervention
- Where
- Uganda
- Volunteers
- 660 people, healthy volunteers welcome
- Sponsor
- Yale University
HIV/AIDS
Access to PrEP for MSM: Acceptability and Feasibility in Community-based Clinics in West Africa (CohMSM-PrEP)
This demonstration project will assess the acceptability and feasibility of pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) as part of a comprehensive HIV prevention package in community-based clinics in West…
- Trial name
- CohMSM-PrEP (NCT03459157)
- Testing
- HIV prevention package including PrEP
- Where
- 4 sites in Burkina Faso, Côte d’Ivoire and 2 more
- Volunteers
- 649 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
Coronavirus Infection
Randomized Clinical Trial for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel
Healthcare workers are particularly at risk of SARS-CoV-2. This study aims to assess the efficacy of a daily single dose of tenofovir disoproxil fumarate (TDF) (245 mg)/ Emtricitabine (FTC) (200 mg), a daily single dose of…
- Trial name
- EPICOS (NCT04334928)
- Testing
- Emtricitabine/tenofovir disoproxil, Hydroxychloroquine
- Where
- 65 sites in Spain
- Volunteers
- 1,002 people, healthy volunteers welcome
- Sponsor
- Plan Nacional sobre el Sida (PNS)
Cognitive Dysfunction
Adapting a Behavioral Intervention to Accommodate Cognitive Dysfunction in People Who Inject Drugs
The goal of this pilot work was to determine if the cognitive dysfunction accommodation strategies help patients retain/utilize more HIV prevention information and increase PrEP adherence.
- Trial name
- NCT05912374
- Testing
- standard Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB), enhanced Community-Friendly Health Recovery Program- Biobehavioral (CHRP-BB)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Connecticut
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
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
Alcohol Misuse, HIV
Gathering Online for Dialogue and Discussion to Enhance Social Support
The goal of this trial is to test a modified mobile health intervention (with a group component) relative to a mobile health intervention in a two-arm randomized trial with up to 500 young women who are human immunodeficiency…
- Conditions
- Alcohol Misuse, HIV, Sexually Transmitted Infections, Pre-exposure Prophylaxis
- Trial name
- GODDESS (NCT05753683)
- Testing
- mHealth-Women's CoOp, Virtual Group
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- RTI International
HIV Infections
Online Cohort of Sexual and Gender Minorities: Evaluating Digital Interventions to Improve HIV Pre-Exposure Prophylaxis and Antiretroviral Treatment Uptake and Adherence
This study will create and follow an online cohort of sexual and gender minorities in Brazil to better understand the use of HIV prevention and treatment strategies, particularly pre-exposure prophylaxis (PrEP) and antiretroviral…
- Trial name
- NCT07772791
- Testing
- Weekly WhatsApp Adherence Messages
- Where
- Brazil
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Oswaldo Cruz Foundation
HIV
IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya
IPrEP Men's Study is a prospective cohort study enrolling male clients (MC) of female sex workers (FSW) in Kisumu, Kenya. HIV-negative MC participants will be offered oral PrEP (emtricitabine/tenofovir [FTC/TDF]) combined with…
- Trial name
- NCT04898699
- Testing
- UrSure Rapid Urine Tenofovir Test, OraQuick Rapid HIV Self-test kit, Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®]
- Where
- Kenya
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Columbia University