Clinical trials: PrEP Adherence
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-I Infection
Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women
The investigators will conduct an observational cohort study in 1200 pregnant women who will be recruited at the first antenatal care (ANC) visit from the Gugulethu and one additional facility in the Klipfontein-Mitchell's Plain…
- Trial name
- PrEP-PP (NCT03902418)
- Testing
- emtricitabine/tenofovir
- Where
- South Africa
- Volunteers
- 1,195 people
- Sponsor
- University of California, Los Angeles
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
Human Immunodeficiency Virus
Feasibility of Short-Term PrEP Uptake for MSM With Episodic High-Risk for HIV
This study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis (PrEP) for HIV prevention among men who have sex with men (MSM).
- Trial name
- NCT02495779
- Testing
- emtricitabine/tenofovir, CBT-based counseling
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- James Egan
Prevention
Optimizing PrEP Uptake & Adherence Among Male Sex Workers (MSW) Using a 2-stage Randomization Design
"PrEPare for Work" 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 Male Sex Workers (MSW).
- Trial name
- NCT03086057
- Testing
- PrEPare for Work: Strength Based Case Management (Stage 1), PrEPare for Work: Adherence Training and Counseling (Stage 2)
- Where
- 2 sites in United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Brown 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/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
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.
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
ART Adherence, PMTCT
HIV Self Testing of Male Partners of Women in PMTCT
The investigators will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits (HIVST) to HIV-positive pregnant women to provide to their male partner, increases the proportion of male partners who…
- Conditions
- ART Adherence, PMTCT, Linkage to Care, HIV
- Trial name
- NCT03484533
- Testing
- HIV self-test kit, Standard of Care (invitation letters for fast-track HIV testing in the clinic)
- Where
- Uganda
- Volunteers
- 736 people, healthy volunteers welcome
- Sponsor
- University of Washington
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
Colorectal Cancer
Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep
This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade versus Movi Prep for outpatient colonoscopy.
- Trial name
- NCT01695863
- Testing
- comparing 2 drugs on their effect on the bowel preparation for colonoscopy
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center
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
Risk Reduction
Point-of-care Urine Monitoring of Adherence: Testing a Real-Time Urine Assay of Tenofovir in PrEP
Worldwide expansion of pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) will be critical to ending the HIV epidemic.
- Trial name
- PUMA (NCT03935464)
- Testing
- PUMA
- Where
- Kenya
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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
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
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
HIV/AIDS, Adherence, Medication
Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor
Truvada®, an oral pill comprised of two anti-retroviral compounds, emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), is currently the only drug combination approved for pre-exposure prophylaxis (PrEP) in women exposed…
- Conditions
- HIV/AIDS, Adherence, Medication, Drug Use
- Trial name
- NCT04870671
- Testing
- Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC)
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Eastern Virginia Medical School
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/AIDS, Substance Use Disorders
Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
This study deploys a novel digital pill with Emtricitabine/Tenofovir (TDF/FTC) among MSM with substance use to monitor PrEP adherence.
- Conditions
- HIV/AIDS, Substance Use Disorders, Adherence, Medication
- Trial name
- DigiPrEP (NCT03842436)
- Testing
- Digital pill, Truvada
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Brigham and Women's Hospital