Clinical trials: PrEP Adherence
Risk Reduction
PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men
Despite advances in HIV prevention, the HIV incidence among young men who have sex with men (YMSM) is increasing, threatening to derail achievement of the United States End the HIV Epidemic goals.
- Trial name
- PrEP2-BAY (NCT05353283)
- Testing
- Motivational Interviewing Counselling, Point-of-care Urine Tenofovir Measurement
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV Infections, Contraception
A Crossover Acceptability Study Assessing a DPP Capsule for HIV and Pregnancy Prevention
The study design is a single-site, two-arm, randomized, open-label crossover trial in 30 AGYW aged 16-24 in Chitungwiza (Harare), Zimbabwe.
- Trial name
- 952 (NCT04778514)
- Testing
- Dual Prevention Pill, PrEP and combined oral contraceptive (COC) as two separate tablets
- Where
- Zimbabwe
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Population Council
PrEP, PrEP Adherence Monitoring
Prevention ICONA Dedicated Ensemble
Despite significant advances in HIV treatment, transmission remains a public health concern. In 2022, there were 1.3 million new HIV infections worldwide and 1,888 new diagnoses in Italy, with sexual transmission being the…
- Conditions
- PrEP, PrEP Adherence Monitoring, HIV, HIV -1 Infection
- Trial name
- PrIDE (NCT07186244)
- Where
- 53 sites in Italy
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Fondazione ICONA
PrEP Adherence, Sexually Transmitted Infections (STIs)
STI Testing to Enhance PrEP Use in Pregnancy
The investigators are conducting a study in Botswana to see if offering STI testing along with expanded HIV prevention options (PrEP) helps more pregnant women start and continue using PrEP during and after pregnancy.
- Conditions
- PrEP Adherence, Sexually Transmitted Infections (STIs), Pregnancy
- Trial name
- STEP-UP (NCT06919614)
- Testing
- Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing
- Where
- Botswana
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Botswana Harvard AIDS Institute Partnership
HIV
Enhancing PrEP in Community Settings (EPIC)
To test the effectiveness of Prepmate, a novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support among young men who have sex with men (MSM).
- Trial name
- NCT02371525
- Testing
- Prepmate
- Where
- United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Patient Adherence, HIV Seronegativity
Randomized Controlled Trial of iTAB Plus Motivational Interviewing for PrEP Adherence in Transgender Individuals
CCTG 603 is an open-label, two-arm, randomized (1:1) clinical demonstration project to determine if brief Motivational Interviewing (MI-B) added to a text-message based adherence intervention (iTAB) improves adherence to PrEP…
- Trial name
- NCT03086200
- Testing
- brief Motivational Interviewing
- Where
- 5 sites in United States
- Volunteers
- 263 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Adherence, Medication, HIV Prevention
Pharmacy-based PrEP for Young Women Who Sell Sex in Zimbabwe
Pharmacy-based PrEP for Young Women who Sell Sex in Zimbabwe is a cluster-randomized control trial and pilot study co-led by Dr.
- Trial name
- TOPAZ (NCT06348069)
- Testing
- Pharmacy-based PrEP refill and gift voucher, Control (Standard of care)
- Where
- Zimbabwe
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of California, Berkeley
HIV/AIDS
The PrEP (Pre-exposure Prophylaxis) SMART Study
The PrEP SMART study is testing a stepped model of scalable adherence support strategies in South African young women who initiate PrEP using a SMART (sequential multiple assignment randomized trial) design.
- Trial name
- NCT04038060
- Testing
- WhatsApp Group, 2-way SMS, Drug level feedback
- Where
- South Africa
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- University of Washington
Prevention
Adaptive Intervention to Facilitate PrEP Uptake/Adherence Among Transgender Women
"PrEP N' Shine" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Transgender women (TGW).
