reSTART: remote support to help men with HIV take their medication and reduce stimulant use
Official title: Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) mHealth Randomized Controlled Hybrid Type I Effectiveness Implementation Trial
Run by University of California, San Francisco · NCT07125235 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Men only |
| Enrollment | 270 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Status | Recruiting |
| Started | February 9, 2026 |
| Main results expected | April 30, 2028 |
| Study ends | July 30, 2028 |
| Registry record updated | March 13, 2026 |
| Trial ID | NCT07125235 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Baduanjin exercise for improving health in sedentary adults
A 12-week Baduanjin exercise program is being tested to see if it can improve fitness, body composition, strength, balance, flexibility, and daily sitting time in sedentary adults aged 18–59.
-
Nurse follow-up nudge to reduce emergency visits after ambulatory-sensitive diagnoses
This project will test whether a nurse follow-up message or phone call after a clinic visit can reduce emergency department visits among adults (30+) diagnosed with ambulatory sensitive conditions.
-
Helping pregnant people manage ADHD symptoms during pregnancy and after birth
This trial will test a behavioral program called MomMA to help pregnant people with ADHD manage their symptoms during pregnancy and after the baby is born.
-
Using a point-of-care urine tenofovir test to improve HIV treatment adherence and viral suppression
This will test whether giving adults with HIV who are not yet virally suppressed a quick urine test showing recent tenofovir use, plus targeted counseling, helps them reach viral suppression in clinics in the Eastern Cape, South Africa.
-
Improving HIV treatment adherence in Latino men who have sex with men
This study is trying to see if using text messages alone or with extra support can help Latino men who have sex with men stick to their HIV treatment better over a year.
-
Evaluating the effectiveness of a new HIV treatment based on patient adherence
This study is testing a new HIV treatment to see how well it works for people who stick to their medication schedule and how it affects their overall health over two years.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.