Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention, urine tenofovir point-of-care self-test.
- Who it may be relevant to
- Registry conditions: Behavioral Intervention, Viral Suppression of HIV Infection, ART Adherence. Basic parameters: 18 years — 70 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) mHealth Randomized Controlled Hybrid Type I Effectiveness Implementation Trial
Overview
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.
Interventions
- Behavioral 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. - Device urine tenofovir point-of-care self-test
urine tenofovir point-of-care self-test
Primary outcome measures
- Viral suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR [Time frame: Baseline to 6-months post-intervention]
Secondary outcome measures (3)
- Stimulant Use measured quantitatively by stimulant levels in hair [Time frame: Baseline to 6-months post-intervention]
- Long-term Viral Suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR. [Time frame: Baseline to 12-months post-intervention]
- Adherence to Tenofovir-based antiretroviral therapy [Time frame: Baseline to 6-months post-intervention]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT07125235 · 25-44467 · UH3DA058304