Actively Recruiting
Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) mHealth Randomized Controlled Trial to Improve HIV Viral Suppression and Reduce Stimulant Use in Men
Led by University of California, San Francisco · Updated on 2026-03-13
270
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
F
Florida International University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Men living with HIV who use stimulants often face difficulties remembering to take their HIV medications, which can increase their risk of having an unsuppressed viral load. This research aims to test a remote, multi-component intervention called reSTART to help improve medication adherence and reduce stimulant use among this group. The study is a randomized clinical trial investigating how this approach may support better HIV viral suppression and stimulant use outcomes. The reSTART intervention combines several tools including a home-based urine tenofovir point-of-care self-test for adherence monitoring, motivational interviewing sessions, motivational messages, and a positive affect mobile health application designed to support men in reducing stimulant use. Participants in the intervention group will receive these components, while the control group will receive standard care without the reSTART tools. The study will evaluate the intervention's impact during and after the treatment period. Participants will be men aged 18 to 70 years who are prescribed tenofovir-based antiretroviral therapy and report stimulant use. They will be monitored for viral suppression using HIV-1 RNA tests and stimulant use measured by hair sample analysis over a period of up to 12 months post-intervention. Adherence will also be assessed through urine testing and self-report. The study includes remote and home-based testing, motivational support, and mobile app usage, with safety and adherence tracked throughout the study duration.
CONDITIONS
Brief Title
Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 to 70 years
- Prescribed antiretroviral therapy (ART) with a tenofovir-based regimen
- Documented virologic non-suppression, no tenofovir detected on urine testing, or self-reported adherence less than 100%
- Reports stimulant use
- Has a mailing address within the U.S.
- Currently owns a smartphone with photo capabilities
You will not qualify if you...
- Any health condition that may interfere with participation or ability to provide informed consent, including debilitating or life-threatening conditions
- Not prescribed ART
- Unwilling to perform urine self-testing or attend a local site for viral load monitoring
- Unable to provide a hair sample of approximately 50-100 strands that are non-gray, not bleached, and at least 1cm in length
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive the reSTART intervention, which includes adherence self-monitoring tools, a urine tenofovir point-of-care self-test with adherence feedback and motivational messages, and a positive affect mobile health application to support medication adherence and reduce stimulant use. Participants in the control group receive standard care without these interventions.
1 baseline visit and regular follow-up visits during the intervention period
Duration - Up to 12 months post-intervention
Participants are monitored to assess long-term viral suppression and adherence after completing the intervention.
Periodic follow-up visits after intervention completion
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94110
Actively Recruiting
Research Team
S
Shivani Mahuvakar
K
Kevin Sassaman
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here