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: 10304695
• 负责人: SYLVIE NAAR
• 金额: $ 20.4万
• 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/10304695
• 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; Prevention; Professional counselor; Publishing; Randomized; Registries; Reporting; Research; Risk Behaviors; Sampling; Self Management; Sequential Multiple Assignment Randomized Trial; Supervision; Translating; United States Substance Abuse and Mental Health Services Administration; Unsafe Sex; Viral Load result; Youth; adaptive intervention; alcohol measurement; antiretroviral therapy; base; 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; improved; innovation; intervention effect; mHealth; marijuana use; medication compliance; motivational enhancement therapy; normative feedback; outreach; peer; primary outcome; programs; recruit; satisfaction; scale up; skills; social media; 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.

维持抽象 尽管对改善艾滋病毒和酒精管理的行为干预措施进行了数十年的研究， 由于新兴成年人（18-29 岁）的危险行为发生率很高，因此只有一项干预措施得到实施 全面试验显示，可改善年轻艾滋病毒感染者 (YPLWH) 的病毒负担和饮酒情况 足够严格，可以在 JAMA 期刊上发表。健康选择，经过调整和发展定制 帮助新兴成年人通过增强动机来解决危险行为和艾滋病毒的自我管理问题 治疗，是 SAMHSA 登记的循证项目中的一项简短的酒精干预措施。我们现在将进行 一项混合 1 型比较有效性实施试验，以制定适应性干预措施（其中 剂量和给药方式可以定制）。第一次随机化比较了现有的简短 mHealth MI- 基于自我管理干预 (THRIVE) 与简短的移动医疗加一次健康远程医疗会议的比较 选择。我们利用 SMART 设计（序贯多重试验）超越了传统的临床试验 分配随机试验）作为探索其他问题以优化的有效而严格的方法 干预措施并最大限度地在现实世界中实施，例如：1) 是否需要额外的 THRIVE 对 YPLWH 进行检查，报告遵守率 >80%，并且在一次检查后没有 NIAA 定义的危险饮酒 月（应答者）； 2) 对于报告 1 个月内遵守率 <=80% 且有害饮酒的 YPLWH 后续（无反应者）哪个更有效、更经济，其余三期健康 选择是通过远程医疗与移动医疗提供的。作为另一项创新，我们包括行为、生物标志物 和务实成果。我们计划在佛罗里达州招募 300 名 YPLWH 的不同样本，由他们报告任何情况 饮酒以及 ≤80% 的抗逆转录病毒治疗依从性（来自诊所、社区组织和 社交媒体）并收集基线、3、6 和 12 个月的数据。 PROJECT SUSTAIN 的目标是优化 健康选择推进适应性和可持续干预措施，旨在改善自我管理 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 有效性实施类型 1 混合 SMART。主要目的是比较 THRIVE（移动医疗） 通过 THRIVE 和单一远程医疗进行针对酒精和艾滋病毒自我管理的干预措施 健康选择会议。在一次会议中，我们可以激发酒精和艾滋病毒管理的动力，但是 不涉及自我管理技能的范围。因此，我们还旨在了解剩余的好处 为无反应者提供三场“健康选择”课程，以比较这些课程的实施效果 通过远程医疗或移动医疗，并确定移动医疗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因素，在全州范围内实施 建立了适用于青少年预防和治疗级联的实施模型 (EPIS) 并纳入健康经济因素。