Clinical trials: Pre-Exposure Prophylaxis
HIV Infections
Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities
The purpose of this study is to determine the ability of new anti-HIV agents to penetrate different body compartments in HIV negative men who have sex with men and transgender women.
- Trial name
- NCT02985996
- Testing
- Truvada, Genvoya
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Emory University
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)
COVID-19, SARS-CoV-2
Study Will Assess the Safety, Neutralizing Activity and Efficacy of AZD3152 in Adults With Conditions Increasing Risk of Inadequate Protective Immune Response After Vaccination and Thus Are at High Risk of Developing Severe COVID-19
AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.
- Trial name
- NOVELLA (NCT06057064)
- Testing
- Biological: AZD3152
- Where
- 6 sites in Russia
- Volunteers
- 116 people
- Sponsor
- AstraZeneca
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
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/AIDS, Adherence
Monitoring Pre-exposure Prophylaxis for Young Adult Women
Next generation real-time monitoring for PrEP adherence in young Kenyan women
- Trial name
- MPYA (NCT02915367)
- Testing
- SMS Reminders
- Where
- 2 sites in Kenya
- Volunteers
- 348 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
HIV Prevention
Pre-Exposure Prophylaxis for Transgender Women in the US and South America
A study to assess the feasibility, acceptability, and preliminary impact of a multi-component strategy to improve pre-exposure prophylaxis (PrEP) uptake and adherence that integrates delivery of biomedical HIV prevention…
- Trial name
- NCT04742491
- Testing
- Immediate Intervention Arm, Deferred Intervention Arm
- Where
- 5 sites in United States, Brazil
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
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.
Pre-Exposure Prophylaxis of HIV-1 Infection
Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or…
- Trial name
- DISCOVER (NCT02842086)
- Testing
- F/TAF, F/TDF
- Where
- 93 sites in United States, Austria and 9 more
- Volunteers
- 5,399 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Patient Adherence
Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM
CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs. standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection (ClinicalTrials.gov Identifier: NCT01761643).
- Trial name
- CCTG595VitD (NCT02367599)
- Testing
- Vitamin D Supplement
- Where
- 3 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
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/AIDS, Pre-exposure Prophylaxis
Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK
Our proposed study will: provide a novel exploration of facilitators and barriers to PrEP; allow us to target hard to reach populations, including men who have sex with men (MSM) and substance users (both of which are top funding…
- Trial name
- NCT04064567
- Testing
- PrEP-LINK, Enhanced Standard of Care
- Where
- 7 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Arkansas
HIV Infections
Storytelling to Increase Family Support for Pre Exposure Prophylaxis Use
Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV infection but requires high levels of medication adherence, particularly among women.
- Trial name
- PrEP (NCT04071470)
- Testing
- Storytelling, PrEP
- Where
- Mozambique
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Pre-exposure Prophylaxis
Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System
The premise for the study is that a tailored approach for rural young men who have sex with men (YMSM), addressing known barriers of transportation, access to providers, and privacy, is most likely to yield high levels of…
- Trial name
- ePrEP (NCT03729570)
- Testing
- ePrEP
- Where
- 4 sites in United States
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Emory University
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 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
PrEP Adherence Monitoring
IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project
The overall aim of this study is to assess attitudes toward PrEP, feasibility of Truvada PrEP procurement through the established access procedures, and adherence to Truvada PrEP among US women at risk for HIV acquisition.
- Trial name
- NCT03058835
- Testing
- tenofovir disoproxil and emtricitabine
- Where
- 4 sites in United States
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- Rutgers, The State University of New Jersey