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

支持抽象 尽管几十年来关于改善艾滋病毒和酒精管理的行为干预措施的研究 新兴成年人(18-29岁)危险行为的高比率，只有一种干预措施 在全面试验中显示可改善艾滋病毒携带者的病毒负担和酒精使用 足够严谨，可以在JAMA期刊上发表。健康的选择，经过调整和发展量身定做 为初出茅庐的成年人解决自我管理的危险行为和艾滋病毒的动机增强 治疗，在SAMHSA的循证项目登记中的一个简短的酒精干预。我们现在将进行 一种混合型1比较有效性-实施试验以开发适应性干预(一种 剂量和递送格式可以定制)。第一个随机比较现有的简短的mHealth MI- 基于自我管理的干预(Thrive)与简短的mHealth和单一的远程健康会议 选择。我们通过使用智能设计(顺序多次)超越了传统的临床试验 分配随机试验)作为一种高效而严谨的方式来探索要优化的其他问题 干预措施并最大限度地实现现实世界的实施，例如：1)是否需要额外的兴旺 在YPLWH中报告一次后遵守80%且没有NIAA定义的危险饮酒的人进行检查 1个月(响应者)；2)YPLWH报告&lt；=80%的遵从性和1个月的危险饮酒 随访(无应答者)哪个更有效更经济，剩下的三个疗程健康 选择通过远程医疗与移动医疗提供。作为另一项创新，我们包括行为、生物标记物 和务实的成果。我们计划在佛罗里达州范围内招募300名报告任何 酗酒和≤80%坚持接受抗逆转录病毒治疗(来自诊所、社区组织和 社交媒体)，并在基线、3个月、6个月和12个月收集数据。项目支持的目标是优化 健康选择推进旨在改善自我管理的适应性和可持续干预 在了解全州范围内实施和维持的背景的同时，在青少年儿童医院开展酒精和艾滋病毒活动 一种高效实施的类型1混合智能。主要目的是比较Thrive，一种移动健康 以酒精和艾滋病毒自我管理为目标的干预措施，Thrive加上一个远程保健 健康选择会议。我们可以在一次会议中建立酒精和艾滋病毒管理的动力，但 不涉及自我管理技能的范围。因此，我们也致力于了解其余部分的好处 为无响应者举行的三次健康选择会议，以比较这些会议的交付效果 通过远程健康或mHealth，并确定mHealth助推器对应答者的好处。最后，我们准备 通过研究障碍和来自多个利益相关者的推动者，使用 建立我们适用于青少年预防和治疗级联的执行模式(EPIS) 并将健康经济因素包括在内。

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.