SMARTer Healthy Choices: Optimizing a state-wide scalable intervention to improve alcohol and HIV self-management in adolescents and emerging adults (Project SUSTAIN)

更明智的健康选择：优化全州范围内的可扩展干预措施，以改善青少年和新兴成年人的酒精和艾滋病毒自我管理（项目 SUSTAIN）

• 批准号: 10678992
• 负责人: SYLVIE NAAR
• 金额: $ 12.96万
• 依托单位: FLORIDA STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-10 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10678992
• 关键词: Address; Adherence; Adolescent; Adolescent Medicine Trials Network; Age; Alcohol consumption; Alcohols; Behavior Therapy; Behavioral; Behavioral Sciences; Biological Markers; Clinic; Clinical Trials; Cognitive; Communities; Cost Effectiveness Analysis; Data; Development; Dose; Economic Factors; Effectiveness; Electronic Health Record; Ensure; Ethnic Origin; Evidence based program; Florida; Gender; Goals; HIV; Health; Home; Hybrids; Intervention; Interview; Journals; Mental Depression; Mental Health; Methods; Modeling; Motivation; National Institute on Alcohol Abuse and Alcoholism; Outcome; Persons; Prevention; Professional counselor; Publishing; Randomized; Registries; Reporting; Research; Risk Behaviors; Sampling; Self Management; Sequential Multiple Assignment Randomized Trial; Translating; United States Substance Abuse and Mental Health Services Administration; Unsafe Sex; Viral Load result; Youth; adaptive intervention; alcohol measurement; antiretroviral therapy; biological sex; brief alcohol intervention; checkup examination; community organizations; comparative cost effectiveness; comparative effectiveness; compare effectiveness; design; effectiveness/implementation trial; emerging adult; follow-up; hazardous drinking; health economics; implementation facilitators; implementation/effectiveness; improved; innovation; intervention delivery; intervention effect; mHealth; marijuana use; medication compliance; motivational enhancement therapy; normative feedback; outreach; peer; primary outcome; programs; recruit; satisfaction; scale up; skills; social media; standard care; substance use; success; telehealth; therapy design; transgender; web-based intervention

SUSTAIN ABSTRACT Despite decades of research on behavioral interventions to improve management of HIV and alcohol and on the high rates of risk behaviors in emerging adults (ages 18-29), there is only one intervention that has been shown to improve viral burden and alcohol use in young people living with HIV (YPLWH) in full-scale trials with sufficient rigor to be published in JAMA journals. Healthy Choices, was adapted and developmentally tailored for emerging adults to address self-management of risk behaviors and HIV from Motivational Enhancement Therapy, a brief alcohol intervention in SAMHSA’s registry of evidenced-based programs. We will now conduct a hybrid Type 1 comparative effectiveness-implementation trial to develop an adaptive intervention (one where dose and delivery format can be tailored). The first randomization compares an existing brief mHealth MI- based self-management intervention (THRIVE) versus brief mHealth plus a single telehealth session of Health Choices. We move beyond a traditional clinical trial by utilizing a SMART design (Sequential Multiple Assignment Randomized Trial) as an efficient and rigorous way to explore additional questions to optimize interventions and maximize real-world implementation such as: 1) is there a need for an additional THRIVE check-up among YPLWH who report >80% adherence AND no NIAA-defined hazardous drinking after one month (responders); and 2) for YPLWH who report <=80% adherence AND hazardous drinking at 1-month follow-up (non-responders) which is more effective and economical, the remaining three sessions of Healthy Choices are delivered via telehealth versus mHealth. As another innovation, we include behavioral, biomarker and pragmatic outcomes. We plan to recruit a diverse sample of 300 YPLWH across Florida who report any alcohol use and ≤80 percent adherence to antiretroviral treatment (from clinics, community organizations, and social media) and collect data at baseline, 3, 6, and 12 months. The goal of PROJECT SUSTAIN is to optimize Healthy Choices to advance an adaptive and sustainable intervention designed to improve self-management of alcohol and HIV in YPLWH while understanding the context for state-wide implementation and sustainment in an effectiveness-implementation Type 1 Hybrid SMART. The primary aim is to compare THRIVE, an mHealth intervention adapted to target self-management of alcohol and HIV, with THRIVE plus a single telehealth session of Healthy Choices. In a single session we can build motivation for alcohol and HIV management but not address the range of self-management skills. Thus, we also aim to understand the benefit of the remaining three Healthy Choices sessions for non-responders, to compare the effectiveness of delivery of these sessions by telehealth or mHealth, and to determine the benefit of mHealth boosters for responders. Finally, we prepare for state-wide implementation by studying barriers and facilitators from multiple stakeholders using an established implementation model (EPIS) that we adapted for the youth prevention and treatment cascades and to include health economic factors.

维持摘要 尽管研究了数十年的行为干预措施，以改善艾滋病毒和酒精的管理 新兴成年人的风险行为率很高（18-29岁），只有一种干预措施 在全尺度试验中，证明可以改善艾滋病毒（yplwh）年轻人的病毒燃烧和饮酒 足够的严格性可以在JAMA期刊上发表。健康的选择，适应并量身定制 供新兴成年人解决风险行为的自我管理和艾滋病毒的自我管理 治疗，对SAMHSA的基于证据的计划的注册表进行了简短的酒精干预。我们现在将进行 一项杂交1型比较有效性实施试验以开发自适应干预措施（其中一项 剂量和递送格式可以量身定制）。第一个随机化比较了现有的简短MHealth mi- 基于自我管理干预（繁荣）与简短的MHealth以及单一的远程医疗课程 选择。我们通过使用智能设计（顺序多重）超越了传统的临床试验 任务随机试验）是一种探索其他问题以优化的有效而严格的方法 干预措施并最大化现实世界实施，例如：1）是否需要额外的繁荣 在报告> 80％依从性的YPLWH中，没有NIAA定义的危险饮酒。 月（响应者）； 2）对于报告<= 80％的依从性和1个月危险饮酒的YPLWH 后续（非反应者）更有效，更经济，其余三个健康的会议 选择是通过远程医疗与MHealth提供的。作为另一个创新，我们包括行为，生物标志物 和务实的结果。我们计划在佛罗里达州招募300码的潜水员样本，他们报告了任何 饮酒和≤80％的抗逆转录病毒治疗（来自诊所，社区组织和 社交媒体）并在基线，3、6和12个月收集数据。项目维持的目标是优化 健康的选择，以提高适应性和可持续的干预措施，旨在提高自我管理 YPLWH中的酒精和艾滋病毒，同时了解全州范围内实施和维持的背景 有效性实施1型混合动力智能。主要目的是比较蓬勃发展，一个mhealth 干预措施适合针对酒精和艾滋病毒的自我管理，蓬勃发展和单个远程医疗 健康选择会议。在一次会议中，我们可以建立酒精和艾滋病毒管理的动力，但是 无法解决自我管理技能的范围。这也是我们还旨在了解其余的好处 针对非响应者的三个健康选择，以比较交付这些会话的有效性 通过远程医疗或MHealth，并确定MHealth助推器对响应者的好处。最后，我们准备 通过研究来自多个利益相关者的障碍和促进者，使用 我们适应青年预防和治疗级联的既定实施模型（EPIS） 并包括健康经济因素。