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

NCT ID: NCT07125235

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2028-07-30

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.

Conditions

Behavioral Intervention; Viral Suppression of HIV Infection; ART Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention

Intervention Type: 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.

urine tenofovir point-of-care self-test

Intervention Type: DEVICE

urine tenofovir point-of-care self-test

Standard of Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

urine tenofovir point-of-care self-test

urine tenofovir point-of-care self-test

Intervention Type: DEVICE

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Florida International University

OTHER

Sponsor Role: collaborator

San Diego State University

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Spinelli, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Central Contacts

Shivani Mahuvakar

Role: CONTACT

shivani.mahuvakar@ucsf.edu

415-878-6384

Kevin Sassaman

Role: CONTACT

Facility Contacts

Matthew Spinelli, MD, MAS

Role: primary

matthew.spinelli@ucsf.edu

415-806-8554

Other Identifiers

UH3DA058304

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25-44467

Identifier Type: -

Identifier Source: org_study_id