Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) Clinical Trial

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07125235
Status
Recruiting
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Conditions

  • ART Adherence
  • Behavioral Intervention
  • Viral Suppression of HIV Infection

Eligibility Criteria

Sex
MALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention — BEHAVIORAL
    The reSTART intervention integrates a mobile health application, a urine tenofovir point-of-care self-test, and adherence feedback with motivational messages to increase HIV medication intake, reduce stimulant use, and improve HIV virologic suppression.
  • urine tenofovir point-of-care self-test — DEVICE
    urine tenofovir point-of-care self-test

Study Details

Men who are living with HIV and use stimulants face many challenges and barriers that may interfere with remembering to take their HIV medication. Forgetting to take HIV medication puts men living with HIV at a greater risk of becoming virally unsuppressed. Researchers are doing this study to test if a remote intervention can help participants improve remembering to take their HIV medications and reduce the HIV viral load among men living with HIV who use stimulants.

Key Dates

Start date
Feb 9, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2028
Completion
Jul 30, 2028

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: reSTART Intervention
    The reSTART intervention will be administered to this group and includes: (1) adherence self-monitoring tools delivered during a single baseline motivational interviewing session; (2) the urine tenofovir point-of-care self-test with adherence feedback and visualizations with motivational messages; (3) a positive affect intervention delivered via a mobile health application which supports stimulant-using men in reducing stimulant use.
  • No Intervention: Standard of Care
    The control group will receive standard of care and will not receive the reSTART intervention.

Primary Outcome Measure

Viral suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR [ Time Frame: Baseline to 6-months post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94110
Matthew Spinelli, MD, MAS
[email protected]
415-806-8554

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By research site
University of California, San Francisco· San Francisco, CA

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