The Wise App Trial for Improving Health Outcomes in PLWH

用于改善PLWH健康结果的Wise App试用 人类免疫缺陷病毒（HIV）继续影响着120万美国人。达到病毒抑制 通过坚持抗逆转录病毒（ART）治疗是成功传播的关键决定因素 艾滋病病毒感染者的预防和长期结果。然而，只有大约25%的人生活在 美国的艾滋病毒（PLWH）受到病毒抑制，表明需要有效的干预措施， 坚持抗逆转录病毒疗法。mHealth是一种已被证明在支持行为改变方面有用的工具，但大多数mHealth 针对艾滋病毒携带者和艾滋病患者的工具尚未得到很好的开发或评估。由于缺乏有用和可爱的应用程序， 需要提高药物治疗的依从性在PLWH，和mHealth的巨大希望，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，该应用程序链接到一个智能药盒，目标是PLWH的ART依从性。自我 药物依从性的报告经常受到批评，因为它通常高估了依从性，特别是在 无盲试验目前的依从性评估，如患者召回、药丸计数和药房续药数据， 通常在漏服剂量发生很久之后才检测到漏服剂量。我们的研究将使用实时无线监测策略 通过Wisepill分配器，用于测量ART依从性。这将克服这一经常被引用的限制， 为主动预防病毒反弹和治疗失败提供了新的机会。由福格指导 功能三元组的说服力技术和建设，我们早期的以用户为中心的设计工作， 拟议的干预措施不仅有可能改善艾滋病病毒携带者的抗逆转录病毒治疗依从性， 可持续的公共卫生影响。本研究的目的是：（1）构建一个艾滋病自我管理的功能性应用程序， 管理链接到PLWH的智能药盒（Wise App），并评估其可用性;（2）评估影响 （3）评估PLWH对药物治疗依从性的看法， 通过理论指导的焦点小组，了解Wise App使用的诱发、促成和强化因素 sessions.这项研究扩展了我们的前期工作，采用以用户为中心的设计方法， 确定移动的应用程序的内容、特性、功能和界面，以改善健康结果， PLWH。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 接受关于他们遵守行为的反馈。我们的研究干预措施，Wise App，是相关的，及时的， 公共卫生的重要性，并得到大量前期工作的支持。拟议的审判在以下方面具有重要意义： 代表一个原则性和系统性的努力，建立和测试智能手机干预的有效性， 美国PLWH患者的ART依从性。重要的是，这项工作具有更广泛的影响，将改善我们的 了解如何支持患者的药物依从性，无论治疗目标如何。

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.