reSTART: remote support to help men with HIV take their medication and reduce stimulant use
Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) mHealth Randomized Controlled Hybrid Type I Effectiveness Implementation Trial
This trial will test whether a remote program of positive messages, motivational support, and a home urine tenofovir self-test can help men with HIV who use stimulants remember their HIV medicines and lower their viral load.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Male |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07125235 on ClinicalTrials.gov |
What this trial studies
This nested randomized trial enrolls men living with HIV who report stimulant use and have evidence of non-adherence or viral non-suppression. Participants are randomized to receive the multi-component reSTART intervention — a positive-affect mobile health program with motivational messages, home point-of-care urine tenofovir self-testing for adherence monitoring, and brief motivational interviewing — or usual care. The intervention is delivered remotely with mailed test kits and app-based communications, and viral load outcomes are confirmed through local laboratory testing. The primary aims are to improve or maintain ART adherence, increase rates of viral suppression, and reduce stimulant use.
Who should consider this trial
Good fit: Men living with HIV who use stimulants, are prescribed a tenofovir-based ART regimen, have evidence of non-adherence or non-suppression, have a U.S. mailing address, and own a smartphone with a camera are the intended participants.
Not a fit: People not on a tenofovir-based ART, unwilling or unable to perform home urine testing or provide required hair samples, lacking a U.S. mailing address or smartphone, or with health conditions preventing informed consent are unlikely to benefit.
Why it matters
Potential benefit: If effective, the intervention could help participants improve adherence and achieve viral suppression through remote support and real-time self-monitoring.
How similar studies have performed: Prior mHealth and adherence self-monitoring studies have shown promise for improving ART adherence, but combining positive-affect messaging with home tenofovir point-of-care testing and motivational interviewing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Have any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions. * Not prescribed ART. * Unwilling to perform urine self-testing or to attend a local Quest site for viral load monitoring. * Unable to provide a hair sample of \~50-100 strands of hair that are non-gray, not bleached, and at least 1cm in length
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Matthew Spinelli, MD, MAS — University of California, San Francisco
- Study coordinator: Shivani Mahuvakar
- Email: shivani.mahuvakar@ucsf.edu
- Phone: 415-878-6384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.