The Wise App Trial for Improving Health Outcomes in PLWH

用于改善 PLWH 健康结果的 Wise 应用试验

• 批准号: 10013220
• 负责人: Rebecca Schnall
• 金额: $ 39.25万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-30 至 2022-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10013220
• 关键词: Wise; App; Trial; Improving; Health

The Wise App Trial for Improving Health Outcomes in PLWH Human Immunodeficiency virus (HIV) continues to affect 1.2 million Americans. Achieving viral suppression through adherence to antiretroviral (ART) therapy is a critical determinant of successful transmission prevention and long-term outcomes in HIV-infected patients. However only about 25% of persons living with HIV (PLWH) in the US are virally suppressed, demonstrating the need for effective interventions that enhance ART adherence. mHealth is a tool that has proven useful in supporting behavior change, but most mHealth tools for PLWH have not been well-developed or evaluated. Given the dearth of useful and likeable apps, the need for improving medication adherence in PLWH, and the great promise of mHealth, we propose to build and test a user-centered smartphone app linked to a smart pill box targeting ART adherence in PLWH. Self- report of medication adherence is often criticized since it typically overestimated adherence especially in unmasked trials. Current adherence assessments, such as patient recall, pill counts and pharmacy refill data, typically detect missed doses long after they occur. Our study will use real-time, wireless monitoring strategies via the Wisepill dispenser, for measuring ART adherence. This will overcome this often cited limitation and provide novel opportunities to proactively prevent virologic rebound and treatment failure. Guided by Fogg's Functional Triad for persuasive technology and building on our earlier user-centered design work, the proposed intervention has the potential to not only improve ART adherence in PLWH, but also have a sustainable public health impact. The aims of our study are to: (1) Build a functional app for HIV self- management linked to a smart pill box (Wise App) for PLWH and assess its usability; (2) Evaluate the impact of the Wise App on medication adherence in underserved PLWH; and (3) Assess PLWH perceptions of the predisposing, enabling, and reinforcing factors for Wise App use through theoretically-guided focus group sessions. The proposed study extends our preliminary work that employed user-centered design methods to identify the content, features, functionalities, and interface of a mobile app to improve health outcomes in PLWH. The user-centered design app we will build will then be linked to a smart pill box so that PLWH can receive feedback on their adherence behaviors. Our study intervention, the Wise App, is relevant, timely, of public health import, and supported by substantial preliminary work. The proposed trial is significant in representing a principled and systematic effort to build, and test the efficacy of a smartphone intervention for ART adherence in PLWH in the US. Importantly, this work has broader implications and will improve our understanding of how to support patients' medication adherence, regardless of treatment target.

用于改善 PLWH 健康结果的 Wise 应用试验 人类免疫缺陷病毒 (HIV) 继续影响着 120 万美国人。实现病毒抑制 坚持抗逆转录病毒 (ART) 治疗是成功传播的关键决定因素 HIV 感染者的预防和长期结果。然而，只有约 25% 的人患有 美国的艾滋病毒（PLWH）受到病毒抑制，这表明需要采取有效的干预措施来加强 艺术坚持。事实证明，移动医疗是一种在支持行为改变方面非常有用的工具，但大多数移动医疗 针对艾滋病毒感染者的工具尚未得到充分开发或评估。鉴于缺乏有用且令人喜爱的应用程序， 提高 PLWH 药物依从性的需求以及移动医疗的巨大前景，我们建议建立 并测试一个以用户为中心的智能手机应用程序，该应用程序与一个智能药盒相连，旨在帮助艾滋病患者坚持接受抗逆转录病毒治疗。自己- 药物依从性报告经常受到批评，因为它通常高估了依从性，尤其是在 揭露的审判。当前的依从性评估，例如患者回忆、药丸计数和药房补充数据， 通常在漏服剂量发生很久之后才发现。我们的研究将使用实时无线监控策略 通过 Wisepill 分配器，用于测量 ART 依从性。这将克服这个经常被引用的限制 提供主动预防病毒学反弹和治疗失败的新机会。在福格的指导下 用于说服性技术的功能三合一，并建立在我们早期以用户为中心的设计工作的基础上， 拟议的干预措施不仅有可能提高 PLWH 的 ART 依从性，而且还具有 可持续的公共卫生影响。我们研究的目的是：(1) 构建一个针对 HIV 自我检测的功能性应用程序 管理人员与感染者的智能药盒（Wise App）相连并评估其可用性； (2) 评估影响 Wise 应用程序对服务不足的 PLWH 患者用药依从性的影响； (3) 评估 PLWH 对 通过理论指导的焦点小组为 Wise App 使用提供诱发因素、促成因素和强化因素 会议。拟议的研究扩展了我们采用以用户为中心的设计方法的初步工作 确定移动应用程序的内容、特性、功能和界面，以改善健康状况 感染者。我们将构建的以用户为中心的设计应用程序将链接到智能药盒，以便 PLWH 可以 接收有关他们遵守行为的反馈。我们的研究干预 Wise App 是相关的、及时的 公共卫生导入，并得到大量前期工作的支持。拟议的试验具有重要意义 代表了一项原则性和系统性的努力，旨在建立和测试智能手机干预的有效性 美国 PLWH 中 ART 的坚持情况。重要的是，这项工作具有更广泛的影响，并将改善我们的 了解如何支持患者坚持用药，无论治疗目标如何。