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

NCT07125235 | Recruiting FDA Device

• 2 other identifiers: 25-44467UH3DA058304
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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

ART Adherence; Viral Suppression of HIV Infection; Behavioral Intervention

Keywords

HIV; Stimulant Use; mHealth

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline to 6-months post-intervention

Secondary Outcomes (3)

• Stimulant Use measured quantitatively by stimulant levels in hair

  Baseline to 6-months post-intervention

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

  Baseline to 12-months post-intervention

• Adherence to Tenofovir-based antiretroviral therapy

  Baseline to 6-months post-intervention

Other Outcomes (1)

• Acceptability of the Intervention using the Theoretical Framework of Acceptability Questionnaire

  Enrollment to 6-months post-intervention

Study Arms (2)

reSTART Intervention

EXPERIMENTAL

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.

Behavioral: reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention; Device: urine tenofovir point-of-care self-test

Standard of Care

NO INTERVENTION

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

Interventions

urine tenofovir point-of-care self-test DEVICE

urine tenofovir point-of-care self-test

reSTART Intervention

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.

Also known as: Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART)

reSTART Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida International University: collaborator
• San Diego State University: collaborator
• University of California, San Francisco: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

RECRUITING

MeSH Terms

Interventions

Therapeutics

Study Officials

• Matthew Spinelli, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shivani Mahuvakar

CONTACT

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

Kevin Sassaman

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled Hybrid Type I Effectiveness Implementation Study

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 15, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)