Clinical trials: Pre-exposure Prophylaxis
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
STI, Sexually Transmitted Diseases
Assessing the Feasibility and Preliminary Impact of a mHealth App on Reducing STI Risk in Black MSM PrEP Users
The study will recruit 120 Black men who have sex with men (BMSM) from the local area, New Orleans. The main purpose of this research study is to test the effect of a new smartphone application, "PCheck," on reducing the…
- Conditions
- STI, Sexually Transmitted Diseases, Pre-exposure Prophylaxis
- Trial name
- NCT05395754
- Testing
- App Intervention
- Where
- 2 sites in United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans
HIV
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.
A prospective, open, multicenter,demonstrative of PrEP, which aims to assess the acceptability, feasibility and safety from chemoprophylaxis co-formulated emtricitabine / tenofovir disoproxil fumarate (FTC / TDF) administered…
- Trial name
- PrEPBrasil (NCT01989611)
- Testing
- emtricitabine / tenofovir 200/300 mg
- Where
- 3 sites in Brazil
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Oswaldo Cruz Foundation
HIV Infections
Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand
The primary goals of this study are to assess the safety and efficacy of daily tenofovir to prevent parenteral HIV infection among injection drug users (IDUs).
- Trial name
- NCT00119106
- Testing
- Tenofovir disoproxil
- Where
- Thailand
- Volunteers
- 2,413 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
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
Human Immunodeficiency Virus (HIV)
ComBaCaL HIV Prevention TwiCs
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for…
- Trial name
- CoPrev (NCT07581600)
- Testing
- CoPrev model, Referral to the nearest responsible health facility
- Where
- 2 sites in Lesotho, Switzerland
- Volunteers
- healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Hiv
Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM
The proposed project involves the development and testing of an mhealth intervention to increase adherence to PrEP treatment using texts providing tailored pill reminders, motivational messages, and health education messages.
- Trial name
- NCT04233931
- Testing
- PrEP medication adherence mobile app
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Environment and Health Group, Inc.
HIV, Human Immunodeficiency Virus
PRe-Exposure Prophylaxis Acceptability & Readiness Assessments for Toronto gaY, Bisexual and Other Men Who Have Sex With Men-5
Canada continues to see an unrelenting stream of new HIV diagnoses, with a disproportionate burden among gay, bisexual, and other MSM in major centers such as Toronto.
- Trial name
- PREP-5 (NCT02149888)
- Testing
- Tenofovir/emtricitabine
- Where
- Canada
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
Gonorrhea, Chlamydia
Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men
The purpose of this study is to understand if taking an antibiotic called doxycycline by mouth as soon as possible after sexual contact without a condom can reduce the risk of sexually transmitted infections (STIs), including…
- Conditions
- Gonorrhea, Chlamydia, Syphilis
- Trial name
- NCT03980223
- Testing
- Doxycycline Hyclate Delayed-Release 200 mg
- Where
- 3 sites in United States
- Volunteers
- 641 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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/AIDS
The CHAPS Trial: Combined HIV Adolescent PrEP and Prevention
To compare the effect of different PrEP drugs (FTC-TDF and FTC-TAF), doses and timing of doses on p24 antigen level in resected foreskin tissue following HIV exposure ex vivo challenge.
- Trial name
- CHAPS (NCT03986970)
- Testing
- Tenofovir
- Where
- South Africa
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Wits Health Consortium (Pty) Ltd
Human Immunodeficiency Virus (HIV), HIV Pre-exposure Prophylaxis
HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics
This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.
- Trial name
- HTS PrEP (NCT07089966)
- Testing
- HTS counselor-led PrEP care model
- Where
- Kenya
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- University of Washington
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, Infertility
Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples
Human immunodeficiency virus (HIV) infection has now become a treatable disease and many infected individuals are interested in having a family.
- Trial name
- PrEP-HIVD (NCT02572505)
- Testing
- Truvada
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Missouri-Columbia
HIV Infections, Sexual Behavior
HIV and STIs Clinical Study in Germany
The BRAHMS study is a prospective observational cohort study aiming to investigate how often people that are at risk to get infected with HIV contract HIV and how long people stay in the study.
- Conditions
- HIV Infections, Sexual Behavior, Risk Reduction
- Trial name
- NCT03884816
- Testing
- Determine the Incidence and Retention Rate
- Where
- 10 sites in Germany
- Volunteers
- 1,017 people, healthy volunteers welcome
- Sponsor
- Hendrik Streeck
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
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
GonoScreen: Efficacy of Screening STIs in MSM
A Multicentre, controlled, randomized trial of 3 site (urethra, pharynx and rectum) sampling performed every 3 months (3x3) for Neisseria gonorrhoea (Ng)/Chlamydia trachomatis (Ct) screening (comparator) vs.
- Trial name
- GonoScreen (NCT04269434)
- Testing
- No Screening
- Where
- 5 sites in Belgium
- Volunteers
- 1,014 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
HIV Infections
A Systems Analysis and Improvement Approach for Optimizing HIV Service Delivery in Syringe Services Programs
The goal of this clinical trial is to assess the effectiveness of an evidence-based, organizational-level implementation strategy, the Systems Analysis and Improvement Approach, in improving HIV service delivery (SAIA-SSP-HIV) in…
- Trial name
- SAIA-SSP-HIV (NCT06025435)
- Testing
- SAIA-HIV-SSP
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Adherence, Medication, Risk Behavior
DOT Diary Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men
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
- NCT03771638
- Testing
- Emtricitabine / Tenofovir Disoproxil Oral Tablet, DOT Diary mobile app
- Where
- 2 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
Human Immunodeficiency Virus
Biomarkers for Event-driven PrEP Adherence
This study aims to recruit 40 participants who will take the combination anti-HIV drug tenofovir+emtricitabine (TDF/FTC) at specified times.
- Trial name
- NCT04298697
- Testing
- Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Emory University