Clinical trials: HIV Pre-exposure Prophylaxis
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
HIV-1-infection
10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults
This is an open-label phase 1b clinical trial enrolling people living with HIV (PLWH) who are antiretroviral therapy (ART)-naïve or have not been on ART for > 24 weeks.
- Trial name
- NCT05890963
- Testing
- ART, 10E8.4/iMab, VRC07-523LS
- Where
- Tanzania
- Volunteers
- 20 people
- Sponsor
- David Ho
Human Immunodeficiency Virus
Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries
To stem increasing rates of HIV among gay and bisexual men in Central-Eastern Europe, the feasibility, acceptability, and early efficacy of a culturally adapted evidence-based program to introduce pre-exposure prophylaxis (PrEP)…
- Trial name
- NCT05323123
- Testing
- SPARK, HealthMpowerment, PrEP Education
- Where
- 3 sites in United States, Romania
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Columbia University
Pre-exposure HIV Prophylaxis (PrEP)
Sexual Health Impact of Using Pre-exposure HIV Prophylaxis
Epidemiological and psychosociological survey of people on pre-exposure HIV prophylaxis (PrEP).
- Trial name
- SatisPreP (NCT05269199)
- Where
- 7 sites in France
- Volunteers
- 56 people
- Sponsor
- University Hospital, Clermont-Ferrand
HIV Infections
A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men
The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor currently in development for treatment and…
- Trial name
- NCT03422172
- Testing
- Oral CAB, CAB LA
- Where
- 3 sites in China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV
A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)
This study will evaluate HIV-1 RNA and the presence or absence of resistance at baseline and following seroconversion, assess the frequency of HIV-1 screening and screening method(s) used for evaluation of seroconverters, and…
- Trial name
- NCT01902472
- Where
- United States
- Volunteers
- 172 people
- Sponsor
- Gilead Sciences
HIV Infections
Leveraging the Emergency Department to Engage African American Women in HIV Pre-Exposure Prophylaxis
African American (AA) women are more vulnerable to HIV infection than other women. Truvada, when used as pre-exposure prophylaxis (PrEP), is one of the most effective approaches for HIV prevention; however, PrEP use among AA…
- Trial name
- IWPrEP (NCT03930654)
- Testing
- iPrEP, Usual Care
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
HIV, Human Immunodeficiency Virus
Delivery Optimization for Pre-Exposure Prophylaxis (DO PrEP) Study
The overall goal is to determine whether an end-to-end decentralized delivery service for PrEP is more effective, safe, acceptable, and cost-effective than facility-based PrEP delivery.
- Conditions
- HIV, Human Immunodeficiency Virus, ART
- Trial name
- NCT06176859
- Testing
- HIV PrEP Delivery
- Where
- South Africa
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
HIV Prevention, Pre-exposure Prophylaxis (PrEP)
A Study Evaluating An Integrated Pharmacy Digital Diary and Delivery Strategy to Increase PrEP Use Among MSM and TGW
The PrEP 3D randomized controlled trial (RCT) will study the effectiveness of the PrEP-3D app compared to standard of care for starting pre-exposure prophylaxis (PrEP), continuing PrEP, and adherence to PrEP.
- Conditions
- HIV Prevention, Pre-exposure Prophylaxis (PrEP), Risk Reduction, Adherence, Medication
- Trial name
- PrEP-3D RCT (NCT05474313)
- Testing
- PrEP-3D package, Standard of Care
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
HIV Pre-exposure Prophylaxis Use, Adult
Quality of Sexual Life of PrEP Users
The study will recruit participants on the occasion of their visit in a sexual health center or another HIV pre-exposure prophylaxis (PrEP) facility in France.
- Trial name
- PREP-QUAL-VS (NCT06286527)
- Testing
- anonymous self-administered online questionnaire
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Grenoble
Hepatitis C, HIV Infections
Coaching for HCV and HIV
The objective of this study is to determine the feasibility and acceptability of a peer recovery coach (PRC) intervention to improve linkage to hepatitis C (HCV) and/or human immunodeficiency virus (HIV) care, treatment…
- Conditions
- Hepatitis C, HIV Infections, Opioid-use Disorder
- Trial name
- NCT04314414
- Testing
- PRC brief motivational interview intervention, Phone contact
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Boston Medical Center
HIV Infections
The Women TDF-FTC Benchmark Study
The study seeks to define the expected blood levels of pre-exposure prophylaxis (PrEP) medications (tenofovir) for cisgender women taking directly observed oral PrEP therapy to understand the frequency of PrEP dosing associated…
- Trial name
- NCT05057858
- Testing
- co-formulated 300 mg TDF/ 200mg FTC
- Where
- Kenya
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV
TelePharm PrEP/PEP
In this study, the investigators will evaluate whether introducing a remote nurse to screen, counsel, and guide clients through HIV self-testing (via a telehealth platform) and support interested clients (via SMS) between…
- Trial name
- NCT07561658
- Testing
- Telehealth delivery of pharmacy PrEP/PEP, Standard pharmacy PrEP/PEP delivery
- Where
- Kenya
- Volunteers
- 1,580 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
HIV, Mental Health
Optimizing HIV Pre-exposure Prophylaxis (PrEP) Among Women Who Use Drugs in Tanzania
This study is testing two different approaches to help women who use drugs in Tanzania take and continue using HIV prevention medication called pre-exposure prophylaxis (PrEP).
- Conditions
- HIV, Mental Health, Substance Use (Drugs, Alcohol)
- Trial name
- NCT06835751
- Testing
- Motivational Interviewing for PreP, Common Elements Treatment Approach (CETA) + MI-PrEP
- Where
- Tanzania
- Volunteers
- 123 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
HIV Infections
Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Adolescents
Truvada (emtricitabine/tenofovir disoproxil fumarate, or FTC/TDF) is a type of antiretroviral (ARV) medicine that is commonly used to treat HIV.
- Trial name
- NCT02213328
- Testing
- Truvada
- Where
- 2 sites in South Africa
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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