- Trial name
- NCT05016232
- Testing
- PrEP N' Shine: Strength Based Case Management (Stage 1), PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2)
- Where
- United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Medication Adherence, HIV Prevention
PrEP Affect Regulation Treatment Innovation
This multi-site randomized controlled trial enrolling sexual minority men who use stimulants and are currently taking pre-exposure prophylaxis (PrEP).
- Conditions
- Medication Adherence, HIV Prevention, Stimulant Use
- Trial name
- PARTI (NCT04899024)
- Testing
- PARTI, Attention-Control, Contingency Management for PrEP Adherence
- Where
- 2 sites in United States
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Florida International University
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
Adherence, Medication
Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care
The purpose of this study is to test how different types of interventions may affect how someone takes their pre-exposure prophylaxis (PrEP) medication.
- Trial name
- NCT04316715
- Testing
- Lifesteps for PrEP, Daily text message reminders
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of Miami
Drug Use Disorders, PrEP Uptake
Reducing Co-occurring Substance Use and HIV Risk Among Stimulant-using Men at High Risk for HIV in the United States of America.
This intervention will focus on stimulant-using men at high risk for HIV who are in need of tailored behavioral interventions to mitigate co-occurring stimulant use and HIV risk in the era of pre-exposure prophylaxis (PrEP).
- Conditions
- Drug Use Disorders, PrEP Uptake, PrEP Adherence, HIV Risk Behavior
- Trial name
- NCT07281378
- Testing
- Tailored Positive Affect Intervention, Contingency Management
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- University of Florida
Adherence, Medication, Smartphone Application
Effectiveness of Smartphone Application for Adherence Support (Vuka+)
This is a Type I Hybrid effectiveness-implementation trial to evaluate an HIV Pre-Exposure Prophylaxis (PrEP) medication adherence, persistence and social support app (Vuka+) for adolescent girls and young women (AGYW) in South…
- Trial name
- NCT06897059
- Testing
- Vuka+ application
- Where
- South Africa
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Eastern Virginia Medical School
HIV/AIDS, HIV Infections
Harm Reduction Program For Informal PrEP Users In A Community-based Setting (seguiPrEP)
Pre-Exposure Prophylaxis (PrEP) is a biomedical strategy consisting of the use of antiretroviral therapy by HIV-seronegative people at high risk of acquiring HIV, to prevent the infection.
- Conditions
- HIV/AIDS, HIV Infections, Sexually Transmitted Diseases, Vaccination
- Trial name
- seguiPrEP (NCT03996941)
- Testing
- Harm reduction of informal PrEP use, PrEP follow up based on point of care testing
- Where
- Spain
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- BCN Checkpoint
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
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
Improving Uptake and Adherence to HIV Prevention Services With Pre-exposure Prophylaxis (PrEP), HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda
The main aim is to develop and assess an intervention to enhance initiation and adherence to PrEP among HIV negative young women of high risk (YWHR).
- Trial name
- POPPi (NCT04030520)
- Testing
- POPPi, Comparison
- Where
- Uganda
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV Prevention, HIV Risk
Evaluating an Interactive Digital Toolkit for Women's PrEP Implementation
The goal of this study is to test if a Digital PrEP Toolkit helps cisgender women learn about and access PrEP in Alabama and Mississippi. PrEP is a medication that prevents HIV infection.
- Conditions
- HIV Prevention, HIV Risk, Sexual and Reproductive Health
- Trial name
- NCT07292584
- Testing
- Interactive Digital PrEP Toolkit
- Where
- 4 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Adherence, Medication, Risk Reduction
Prevention and Risk: Treatment With a New Emphasis on Relationships
This research examines the efficacy of an individually-delivered intervention tailored for YMSM in relationships. The intervention - termed PARTNER - utilizes a brief (4 session) motivational interviewing format to target…
- Conditions
- Adherence, Medication, Risk Reduction, Drug Use, Sex, Anal
- Trial name
- PARTNER (NCT03396367)
- Testing
- PARTNER, Education Intervention
- Where
- United States
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Hunter College of City University of New York