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

mCARES：一项艾滋病毒依从干预措施，旨在支持患有/有吸毒和精神健康障碍风险的少数种族/族裔妇女

• 批准号: 10548483
• 负责人: Lunthita M Duthely
• 金额: $ 22.96万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10548483
• 关键词: Address; Adherence; Affect; Alcohols; American; Appointment; Award; Behavior Therapy; Behavioral; Caring; Clinic; Clinical; Cognitive Therapy; Communication; Cultural Diversity; Data; Development; Diagnosis; Drug usage; Economics; Education; Effectiveness; Epidemic; Ethnic Origin; Evidence based intervention; Face; Feasibility Studies; Future; Goals; HIV; HIV Infections; Haitian; Health; Health Promotion; Health behavior change; Health system; Healthcare; Hybrids; Illicit Drugs; Incidence; Individual; International; Intervention; Interview; Language; Linguistics; Location; Marijuana; Measures; Mediator of activation protein; Mental Depression; Mental Health; Mental disorders; Methods; Minority; Minority Women; Modeling; Multilingualism; National Institute of Drug Abuse; Not Hispanic or Latino; Outcome; Participant; Patients; Persons; Pharmaceutical Preparations; Population; Poverty; Procedures; Process; Protocols documentation; Race; Randomized; Randomized Controlled Trials; Reminder Systems; Research; Research Personnel; Risk; Services; Site; Structure; Substance Use Disorder; System; Testing; Text Messaging; Tobacco; Trauma; United States; United States National Institutes of Health; Viral; Viral Load result; Woman; Work; arm; base; behavior change; coping; design; effective intervention; effectiveness implementation study; effectiveness outcome; empowerment; ethnic minority; evidence base; health disparity; health literacy; high risk; implementation determinants; implementation framework; implementation outcomes; improved; innovation; instrument; intervention effect; literacy; mHealth; medical appointment; motivational enhancement therapy; novel; patient-level barriers; personalized approach; pilot test; pilot trial; problem solving therapy; psychoeducational; racial and ethnic; racism; resilience; response; safety net; scale up; social; social stigma; standard of care; substance use; success; telehealth; therapy design; uptake

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).

项目摘要/摘要 意义：生活在美国的感染艾滋病毒的种族/少数民族妇女面临着大量的心理健康和社会问题 挑战(耻辱、贫困、精神健康诊断、药物使用、有限的健康/英语素养) 影响他们坚持艾滋病毒护理的能力(例如，药物和医疗预约)。此应用程序 解决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：这是一项多语种MCARES的第一类混合有效性/实施试点 (英语、西班牙语、海地-克里奥尔语)移动医疗(MHealth)遵守和参与干预 感染艾滋病毒的种族/少数民族妇女(MWLH)，通过PI的KL2发展。MCARES(移动 遵守通知教育和支持)，使用基于证据的方法 个性化文本消息和患者导航，与激励性访谈相集成，在 多语种、多文化的妇女艾滋病诊所。调查小组在国内和国际上 因设计和实施艾滋病毒行为和移动健康干预措施而获得认可，在 精神健康、创伤、药物使用和种族/族裔妇女。因为短信和患者导航 是以证据为基础的行为改变方法，尽管不是针对特定的高需求的多语言 在本项目中正在研究的人群中，如果成功的话，需要迅速扩大这一第一类试点的规模 混合试验，注重有效性和实施结果。干预设计植根于 医疗保健赋权模型(HCE)，该模型考虑了为个人赋权的多方面影响 从事医疗保健，并统一其他艾滋病毒行为干预模式，包括CBT/LifeSteps 提高遵从性。实施的试行测试将遵循CFIR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 关于语言/文化适应的方法，开展一项公开试点试验(N=9；每种语言3个MWLH)。目标2： 衡量mCARES对患者临床结果的初步有效性；(目标2a)评估可行性， MCARES双臂试点的可接受性和接受度(6个月)。参与者将被随机分组(N=78；每 语言；3种语言；1：1按语言分配)，以接受标准护理或MCARES。(目标2b)评估 意向治疗对服药和预约依从性、转诊跟进和VL抑制的影响； 和，(目标2c)测试概念性调节因素(例如，种族、语言、抑郁、吸毒、恢复能力)、调解人 (例如，艾滋病毒污名、抑郁和个人决定因素(例如，健康素养)的变化)对干预效果的影响。 (目标2d)采取混合方法方法，试行测试mCARES的实施决定因素(例如，患者- 吸收的水平障碍、设计质量)。成功完成AIMS将产生全面的数据 学习。此应用程序响应PA-21-205，为个人开发/测试新的远程保健策略 为受影响人群量身定做的艾滋病毒和药物使用障碍(例如，多语种方法)。