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.

可持续发展摘要 尽管数十年来对行为干预进行了研究，以改善艾滋病毒和酒精的管理， 新兴成年人（18-29岁）的高风险行为率，只有一种干预措施， 在全面试验中显示， 在JAMA期刊上发表。健康的选择，是适应和发展定制 为新兴的成年人解决自我管理的风险行为和艾滋病毒从动机增强 治疗，SAMHSA循证计划注册表中的简短酒精干预。我们现在将进行 混合型1比较有效性-实施试验，以开发适应性干预措施（其中 剂量和递送形式可以定制）。第一次随机化比较了现有的简短mHealth MI- 基于自我管理的干预（THRIVE）与简短的移动健康加上一个单一的远程健康会议的健康 选择.我们超越了传统的临床试验，利用SMART设计（序贯多重 分配随机试验）作为一种有效和严格的方式来探索额外的问题，以优化 干预和最大限度地实现现实世界的实施，如：1）是否需要额外的繁荣 在YPLWH中进行检查，他们报告>80%的依从性，并且在一次检查后没有NIAA定义的危险饮酒 月（应答者）;和2）对于YPLWH，在1个月时报告依从性<=80%和危险饮酒 随访（无应答者），这是更有效和经济，其余三个会议的健康 选择是通过远程保健还是移动保健提供的。作为另一项创新，我们将行为生物标志物 务实的成果。我们计划在佛罗里达招募300名YPLWH， 酒精使用和≤ 80%的抗逆转录病毒治疗依从性（来自诊所，社区组织， 社交媒体），并在基线、3个月、6个月和12个月收集数据。PROJECT SUSTAIN的目标是优化 健康的选择，以促进适应性和可持续的干预，旨在改善自我管理， 酒精和艾滋病毒在YPLWH，同时了解在全州范围内实施和维持的背景下， 一种有效实施类型1混合智能。主要目的是比较THRIVE，一种移动健康 干预调整为目标的自我管理酒精和艾滋病毒，与繁荣加上一个单一的远程保健 健康的选择。在一次会议上，我们可以建立酒精和艾滋病毒管理的动机， 不涉及自我管理技能的范围。因此，我们也希望了解其余的好处， 为无应答者举办三次健康选择会议，以比较这些会议的有效性 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， 建立了实施模型（EPIS），我们对该模型进行了调整，以适应青少年预防和治疗级联 并纳入卫生经济因素。