Recruiting

Remote Intervention

Sponsor:

UCLA

Code:

NCT07125235

Conditions

Behavioral Intervention

Viral Suppression of HIV Infection

ART Adherence

Eligibility Criteria

Sex: Male

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention

urine tenofovir point-of-care self-test

Study Details

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.

Conditions

Behavioral Intervention

Viral Suppression of HIV Infection

ART Adherence

Study ID

NCT07125235

Start date

Feb 9, 2026

Status verified date

Mar, 2026

Completion date

Jul 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: reSTART Intervention

The reSTART intervention will be administered to this group and includes: (1) adherence self-monitoring tools delivered during a single baseline motivational interviewing session; (2) the urine tenofovir point-of-care self-test with adherence feedback and visualizations with motivational messages; (3) a positive affect intervention delivered via a mobile health application which supports stimulant-using men in reducing stimulant use.

no intervention: Standard of Care

The control group will receive standard of care and will not receive the reSTART intervention.

Interventions

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.

urine tenofovir point-of-care self-test

urine tenofovir point-of-care self-test

Primary outcome measure

  • Viral suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR [ Time Frame: Baseline to 6-months post-intervention ]

Central Contacts and Locations

Central contacts

Shivani Mahuvakar

415-878-6384shivani.mahuvakar@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94110

Contacts

Matthew Spinelli, MD, MAS

415-806-8554matthew.spinelli@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

  • HIV
  • Stimulant Use
  • mHealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-03-13.