Clinical trials: Pre-exposure Prophylaxis (PrEP) Adherence
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
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
HIV
HPTN 073 Black Men Who Have Sex With Men (MSM) Pre-Exposure Prophylaxis (PrEP)
Black men who have sex with men (MSM) Pre-Exposure Prophylaxis (PrEP) Study with Client Centered Care Coordination (C4) Component.
- Trial name
- NCT01808352
- Testing
- Observational
- Where
- 3 sites in United States
- Volunteers
- 226 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
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
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 Pre-exposure Prophylaxis, HIV Prevention and Care
MyPrEP Plus: Development and Pilot Testing of Novel Preexposure Prophylaxis Decision Support Tools for Transgender Women
The primary goal of this randomized controlled trial is to learn if a decision support tool called MyPrEP Plus can help transgender women make decisions about taking pre-exposure prophylaxis (PrEP) for HIV prevention.
- Conditions
- HIV Pre-exposure Prophylaxis, HIV Prevention and Care, Mobile Health Technology (mHealth), Adherence
- Trial name
- NCT07146139
- Testing
- MyPrEP Plus Package, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
Pre-Exposure Prophylaxis
Developing mHealth to Promote PrEP Use Among Thai Young Vulnerable Adolescents and Emerging Adults
The main aim of this study is to develop technology-based interventions to improve HIV pre-exposure prophylaxis (PrEP) uptake and adherence among Thai young transgender women.
- Trial name
- NCT05262426
- Testing
- Behavioral: Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP), Enhanced YaCool, Standard PrEP Counseling
- Where
- 3 sites in Thailand
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Worcester
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.
HIV
Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.
- Trial name
- NCT02732730
- Testing
- Truvada, Drug level counseling at Weeks 8 and 13
- Where
- 3 sites in South Africa, Zimbabwe
- Volunteers
- 451 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
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
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
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 Infections, Pregnancy Related
mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence During Pregnancy and Breastfeeding
In high HIV prevalence regions, women are at high risk for HIV during pregnancy and breastfeeding. To protect women and reach elimination of mother-to-child HIV transmission, the World Health Organization recommends offering oral…
- Conditions
- HIV Infections, Pregnancy Related, Adherence, Medication
- Trial name
- NCT04472884
- Testing
- mWACh-PrEP, Standard of Care
- Where
- 4 sites in Kenya
- Volunteers
- 600 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
HIV/AIDS
Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis for Adoption and Adherence for Black Canadians
Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of African, Caribbean and Black (ACB) Canadian patients Aim 2.
- Trial name
- PrEPDSA (NCT03637244)
- Testing
- Decision Support Aid and PrEP for Black Canadians
- Where
- Canada
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
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
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
Human Immunodeficiency Virus (HIV)
Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
This study identifies social and behavioral factors likely to influence PrEP acceptability and adherence among men who have sex with men (MSM), and collaborates with a community health center to evaluate a two-stage intervention…
- Trial name
- SPARK (NCT02037594)
- Testing
- Sexual Health Counseling, Enhanced Adherence Intervention, PrEP Information (Active Control)
- Where
- United States
- Volunteers
- 438 people, healthy volunteers welcome
- Sponsor
- Hunter College of City University of New York
HIV Prevention, Pre-exposure Prophylaxis
Stick2PrEP Cisgender Women and Trans Individuals
Taking a daily anti-HIV pill can protect people from HIV infection. This is called preexposure prophylaxis [PrEP]. Many cisgender women and trans individuals do not know this medication is available; others struggle to take the…
- Trial name
- S2P:CWTI (NCT05165745)
- Testing
- Individualized Feedback
- Where
- United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Columbia University
HIV
IPREP Study #2: Evaluating Enhanced PrEP Packages for Young Female Sex Workers in Kisumu, Kenya
This is an open-label randomized controlled trial (n=200) in which HIV-negative young female sex workers (FSW) will be randomized to receive oral PrEP combined with specific behavioral and structural adherence interventions…
- Trial name
- NCT03988387
- Testing
- Peer Support (PS), Reminder and Resource Transfer (RRT), daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]
- Where
- Kenya
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Columbia University