Clinical trials: Pre-Exposure Prophylaxis of HIV Infection
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 Infection
Demonstrating Safety and Effective Delivery of Daily Oral Pre-exposure Prophylaxis (PrEP) for Sex Workers in India
Female sex workers (FSWs) in India are at high risk of HIV infection, and while correct and consistent condom use is an effective means of preventing HIV transmission, many FSWs have difficulty insisting on their use.
- Trial name
- PrEP-India (NCT02148094)
- Testing
- Truvada
- Where
- 2 sites in India
- Volunteers
- 1,325 people, healthy volunteers welcome
- Sponsor
- University of Manitoba
Adherence to Medication Regime
Early Antiretroviral Therapy and Pre-exposure Prophylaxis for HIV Prevention Among Female Sex Workers in Cotonou, Benin
In the last few years, early treatment of HIV-infected individuals, or "treatment as prevention (TasP), and pre-exposure prophylaxis with antiretroviral drugs among HIV-negative people at very high-risk of acquiring the infection…
- Trial name
- TasP/PrEP (NCT02237027)
- Testing
- TasP using ART regimen as per Benin guidelines, PrEP using Truvada
- Where
- Benin
- Volunteers
- 361 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Pre-exposure Prophylaxis, HIV-1-infection
Peer Outreach and Navigation Intervention to Increase PrEP Uptake Among Women at High Risk for HIV
This pilot study will assess the feasibility and acceptability of a peer outreach and navigation intervention designed to increase access and promote HIV pre-exposure prophylaxis (PrEP) uptake among women at high risk for HIV.
- Trial name
- NCT03226873
- Testing
- Peer Navigation
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
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 Infections
Optimizing Implementation of Long Acting Injectable PrEP
Our goal is to optimize LAI-PrEP implementation within the context of other PrEP methods. Our strategy is flexible to allow pivot to include forthcoming PrEP dosing options should they become available
- Trial name
- NCT07649551
- Testing
- Plan-Do-Study-Act
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
HIV Infections
HIV Pre-exposure Prophylaxis Implementation Hong Kong Study
While pre-exposure prophylaxis (PrEP) is widely recommended and a number of pilot studies are on-going worldwide, progress of its implementation in the real world setting has been slow, especially in Asia.
- Trial name
- NCT04367688
- Testing
- Tenofovir Disoproxil Fumarate 300 mg / emtricitabine 200 mg
- Where
- Hong Kong
- Volunteers
- 339 people, healthy volunteers welcome
- Sponsor
- Chinese University of Hong Kong
Patient Acceptance of Health Care
Acceptability of HIV Oral PrEP Among MSM and TGW
The purpose of this study is to determine the factors associated with acceptability to oral HIV pre-exposure prophylaxis (PrEP) among Thai men who have sex with men (MSM) and transgender women (TGW).
- Trial name
- NCT02855606
- Where
- Thailand
- Volunteers
- 105 people
- Sponsor
- Chiang Mai University
HIV Prevention
Digital Health Feedback System (DHFS) for Longitudinal Monitoring of ARVs Used in HIV Pre-exposure Prophylaxis (PrEP)
This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect information about patients taking their Pre-Exposure…
- Trial name
- NCT03693040
- Testing
- Digital Health Feedback System
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- University of California, San Diego
HIV Infection, Sexual and Reproductive Health
PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-exposure Prophylaxis (PrEP) Option for HIV Prevention. Injectable PrEP Will be Offered Alongside Oral and Vaginal Ring PrEP From Within a Real-world Context in Cape Town, South Africa.
The goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period.
- Trial name
- PtC (NCT06807736)
- Testing
- Cabotegravir long-acting, Tenofovir emtricitabine, Dapivirine containing vaginal ring
- Where
- South Africa
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- Desmond Tutu HIV Foundation
HIV
Advanced HIV Prevention (PrEP Chicago)
This study will evaluate the feasibility of a network intervention to train individuals to disseminate PrEP information and motivate initial PrEP interest and knowledge of PrEP in their social networks.
- Trial name
- NCT02896699
- Testing
- PrEP Intervention Group, Control Group
- Where
- United States
- Volunteers
- 424 people, healthy volunteers welcome
- Sponsor
- University of Chicago
HIV, Pre-exposure Prophylaxis
COVID-19 Infection in Patients Infected With HIV and/or on PrEP
The SARS-CoV-2 epidemic was declared as a global pandemic by the WHO on March 12, 2020. France is affected with approximately 120,000 biologically confirmed cases, as of April 30, 2020, a figure probably very underestimated.
- Trial name
- COVIDHIVPrEP (NCT04379245)
- Testing
- Data research, database analysis
- Where
- France
- Volunteers
- 4,200 people
- Sponsor
- Hospices Civils de Lyon
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
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
Pre-Exposure Prophylaxis of HIV Infection
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
The goal of this clinical study is to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (F/TDF) for prevention of HIV in the cisgender women in…
- Trial name
- PURPOSE 3 (NCT06101329)
- Testing
- Lenacapavir Tablet, Lenacapavir Injection, Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)
- Where
- 11 sites in United States
- Volunteers
- 253 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Overdose Accidental
Naltrexone for Overdose Prevention
The goal of this clinical trial is to see if an injectable medicine called naltrexone can prevent fentanyl overdose deaths in people who use other drugs (cocaine, methamphetamine).
- Trial name
- NOD (NCT06633900)
- Testing
- IM naltrexone, Usual Care
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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/AIDS, Contraception
Pharmacokinetics and Pharmacodynamics of DMPA With HIV PrEP
This study is a biphasic steady state pharmacokinetic and pharmacodynamic study of TFV and FTC in healthy women comparing the drug levels and activity in the absence (first phase) and then the presence (second phase) of DMPA.
- Trial name
- DynamoPrEP (NCT03197961)
- Testing
- tenofovir/emtricitabine, DMPA
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Sharon Achilles
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 Infections
Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT
The goal of this hybrid (1a) Cluster Randomised Controlled Trial phase 3B trial is to evaluate the effectiveness and implementation of offering a choice of HIV Pre-Exposure Products (PrEP) through community-based sexual and…
- Trial name
- LAPIS (NCT06250504)
- Testing
- APRETUDE (cabotegravir) 600 mg\3 mL, DAPIRING (Dapivirine) 25mg Vaginal Ring, tenofovir disoproxil and emtricitabine
- Where
- South Africa
- Volunteers
- 2,052 people, healthy volunteers welcome
- Sponsor
- Africa Health Research Institute