Reactive Driven Support for Treatment, Adherence, Resilience, and Thriving (reSTART) mHealth Randomized Controlled Hybrid Type I Effectiveness Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Viral suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: reSTART Objective Adherence Self-Monitoring and Postive Affect mHealth Intervention (Behavioral)
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.
干预措施: urine tenofovir point-of-care self-test (Device)
Standard of Care
The control group will receive standard of care and will not receive the reSTART intervention.
结局指标
主要结局
Viral suppression measured by HIV-1 RNA, Quantitative, Real-Time PCR
时间窗: Baseline to 6-months post-intervention
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.
次要结局
- 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)