NCT07125235

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

Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) mHealth Randomized Controlled Hybrid Type I Effectiveness Implementation Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A resurgent stimulant epidemic among men living with HIV could compromise the U.S. Ending the HIV Epidemic goals by interfering with HIV care engagement, adherence, and virologic suppression among men living with HIV. Prominent multi-level factors interfere with HIV virologic suppression for men living with HIV, particularly among those who use stimulants. This study is a nested randomized clinical trial to test a multi-component intervention to improve virologic suppression, adherence, and stimulant use among men living with HIV who use stimulants. The intervention, known as reSTART, will combine an evidence-based positive affect mobile health (mHealth) intervention, a home-based urine point-of-care test for adherence self-monitoring, and motivational interviewing and messages. The goal of the reSTART intervention is to improve or maintain adherence to HIV medications and reduce stimulant use. By this high-impact study's end, the investigators will have identified the impact of a multi-component reSTART mHealth intervention using novel point-of-care adherence self-monitoring on HIV virologic suppression and stimulant use.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention	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.
DEVICE	urine tenofovir point-of-care self-test	urine tenofovir point-of-care self-test

Timeline

• Start date: 2026-02-09
• Primary completion: 2028-04-30
• Completion: 2028-07-30
• First posted: 2025-08-15
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study