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

Официальное название

Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) mHealth Randomized Controlled Hybrid Type I Effectiveness Implementation Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Устройство urine tenofovir point-of-care self-test
  urine tenofovir point-of-care self-test

Первичные конечные точки

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

Вторичные конечные точки (3)

• Stimulant Use measured quantitatively by stimulant levels in hair [Срок оценки: Baseline to 6-months post-intervention]
• Long-term Viral Suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR. [Срок оценки: Baseline to 12-months post-intervention]
• Adherence to Tenofovir-based antiretroviral therapy [Срок оценки: Baseline to 6-months post-intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT07125235 · 25-44467 · UH3DA058304

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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