mCARES: An HIV Adherence Intervention to Support Racial/Ethnic Minority Women with/at-risk of Substance Use and Mental Health Disorders

项目总结/摘要 重要性：居住在美国的种族/少数民族女性艾滋病毒感染者面临着众多的心理健康和社会问题。 挑战（耻辱，贫困，心理健康诊断，药物使用，有限的健康/英语识字）， 影响他们坚持艾滋病毒护理的能力（例如，药物和医疗预约）。本申请 解决了迈阿密少数民族艾滋病毒健康结果的差异，迈阿密是美国艾滋病毒新感染的中心[3]。 研究策略：这是mCARES的I型混合有效性/实施试点，mCARES是一种多语言 （英语、西班牙语、海地-克里奥尔语）移动的健康（mHealth）依从性和参与干预， 少数种族/族裔妇女艾滋病毒感染者（MWLH），通过PI的KL 2制定。mCARES（移动的 遵守沟通提醒教育和支持），使用基于证据的方法， 个性化的文本消息和患者导航，与动机性访谈相结合，在一个 多语言和多文化的妇女艾滋病诊所。调查小组在国内和国际上 在以下背景下，设计和实施艾滋病毒行为和移动健康干预措施， 精神健康、创伤、药物使用和种族/族裔妇女。因为短信和病人导航 是行为改变的循证方法，尽管不是针对特定的高需求多语言 在本项目所研究的人口中，如果成功，需要迅速扩大第一类试点 混合试验侧重于有效性和实施结果。干预设计基于 医疗保健授权模型（HCE），考虑了赋予个人权力的多方面影响 参与医疗保健，并统一其他艾滋病毒行为干预模式，包括CBT/LifeSteps， 改善粘附性。执行工作的试点测试将遵循《框架》框架。目标1：使用ADAPT-ITT 实施、改进（通过离职面谈）和重新实施的迭代过程，以及框架 语言/文化适应的方法，进行开放性试点试验（N=9;每种语言3 MWLH）。目标二： 测量mCARES对患者临床结局的初步有效性;（目标2a）评估可行性， mCARES（6个月）2组试验的可接受性和吸收。受试者将被随机分组（N=78; 26/ 语言; 3种语言;按语言1：1分配）接受标准护理或mCARES。(Aim 2b）评估 意向治疗对药物和预约依从性、转诊随访和VL抑制的影响; 和，（目标2c）测试概念主持人（例如，种族、语言、抑郁症、药物使用、恢复力）、调解人 (e.g.艾滋病毒污名化、抑郁和个人决定因素的变化（例如，健康知识）对干预效果的影响。 (Aim 2d）采用混合方法，对mCARES的实施决定因素进行试点测试（例如，耐心的 水平障碍，设计质量）。成功完成这些目标将产生全面的数据， study.该应用程序是响应PA-21-205，开发/测试新的远程医疗战略的个人 艾滋病毒和药物使用障碍，适合受影响的人群（例如，多语言方法）。

Project Summary/Abstract Significance: Racial/ethnic minority women with HIV living in the US face a multitude of mental health and social challenges (stigma, poverty, mental health diagnoses, substance use, limited health / English literacy) that impact their ability to adhere to HIV care (e.g., medications and medical appointments). This application addresses disparities in minority HIV health outcomes in Miami, an epicenter of new US HIV infections [3]. Research Strategy: This is a Type I hybrid effectiveness/implementation pilot of mCARES, a multi-lingual (English, Spanish, Haitian-Creole) mobile health (mHealth) adherence and engagement intervention for racial/ethnic minority women living with HIV (MWLH), developed through the PI’s KL2. mCARES (mobile Communications for Adherence Reminders Education and Support), uses evidenced-based approaches of personalized text messaging and patient navigation, integrated with motivational interviewing, implemented in a multi-lingual and multi-cultural Women’s HIV Clinic. The investigative team is nationally and internationally recognized for designing and implementing HIV-behavioral and mHealth interventions, within the context of mental health, trauma, substance use and racial/ethnic women. Because text messaging and patient navigation are evidence-based approaches to behavior change, though not for the specific high-need multi-lingual populations under study in the present project, there is a need for rapid scale up if successful, of this Type I pilot hybrid trial focusing on both effectiveness and implementation outcomes. Intervention design is grounded in the healthcare empowerment model (HCE), which considers the multifaceted influences that empower individuals to engage in healthcare, and unifies other HIV behavioral intervention models, including CBT/LifeSteps to improve adherence. Pilot-testing of implementation will follow the CFIR framework. Aim 1: Using ADAPT-ITT’s iterative process of implementation, refinement (via exit interviews) and re-implementation, and the FRAME approach for linguistic / cultural adaptation, conduct an open pilot trial (N=9; 3 MWLH per language). Aim 2: Measure mCARES’ preliminary effectiveness on patient clinical outcomes; (Aim 2a) Assess feasibility, acceptability and uptake of a 2-arm, pilot of mCARES (6 months). Participants will be randomized (N=78; 26 per language; 3 languages; 1:1 allocation by language) to receive standard of care or mCARES. (Aim 2b) Assess intent-to-treat effects on medication and appointment adherence, referral follow-through, and VL suppression; and, (Aim 2c) test conceptual moderators (e.g., ethnicity, language, depression, drug use, resilience), mediators (e.g. change in HIV stigma, depression, and individual determinants (e.g., health literacy) on intervention effects. (Aim 2d) Taking a mixed-methods approach, pilot-test mCARES’ implementation determinants (e.g., patient- level barriers to uptake, design quality). Successful completion of the aims will generate data for a full-scale study. This application is in response to PA-21-205, to develop / test novel telehealth strategies for individuals with HIV and substance use disorders, tailored to affected populations (e.g., multilingual approaches).