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: 10708810
• 负责人: Lunthita M Duthely
• 金额: $ 22.97万
• 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/10708810
• 关键词: Address; Adherence; Affect; Alcohols; American; Appointment; Award; Behavior Therapy; Behavioral; Caring; Clinic; Clinical; Cognitive Therapy; Communication; Data; Development; Diagnosis; Disparity; 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; 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; Problem Solving; 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; behavior change; coping; design; effective intervention; effectiveness outcome; effectiveness/implementation hybrid; empowerment; ethnic minority; evidence base; health disparity; health literacy; high risk; implementation determinants; implementation framework; implementation outcomes; implementation/effectiveness; improved; innovation; instrument; intervention effect; literacy; mHealth; medical appointment; motivational enhancement therapy; novel; patient navigation; patient-level barriers; personalized approach; pilot test; pilot trial; psychoeducation; psychoeducational; racial minority; 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：种族/族裔少数民族妇女在美国的精神健康和社会面临 挑战（污名，贫困，心理健康诊断，药物使用，健康 /英语识字率有限） 影响他们遵守HIB护理的能力（例如，医疗和医疗任命） 解决了迈阿密的少数民族艾滋病毒健康成果的差异，迈阿密是新美国艾滋病毒感染的中心[3]。 研究策略：这是I型杂交剂/MCHER的实施飞行员，这是一种多语言 （英语，西班牙语，身高）移动健康（MHealth）遵守和参与干预措施 艾滋病毒（MWLH）的种族/族裔少数民族妇女开发了PI的KL2。 依从性的沟通提醒教育和支持），采用基于证据的方法 个性化的文本消息传递和患者导航，与动机访谈集成在一起，在 多语言和多元文化女性艾滋病毒诊所。 以设计和实施HIV行为和MHe​​alth的认可 心理健康，创伤，物质使用和种族/种族女性。 是基于证据的行为改变的方法 在本项目中研究的流行音乐，如果成功的话，这是I型飞行员的需求 侧重于有效性和实施结果的混合试验。 医疗保健授权模型（HCE），它考虑了赋予个人权力的多方面影响 从事医疗保健，并统一其他HIV行为干预模型，包括CBT/LIFESTEPS 提高依从性。 迭代实施过程，改进（通过退出访谈）和重新实施以及框架 语言 /文化适应的方法，进行开放的试点试验（n = 9;每语言3 mwlh）。 测量McAres对患者临床结果的初步效果； 2臂的MCAR飞行员的可接受性和吸收（6个月）。 语言; 1：1分配语言） 意图对治疗对药物和任命依从性，推荐后续和VL抑制的影响； 和（AIM 2C）测试概念主持人（例如种族，语言，语言，脱落，毒品使用，弹性），调解人 （例如，艾滋病毒污名，抑郁症和个人决定因素（例如健康素养）对干预效果的变化。 （AIM 2D）采用混合方法方法，进行测试McAres的IIMPLENTIONS确定性（例如，患者 - 摄取的水平障碍，设计的障碍）。 研究。 与艾滋病毒和实质性疾病有关，量身定制为受影响的人群（例如，多语言方法）。