Dissemination of the WiseApp for Improving Health Outcomes Across Settings

项目总结 尽管努力实现联合国艾滋病规划署的95-95-95目标，但在抗逆转录病毒疗法(ART)的坚持方面仍然存在明显的缺陷 以及艾滋病毒携带者(PLWH)的病毒抑制。艾滋病毒治疗成功方面的差距尤其明显 在种族和少数民族人口中明显，特别是在美国东北部的拉丁裔中 和加勒比海。HIV疾病的进展和PLWH中的过早死亡主要归因于 对医疗保健的参与不足和对艾滋病毒治疗方案的坚持。及时获得抗逆转录病毒治疗和随后的 持续的抗逆转录病毒治疗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：U01PS003715) 种族/少数民族PLWH及其提供商，以识别移动设备的内容、特性、功能和界面 应用程序以改善健康结果，包括抗逆转录病毒治疗的坚持。在这一发现的基础上，医疗研究机构 Quality(AHRQ)为构建此应用程序提供了支持，并将其与支持PLWH的智能药丸盒(CleverCap)集成 实时自我监控他们的服药依从性。这个创新的工具，WiseApp，取代了目前的方法 使用链接到电子药盒的自我管理移动应用程序进行艺术坚持，目前正在进行评估 纽约市(NYC)的随机对照试验(RCT)(NCT03205982)。与此同时，有一种强烈的需求 用于为讲西班牙语的拉丁裔PLWH开发和测试自我管理干预措施，因为他们是 这是美国规模最大、增长最快的少数民族群体，受艾滋病毒感染的比例更高。我们建议 通过翻译和翻译测试WiseApp对美国和多米尼加共和国(DR)的拉丁裔的可转移性 在文化上对其进行适应，并进行多地点随机对照试验，以评估其疗效。拟议的项目与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方便收集和使用 患者报告的结果，包括服药依从性、生活质量和症状负担。这项研究将解决 具体目标如下：1.调整并确保WiseApp对讲西班牙语的PLWH的可用性。2.开展 在跨国样本中评估WiseApp与普通护理对照的疗效和可持续性的随机对照试验 在3个月、6个月和12个月时说西班牙语的PLWH。3.确定普及的多层次障碍和促进者 实施WiseApp。将对WiseApp进行混合方法、多利益相关者的流程评估 在实施研究综合框架的指导下进行。拟议的项目建立在我们的 团队强劲的初步数据，并利用了哥伦比亚大学和Clínica de Familia之间的强大联系 在Dr.中，这个项目的重要性通过利用拉美裔在世界上的强大存在而进一步增强 纽约市的华盛顿高地社区，DR中艾滋病毒高得不成比例的比率，以及 重要的是，我们的研究重点是AHRQ优先考虑的人群， 特别是患有慢性病、市中心、低收入和种族/少数民族的人。

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.