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NCT Number: NCT07125235

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

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.

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Key information

Conditions

Behavioral Intervention ART Adherence Viral Suppression of HIV Infection

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94110, United States

Location status: Recruiting

Location contact

Matthew Spinelli, MD, MAS

CONTACT

[email protected]

415-806-8554

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention

Behavioral

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.

Other names: Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART)

urine tenofovir point-of-care self-test

Device

urine tenofovir point-of-care self-test

Primary outcomes

  1. Viral suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR

    Time frame: 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 50 copies/mL.

Secondary outcomes

  1. Stimulant Use measured quantitatively by stimulant levels in hair

    Time frame: 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.

  2. Long-term Viral Suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR.

    Time frame: 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 50 copies/mL.

  3. Adherence to Tenofovir-based antiretroviral therapy

    Time frame: 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.

Other outcomes

  1. Acceptability of the Intervention using the Theoretical Framework of Acceptability Questionnaire

    Time frame: Enrollment to 6-months post-intervention

    The acceptability of the intervention will be measured using the Theoretical Framework of Acceptability Questionnaire. Questions will be framed using Likert scales where a score of 1 corresponds to completely unacceptable and a score of 5 corresponds to completely acceptable.

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Sassaman

CONTACT

Shivani Mahuvakar

CONTACT

[email protected]

415-878-6384

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Florida International University
  • National Institute on Drug Abuse (NIDA)
  • San Diego State University

Registry information

Official study title

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

Acronym: reSTART

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 15, 2025
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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