RecruitingNot ApplicableNCT07125235

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


Sponsor

University of California, San Francisco

Enrollment

270 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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

Interventions

BEHAVIORALreSTART 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.

DEVICEurine tenofovir point-of-care self-test

urine tenofovir point-of-care self-test


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT07125235


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