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

Not Applicable

Not yet recruiting

• Conditions: Behavioral Intervention; Viral Suppression of HIV Infection; ART Adherence

• Registration Number: NCT07125235
• Lead Sponsor: University of California, San Francisco

Brief 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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-01
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-19
• Study Start: 2025-10-01
• Primary Completion: 2028-04-30
• Study Completion: 2028-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 270

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 <90%.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Viral suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR	Baseline to 6-months post-intervention	The primary endpoint will be change in viral suppression comparing baseline to post-intervention viral load results measured by HIV-1 RNA, Quantitative, Real-Time PCR. Viral suppression is defined as viral load results that yield less than 200 copies/mL.

Secondary Outcome Measures

Name	Time	Method
Stimulant Use measured quantitatively by stimulant levels in hair	Baseline to 6-months post-intervention	Stimulant levels will be compared pre- and post-intervention and measured quantitatively using liquid chromatography-mass spectrometry laboratory techniques.
Adherence to Tenofovir-based antiretroviral therapy	Baseline to 6-months post-intervention	Urine tenofovir levels measured by the urine tenofovir point-of-care self-test lateral flow assay at baseline and 6-months post-intervention will be compared to assess the presence or absence of tenofovir and changes in adherence to HIV medications.
Long-term Viral Suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR.	Baseline to 12-months post-intervention	As a secondary endpoint, long-term viral suppression will be measured at 12-months and compared to baseline viral load results from HIV-1 RNA, Quantitative, Real-Time PCR. Viral suppression is defined as viral load results that yield less than 200 copies/mL.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States