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

项目摘要 大约40%的拉丁美洲男男性接触者感染艾滋病毒没有达到病毒抑制，估计有可能 由于COVID-19疫情的压力因素，如失业，失去医疗保险， 无家可归，以及COVID-19造成的精神健康和物质使用障碍加剧 流行病抗逆转录病毒治疗（ART）依从性与病毒载量降低、CD 4+细胞增加相关 计数，住院天数更少，疾病进展更慢，生存期更长。坚持也有助于防止 耐药性，降低艾滋病毒传播风险。本研究的主要目的是评估 阶梯式护理策略在提高拉丁美洲成年男男性接触者抗逆转录病毒治疗依从性中的有效性 序贯、多重分配、随机试验（SMART）。该试验将比较以下阶梯式护理策略： 首先提供TXTXT，并逐步为无应答者提供远程患者导航，而不是阶梯式护理 首先提供TXTXT +电子导航，然后逐步向EMA支持的电子导航战略， 响应者。TXTXT（“治疗文本”）和电子导航干预措施的基础都是CDC 循证干预（EBI）。我们建议使用智能设计，明确允许建筑， 测试和优化阶梯式护理策略，而不影响严格性或随机性。我们提出了三 具体目标：目标1。比较两种静态治疗的即时（6个月）和持续（9个月和12个月）疗效 （非阶梯式）治疗方案（TXTXT单药vs. TXTXT + e-Navigation）对ART依从性和病毒感染的影响 拉丁裔男男性行为者中艾滋病毒的抑制。目标2.比较即刻（6个月）和持续（9个月和 两种阶梯式护理策略（TXTXT+无应答者与 TXTXT + e-Navigation，为无应答者增加EMA支持）对ART依从性和病毒抑制的影响 拉丁裔男男性接触者中感染艾滋病病毒的人数目标3。确定关联的基线和随时间变化的主持人 拉丁裔男男性接触者中阶梯式护理策略与抗逆转录病毒疗法依从性和病毒抑制之间的关系。的 拟议的研究是创新的文化适应和结合两个EBI，使用分步护理方法， 远程患者导航器、自适应EMA组件和SMART设计。拟议的研究具有重要意义 因为它提供了关于在一个有效设计中两个可扩展EBI的功效的数据， 为无反应者提供更好的治疗选择。这项研究也很重要，因为它针对的是美国国立卫生研究院的健康 差异人口（拉丁美洲男男性接触者），并解决多个领域和对健康和健康的影响水平 差距。它还针对生活在结束艾滋病毒流行地理重点地区的人， 全国（南佛罗里达）艾滋病毒诊断率，从而支持减少艾滋病毒不平等的目标， 高风险人群和生活在美国南部的人群。

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.