Clinical trials: Pre-Exposure Prophylaxis (PrEP)
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, Sexually Transmitted Diseases
Mobile-Based Application "MyChoices"
This study is testing the acceptability and feasibility of MyChoices, a mobile application (app), to promote HIV testing and pre-exposure prophylaxis (PrEP) uptake among young men who have sex with men (YMSM).
- Conditions
- HIV, Sexually Transmitted Diseases, Pre-exposure Prophylaxis, Risk Reduction
- Trial name
- NCT03179319
- Testing
- MyChoices
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Fenway Community Health
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States
This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low and high-volume PrEP sites in…
- Trial name
- PILLAR (NCT05374525)
- Testing
- APRETUDE, Cabotegravir OLI
- Where
- 17 sites in United States
- Volunteers
- 287 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Human Immunodeficiency Virus (HIV)
Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis
This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight weeks over a 40 week period among sexually active…
- Trial name
- TMC278LA (NCT02165202)
- Testing
- Rilpivirine
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- PATH
Hiv
Mhealth for PrEP Adherence by Young Adult MSM, Phase 2
This Phase 2 project aims to enhance and test a mobile health intervention designed to increase adherence to the daily PrEP pill among culturally-diverse young adult men who have sex with men.
- Trial name
- NCT04633200
- Testing
- DOT mobile app
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Environment and Health Group, Inc.
Patient Adherence, HIV Seronegativity
CCTG 595: Text Messaging Intervention to Improve Adherence to PrEP in High-risk MSM
CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical demonstration project to determine if the use of a text-message based adherence intervention (iTAB) improves retention and adherence to PrEP compared to…
- Trial name
- NCT01761643
- Testing
- SoC + iTab
- Where
- 4 sites in United States
- Volunteers
- 398 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
HIV/AIDS, Adherence, Medication
Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users
Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine…
- Conditions
- HIV/AIDS, Adherence, Medication, Drug Use
- Trial name
- NCT03584282
- Testing
- Text Messaging, Peer Navigation
- Where
- 2 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Washington
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
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 Infection
Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).
This is a prospective observational cohort sub-study of subjects enrolled in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 (NCT01772823) or ATN 113 (NCT01769456), which is a prospective…
- Trial name
- NCT01769469
- Testing
- FTC/TDF (Truvada®)
- Where
- 12 sites in United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Prevention
Pharmacy Delivery to Expand the Reach of PrEP in Kenya
3 consecutive studies to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.
- Trial name
- NCT04558554
- Testing
- pharmacy-based PrEP delivery
- Where
- 2 sites in Kenya
- Volunteers
- 1,216 people, healthy volunteers welcome
- Sponsor
- University of Washington
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
Virus Diseases, Rabies
A Phase 3 Clinical Trial to Evaluate Long-term Immunogenicity and Boostability of Purified Chick-Embryo Cell Rabies Vaccine in Adults Following Primary Series of Pre/Exposure Prophylaxis.
The aim of this study is to evaluate the long-term (up to approx.10 years) persistence and to assess the boostability of immune responses in participants who received a primary series of accelerated or conventional rabies PrEP IM…
- Trial name
- NCT02545517
- Testing
- Rabipur, Blood sampling, Purified Chick-Embryo Cell Rabies Vaccine
- Where
- 7 sites in Austria, Germany and 1 more
- Volunteers
- 459 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pre-Exposure Prophylaxis, HIV Infections
PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
This study tests strategies for improving PrEP implementation in maternal and child health clinics using a difference-in-difference approach.
- Conditions
- Pre-Exposure Prophylaxis, HIV Infections, Pregnancy Related
- Trial name
- NCT04712994
- Testing
- PrEP Optimization Interventions
- Where
- 8 sites in Kenya
- Volunteers
- 1,958 people, healthy volunteers welcome
- Sponsor
- University of Washington
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, Substance Use Disorders
Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that responds to real-time PrEP adherence and nonadherence detected through the use of a digital pill.
- Trial name
- PrEPSteps (NCT03512418)
- Testing
- PrEPsteps, Digital pill, Truvada
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Brigham and Women's Hospital
PrEP Adherence Monitoring
Pre-Exposure Prophylaxis (PrEP) Adherence Monitoring Using Dried Blood Spots
The primary objective of this study is to define the mean, variance, and dose proportionality for tenofovir-diphosphate(TFV-DP) in dried blood spots resulting from 33%, 67%, and 100% of daily dosing with 200mg emtricitabine and…
- Trial name
- DOT-DBS (NCT02022657)
- Testing
- Truvada
- Where
- 2 sites in United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Depression, Pre-Exposure Prophylaxis
Friendship Bench Mental Health Intervention for Adolescent Girls and Young Women in South African PrEP Delivery Settings
Adolescent girls and young women (AGYW) at risk of HIV in sub-Saharan Africa, frequently (20-50%) have symptoms of common mental disorders, including depression, anxiety, and stress.
- Trial name
- NCT05664490
- Testing
- Youth Friendship Bench SA
- Where
- South Africa
- Volunteers
- 116 people
- Sponsor
- University of California, San Francisco
HIV/AIDS
Standardized Patient Encounters to Improve PrEP Counseling for Adolescent Girls and Young Women in Kenya
The goal of this study is to facilitate uptake of and adherence to HIV pre-exposure prophylaxis (PrEP) among adolescent girls and young women (AGYW) in Kenya.
- Trial name
- PrIYA-SP (NCT03875950)
- Testing
- Clinician training intervention
- Where
- Kenya
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- University of Washington
Pre-Exposure Prophylaxis, Sexually Transmitted Diseases, Bacterial
Alignment of PrEP Use With HIV Risk in Young Women and Men
Oral pre-exposure prophylaxis (PrEP) is a recommended component of combination HIV prevention and its availability is rising through demonstration projects and full-scale national programs.
- Conditions
- Pre-Exposure Prophylaxis, Sexually Transmitted Diseases, Bacterial, HIV Infections
- Trial name
- NCT04664998
- Testing
- Daily oral PrEP
- Where
- Uganda
- Volunteers
- 212 people, healthy volunteers welcome
- Sponsor
- University of Washington