Dissemination of the WiseApp for Improving Health Outcomes Across Settings

项目摘要 尽管为实现艾滋病规划署1995 - 1995 - 1995年的目标作出了努力，但在坚持抗逆转录病毒疗法方面仍然存在明显不足 以及艾滋病毒感染者（PLWH）的病毒抑制。艾滋病毒治疗成功方面的差距尤其 在美国东北部（美国）的少数种族和族裔人口中尤其是拉丁裔中明显 和加勒比艾滋病毒感染者的病情恶化和过早死亡主要归因于 对医疗保健和坚持艾滋病毒治疗方案的参与不足。及时获得抗逆转录病毒治疗， 持续的ART依从性是治疗成功的核心和长期健康结果的关键决定因素（例如， 病毒抑制）。为此，我们的团队进行了广泛的形成性工作（CDC：U 01 PS 003715）， 种族/少数民族PLWH及其供应商，以确定移动的的内容，特点，功能和界面 应用程序来改善健康结果，包括ART依从性。基于这些发现，医疗保健研究机构 和质量（AHRQ）提供了支持，以建立这个应用程序，并将其与智能药盒（CleverCap）集成，使PLWH 实时自我监测他们的药物依从性。这一创新工具WiseApp取代了当前的方法 使用链接到电子药盒的自我管理移动的应用程序， 一项在纽约市（NYC）进行的随机对照试验（RCT）（NCT 03205982）。与此同时， 为讲西班牙语的拉丁裔艾滋病毒携带者制定和测试自我管理干预措施，因为他们是 美国最大和增长最快的少数族裔群体，受艾滋病毒影响不成比例。我们建议 测试WiseApp在美国和多米尼加共和国（DR）的拉丁美洲人的可转移性， 文化适应它，并进行多地点随机对照试验，以评估其疗效。拟议项目与AHRQ保持一致 特别强调通知NOT-HS-16-015，并将利用卫生信息技术促进收集和使用 患者报告的结果，包括药物依从性，生活质量和症状负担。该研究将探讨 具体目标如下：1.调整并确保WiseApp适用于讲西班牙语的艾滋病毒携带者。2.进行 在跨国样本中评估WiseApp与常规护理对照相比的疗效和可持续性的RCT 在第3、6和12个月时讲西班牙语的PLWH。3.确定多层次的障碍和促进因素， 使用WiseApp。将对WiseApp进行混合方法、多利益相关方流程评估， 在实施研究综合框架的指导下进行。拟议项目建立在我们的 研究小组的初步数据，并利用了哥伦比亚大学和Clínica de Familia之间的紧密联系 这个项目的重要性进一步加强了利用拉丁美洲人在 纽约市的华盛顿高地社区，DR中不成比例的高艾滋病毒感染率，以及 重要的是，我们的研究重点是AHRQ优先人群， 特别是慢性病患者、市中心居民、低收入者和少数种族/民族人士。

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.