Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) mHealth Randomized Controlled Hybrid Type I Effectiveness Implementation Trial
Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Prescribed antiretroviral therapy (ART) with a tenofovir-based regimen.
• Documented virologic non-suppression, urine tenofovir testing without tenofovir detected, or self-reported adherence \<100%.
• Reports stimulant use.
• Has a mailing address within the U.S.
• Currently has a smartphone with photo capabilities.
Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Shivani Mahuvakar
shivani.mahuvakar@ucsf.edu
415-878-6384
Backup
Kevin Sassaman
Time Frame
Start Date:2026-02-09
Estimated Completion Date:2028-07-30
Participants
Target number of participants:270
Treatments
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.