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

mHealth e-Navigator 分级护理干预对拉丁裔 MSM 中 ART 依从性的效果

基本信息

批准号：
10538818
负责人：
Diana Montserrat Sheehan
金额：
$ 51.43万
依托单位：
FLORIDA INTERNATIONAL UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-07-13 至 2027-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10538818
关键词：
Address Adherence Adult Advocacy Area Belief CD4 Lymphocyte Count COVID-19 pandemic Caring Case Management Centers for Disease Control and Prevention (U.S.)Client Clinical Treatment Data Disease Progression Drug resistance Ecological momentary assessment Epidemic Evidence based intervention Florida Foundations Geography HIV HIV diagnosis Health Insurance Health Services Accessibility Health education Homelessness Individual Informal Social Control Interpersonal Relations Intervention Latino Latino Population Length of Stay Life Mental Health Outcome Patients Persons Population Randomized Randomized Controlled Trials Relationship-Building Reporting Risk Sampling Self Efficacy Self Management Sequential Multiple Assignment Randomized Trial Social Work Substance Use Disorder Testing Text Time Treatment Protocols Trust Unemployment United States United States National Institutes of Health Viral Viral Load result antiretroviral therapy arm base care coordination cost effectiveness design efficacy evaluation forgetting health disparity health disparity populations high risk improved improved outcome innovation mHealth men men who have sex with men pill post intervention prevent programs psychosocial social cognitive theory stressor success therapy adherence transmission process treatment adherence trial design two way texting

项目摘要

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.

项目概要大约 40% 感染 HIV 的拉丁裔 MSM 没有实现病毒抑制——这一估计可能由于失业、失去健康保险等 COVID-19 大流行压力因素而加剧 COVID-19 导致无家可归以及加剧的心理健康和药物滥用障碍抗逆转录病毒治疗 (ART) 依从性与病毒载量降低、CD4 增加相关。坚持也有助于预防耐药性并降低 HIV 传播风险本研究的主要目的是评估阶梯式护理策略的有效性，以提高成年拉丁裔 MSM 感染 HIV 的 ART 依从性序贯、多重分配、随机试验 (SMART) 该试验将比较阶梯式护理策略。首先提供 TXTXT，然后针对无反应的患者进行远程患者导航与分级护理首先提供 TXTXT + 电子导航并逐步向非 EMA 支持的电子导航的策略 TXTXT（“治疗文本”）和电子导航干预措施的基础都是 CDC。我们建议使用基于证据的干预措施（EBI），明确允许构建、在不影响严谨性或随机性的情况下，我们提出了三个测试和优化阶梯护理策略。具体目标：目标 1. 比较两种静态疗法的即时（6 个月）和持续（9 和 12 个月）疗效（非阶梯式）治疗方案（单独 TXTTT 与 TXTXT + 电子导航）对 ART 依从性和病毒的影响目标 2. 比较立即（6 个月）和持续（9 个月）和持续（9 个月）。两种阶梯式护理策略（TXXT，针对无应答者添加电子导航与针对无应答者添加电子导航）的效果（12 个月） TXTXT + 电子导航，增加了对无反应者的 EMA 支持）关于 ART 依从性和病毒抑制目标 3. 确定关联的基线和随时间变化的调节因素。感染 HIV 的拉丁裔 MSM 的阶梯式护理策略与 ART 依从性和病毒抑制之间的关系。拟议的研究是创新的，通过文化适应和结合两个 EBI，使用阶梯式护理方法，远程患者导航器、自适应 EMA 组件和 SMART 设计这项研究意义重大。因为它提供了有关一种高效设计中两种可扩展 EBI 的功效的数据，并提供了有关以下方面的数据：这项研究也很重要，因为它针对的是 NIH 健康。人口差异（拉丁裔男男性行为者），并解决对健康和健康的多个领域和水平的影响它还针对生活在结束艾滋病毒流行地理重点地区的人们。全国（南佛罗里达州）的艾滋病毒诊断率，从而支持减少艾滋病毒差距的目标居住在美国南部的高危人群。