Clinical trials: Pre-Exposure Prophylaxis of HIV Infection
HIV-1-infection
Postpartum Pre-exposure Prophylaxis (PrEP) Study to Evaluate an Adherence Promotion Package for Postpartum Women on PrEP
The postpartum PrEP study (PPS) seeks to evaluate how best to improve adherence to PrEP in postpartum women and to evaluate how acceptable it is to offer HIV self tests for the participant and partner, and provide enhanced…
- Trial name
- PPS (NCT04897737)
- Testing
- HIVST and enhanced adherence biofeedback, Orasure/UrSure test
- Where
- South Africa
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
HIV
Pre-Exposure Prophylaxis in YMSM
This is an exploratory mixed-methods research study that compares an efficacious behavioral HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention combined with a biomedical intervention (PrEP).
- Trial name
- NCT01033942
- Testing
- coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP, Many Men, Many Voices (3MV)
- Where
- 2 sites in United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV/AIDS
Pre-exposure Prophylaxis (PrEP) at Home
This study is a randomized clinical trial of PrEP@Home, a home care system for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP).
- Trial name
- PrEP@Home (NCT03569813)
- Testing
- PrEP@Home System, Standard of Care
- Where
- 5 sites in United States
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Emory University
HIV-I Infection
Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women
The investigators will conduct an observational cohort study in 1200 pregnant women who will be recruited at the first antenatal care (ANC) visit from the Gugulethu and one additional facility in the Klipfontein-Mitchell's Plain…
- Trial name
- PrEP-PP (NCT03902418)
- Testing
- emtricitabine/tenofovir
- Where
- South Africa
- Volunteers
- 1,195 people
- Sponsor
- University of California, Los Angeles
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-1 Infections, HIV Infections
Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples.
- Trial name
- Partners PrEP (NCT00557245)
- Testing
- Tenofovir Disoproxil Fumarate (TDF), Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
- Where
- 9 sites in Kenya, Uganda
- Volunteers
- 4,758 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP)
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV.
- Trial name
- ADAPT (NCT01327651)
- Testing
- Daily dosing, Time-driven dosing, Event-driven dosing
- Where
- 3 sites in United States, South Africa and 1 more
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
HIV Infections
Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum
The purpose of this study was to evaluate the pharmacokinetics, feasibility, acceptability, and safety of a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) as oral daily pre-exposure…
- Trial name
- NCT03386578
- Testing
- Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Behavioral HIV risk reduction package, Enhanced adherence support
- Where
- 7 sites in Malawi, South Africa and 2 more
- Volunteers
- 780 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Prevention, Transgender Health
Study of Truvada for HIV Pre Exposure Prophylaxis Using Daily Directly Observed Therapy to Look at Potential Interactions Between Truvada and Hormone Therapy
Truvada (Emtricitabine or FTC and tenofovir disoproxil fumarate or TDF) has been approved for HIV prevention since 2012. Drug concentrations after receipt of oral Truvada for HIV Pre Exposure Prophylaxis (or PrEP) appeared to be…
- Trial name
- I-BrEATHe (NCT04050371)
- Testing
- 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV Infections
The Women TAF-FTC Benchmark Study
The study seeks to assess the safety of and define blood and tissue benchmark concentrations of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) in cisgender women using directly observed oral pre-exposure…
- Trial name
- NCT05140954
- Testing
- co-formulated 25mg TAF/ 200mg FTC
- Where
- Kenya
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV Infections
Assessment of Pre-Exposure Prophylaxis (PrEP) Administered at Sexually Transmitted Disease (STD) Clinics
This study will assess the uptake, acceptability, safety, and feasibility of HIV pre-exposure prophylaxis (PrEP), consisting of a once-daily fixed-dose combination tablet of emtricitabine (FTC)/tenofovir disoproxil fumarate…
- Trial name
- NCT01632995
- Testing
- FTC 200 mg/TDF 300 mg fixed-dose combination tablet
- Where
- 3 sites in United States
- Volunteers
- 557 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM)
Approximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine Trial Units (AMTUs).
- Trial name
- NCT01769456
- Testing
- PCC, Emtricitabine/tenofovir (FTC/TDF (Truvada®))
- Where
- 6 sites in United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Sexually Transmitted Diseases, Safe Sex
P3 (Prepared, Protected, emPowered)
P3 (Prepared, Protected, emPowered) is an interactive smartphone app for HIV-uninfected YMSM and YTW that utilizes social networking and game-based mechanics as well as a comprehensive understanding of what constitutes "best…
- Conditions
- Sexually Transmitted Diseases, Safe Sex, Adherence, Medication
- Trial name
- P3 (NCT03320512)
- Testing
- P3, P3+, Control
- Where
- 9 sites in United States
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
Adherence, Medication, Risk Behavior
DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence
The researchers are working with a technology company, AiCure, to develop a smartphone app, DOT Diary, which combines two drug adherence strategies.
- Conditions
- Adherence, Medication, Risk Behavior, Pre-Exposure Prophylaxis, HIV Prevention
- Trial name
- NCT03387462
- Testing
- Emtricitabine / Tenofovir Disoproxil Oral Tablet, DOT Diary mobile app
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
HIV
PrEP, Lube, and the Rectal Mucosa in MSM at Risk of HIV
The purpose of this study is to determine whether the use of rectal lubricants can affect how well the medication, Truvada, will work to prevent infection with HIV when someone is exposed to HIV in the rectum.
- Trial name
- NCT02401230
- Testing
- Truvada, Gel lubricant
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Emory University
HIV Prevention
Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP
This is a randomized controlled trial of a multi-level intervention to prevent HIV acquisition among transgender women (N=400) in São Paulo, Brazil.
- Trial name
- PRISM Brazil (NCT04114955)
- Testing
- Manas por Manas
- Where
- 2 sites in Brazil
- Volunteers
- 392 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP).
- Trial name
- EBONI (NCT05514509)
- Testing
- APRETUDE, Cabotegravir tablet
- Where
- 22 sites in United States
- Volunteers
- 295 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Sexually Transmitted Diseases
A Trial to Compare Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men (MSM) Taking HIV Pre-Exposure Prophylaxis (PrEP)
The study involves a randomized placebo controlled trial that aims to assess if a mouthwash (Listerine cool mint, LCM) is able to reduce the cumulative incidence of gonorrhoea (Ng), chlamydia (Ct) and syphilis in men who have sex…
- Trial name
- PReGo (NCT03881007)
- Testing
- Mouthwash with LCM
- Where
- Belgium
- Volunteers
- 343 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
HIV/AIDS
Developing a Patient Navigation Intervention for PrEP Continuum of Care Among Young Latino MSM (PrEParate)
This study aims to help young Latino gay and bisexual men access sexual health information, including PrEP. Participants will be randomly assigned to either the patient navigation or the usual care condition and followed for 6…
- Trial name
- NCT04048382
- Testing
- Patient Navigation, Usual Care
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- San Diego State University