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

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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).