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

University of California San Francisco (UCSF)

Status: Not yet enrolling

Conditions: Viral Suppression of HIV Infection; ART Adherence; Behavioral Intervention

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07125235

UH3DA058304 (U.S. NIH Grant/Contract)

25-44467

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 estimated patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

reSTART Intervention

Experimental group

Description:

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.

Treatment:

Device: urine tenofovir point-of-care self-test

Behavioral: reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention

Standard of Care

No Intervention group

Description:

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