Research Project
10290733
PROJECT SUMMARY Despite efforts to achieve UNAIDS 95-95-95 targets, marked deficits remain in antiretroviral therapy (ART) adherence and viral suppression among persons living with HIV (PLWH). Gaps in HIV treatment success are particularly pronounced in racial and ethnic minority populations and particularly among Latinos in the Northeast United States (US) and the Caribbean. Progression of HIV disease and premature deaths among PLWH have been attributed foremost to insufficient engagement in medical care and adherence to HIV treatment regimens. Timely access to ART and subsequent sustained ART adherence are central to therapeutic success and critical determinants of long-term health outcomes (e.g., viral suppression) in PLWH. To that end, our team conducted extensive formative work (CDC:U01PS003715) with racial/ethnic minority PLWH and their providers to identify the content, features, functionalities, and interface of a mobile app to improve health outcomes, including ART adherence. Building on the findings, the Agency for Healthcare Research and Quality (AHRQ) provided support to build this app and integrate it with a smart pill box (CleverCap) enabling PLWH to self-monitor their medication adherence in real-time. This innovative tool, the WiseApp, supersedes current approaches to ART adherence using a self-management mobile app linked to an electronic pill box and is currently being evaluated in a randomized controlled trial (RCT) (NCT03205982) in New York City (NYC). At the same time, there is a strong need for the development and testing of self-management interventions for Spanish speaking Latino PLWH since they are the largest and fastest growing ethnic minority group in the US and are disproportionately affected by HIV. We propose to test the transferability of the WiseApp to Latinos in the US and the Dominican Republic (DR) by translating and culturally adapting it and conducting a multi-site RCT to assess its efficacy. The proposed project is aligned with AHRQ Special Emphasis Notice NOT-HS-16-015 and will use health information technology to facilitate the collection and use of patient-reported outcomes including medication adherence, quality of life, and symptom burden. The study will address the following specific aims: 1. Adapt and ensure the usability of the WiseApp for Spanish speaking PLWH. 2. Conduct a RCT to assess the efficacy and sustainability of the WiseApp compared to a usual care control in a transnational sample of Spanish speaking PLWH at 3, 6, and 12 months. 3. Identify multi-level barriers and facilitators to the widespread implementation of the WiseApp. A mixed-methods, multi-stakeholder process evaluation of the WiseApp will be conducted guided by the Consolidated Framework for Implementation Research. The proposed project builds on our team's robust preliminary data and capitalizes on the strong linkage between Columbia University and Clínica de Familia in the DR. This project's significance is further enhanced by capitalizing on the strong presence of Latinos in the Washington Heights neighborhood of NYC, the disproportionately high rates of HIV in the DR, and the patterns of geographic mobility between NYC and the DR. Importantly, our study focuses on AHRQ Priority Populations, specifically chronically ill, inner-city, low-income, and racial/ethnic minority persons.
