Efficacy of an mHealth + e-Navigator stepped care intervention for ART adherence among Latino MSM

项目总结 大约40%的携带艾滋病毒的拉丁裔MSM没有实现病毒抑制--这一估计很可能 由于失业、失去医疗保险等新冠肺炎大流行压力因素而恶化， 无家可归，加剧了新冠肺炎造成的心理健康和药物使用障碍 大流行。抗逆转录病毒治疗(ART)的依从性与病毒载量的降低、CD4的升高有关 更少的住院天数、更慢的疾病进展和更长的存活期。坚持也有助于防止 抗药性，降低艾滋病毒传播风险。这项研究的主要目标是评估 采用分级护理策略改善成年拉丁裔MSM感染HIV患者抗逆转录病毒治疗依从性的效果 序贯、多重分配、随机试验(SMART)。该试验将比较循序渐进的护理策略 首先提供TXTXT，并为无应答者提供远程患者导航，而不是分步护理 优先交付TXTXT+电子导航，并逐步向EMA支持的非 响应者。TXTXT(“治疗文本”)和电子导航干预的基础都是疾控中心 循证干预(EBI)。我们建议使用一种智能设计，明确允许建筑， 在不影响严格性或随机性的情况下测试和优化阶梯式护理策略。我们提出三个建议 具体目标：目标1.比较两种静止剂的即刻(6个月)和持续(9个月和12个月)疗效 ART黏附和病毒感染的(非阶梯式)治疗方案(TXT单独治疗与TXTXT+e导航治疗比较) 在感染艾滋病毒的拉丁裔男男性接触者中进行压制。目标2.比较即刻(6个月)和持续(9个月和 12个月)两种阶梯式护理策略的有效性(TXT，为无应答者增加了电子导航与 TXTXT+电子导航，增加了对非应答者的EMA支持)关于ART坚持和病毒抑制 在感染艾滋病毒的拉丁裔男男性接触者中。目标3.确定关联的基线和随时间变化的主持人 在感染艾滋病毒的拉丁裔MSM中，阶梯式护理策略与抗逆转录病毒治疗的依从性和病毒抑制之间的关系。这个 拟议的研究是创新的，通过在文化上适应和结合两个EBI，使用分步护理方法， 远程患者导航器、自适应EMA组件和智能设计。这项拟议的研究具有重要意义 因为它在一个有效的设计中提供了关于两个可扩展EBI的有效性的数据，并提供了 增强了对无应答者的治疗选择。这项研究也很有意义，因为它针对的是NIH的健康 差异人口(拉丁裔MSM)，解决对健康和健康的多个领域和水平的影响 差距。它还针对生活在结束艾滋病毒流行的地理重点地区的人 全国(南佛罗里达州)艾滋病毒诊断率，从而支持减少艾滋病毒差距的目标 生活在美国南部的高危人群。

PROJECT SUMMARY Approximately 40% of Latino MSM with HIV do not achieve viral suppression—an estimate that has likely worsened due to COVID-19 Pandemic stressors such as unemployment, loss of health insurance, homelessness, and exacerbated mental health and substance use disorders caused by the COVID-19 pandemic. Antiretroviral therapy (ART) adherence is associated with decreased viral load, increased CD4 counts, fewer hospital days, slower disease progression, and longer survival. Adherence also helps prevent drug resistance and reduces HIV transmission risk. The primary objective of this study is to evaluate the efficacy of stepped care strategies to improve ART adherence among adult Latino MSM with HIV using a sequential, multiple assignment, randomized trial (SMART). The trial will compare a stepped care strategy of delivering TXTXT first and stepping up to remote patient navigation for non-responders vs. a stepped care strategy of delivering TXTXT + e-Navigation first and stepping up to EMA-supported e-Navigation for non- responders. Both, TXTXT (“Treatment Text”) and the foundations of the e-Navigation interventions are CDC evidence-based interventions (EBI). We propose to use a SMART design which explicitly allows building, testing, and optimizing stepped care strategies without compromising rigor or randomization. We propose three specific aims: Aim 1. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two static (non-stepped) treatment regimens (TXTXT alone vs. TXTXT + e-Navigation) on ART adherence and viral suppression among Latino MSM with HIV. Aim 2. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two stepped care strategies (TXTXT with added e-Navigation for non-responders vs. TXTXT + e-Navigation with added EMA support for non-responders) on ART adherence and viral suppression among Latino MSM with HIV. Aim 3. Identify baseline and time-varying moderators on the association between stepped care strategy and ART adherence and viral suppression among Latino MSM with HIV. The proposed study is innovative by culturally adapting and combining two EBIs, using a stepped care approach, remote patient navigators, adaptive EMA components, and a SMART design. The proposed study is significant because it provides data on the efficacy of two scalable EBIs in one efficient design and provides data on enhanced treatment options for non-responders. The study is also significant because it targets an NIH health disparity population (Latino MSM) and addresses multiple domains and levels of influence on health and health disparities. It also targets people living in an Ending the HIV Epidemic geographic focus area with the highest HIV diagnosis rate in the nation (South Florida), thereby supporting the objectives of reducing HIV disparities in populations at high risk and living in the Southern US.