mHealth Facilitated Intervention to Improve Medication Adherence among Persons Living with HIV

美国有100多万艾滋病毒携带者。尽管...的有效性 抗逆转录病毒治疗(ART)、病毒抑制，特别是持久的病毒抑制，可能很难实现。 不良的抗逆转录病毒治疗依从性在不成功的病毒抑制中起着重要作用，这增加了风险。 疾病进展，寿命缩短，传染给他人，以及治疗的发展 艾滋病毒耐药株。因此，制定了以坚持为目标的干预措施。曾经有过 一些成功的迹象，特别是通过更密集的干预。然而，有必要发展 有效的ART依从性干预措施，易于传播，并有效利用现有的 资源。为此，皮拉姆齐开发并测试了一种mHealth促进的ART坚持干预 这包括由健康教练讲授一次面对面的ART坚持课程，然后是12个月 访问应用程序和通过该应用程序提供的健康指导。应用程序会生成推送通知 健康教练可以通过“仪表板”获得药物提醒和依从性数据，从而使 健康教练实时监控遵守情况并提供支持。健康教练使用双向安全装置 应用程序上的消息传递功能向消息参与者发送消息，并提供支持、鼓励和资源， 包括链接和附件，以响应遵守失效和参与者生成的 留言。面对面干预组件和APP相结合促进了健康 辅导代表了一种新颖的组合，为参与者提供了与健康教练的个人联系 同时最大限度地减少提供干预所需的资源，并最大限度地提高对 遵守失效和其他参与者需求。一项初步随机对照试验(RCT)比较了 对参与者接受单一面对面ART依从性治疗的对照条件的干预 独自一人。基于试点数据，该方案和干预措施是高度可行和可接受的，结果是 符合干预的初步疗效，客观衡量ART的依从性。建议数 这项研究将扩展使用全功率RCT(n=400)进行的这项干预的初步测试 地点(国际扶轮普罗维登斯和佐治亚州亚特兰大)。这一研究的长期目标是传播一种 有效的，mHealth促进了ART依从性干预，可以很容易地整合到临床护理中。这个 目前的提案将审查干预相对于控制对电子地堡艺术的影响 依从性和病毒载量数据。此外，我们还将探讨理论上支持的变量在 干预效果的调节和调节。面谈将在基线、1、3、6和12处进行 月份。一部分参与者还将在18个月和24个月时完成访谈，以探索持续的 干预效果。如果被发现有效，这种干预可以广泛地整合到艾滋病毒的临床护理中， 以有效利用现有资源的方式减少艾滋病患者的发病率和死亡率。

There are more than a million persons living with HIV in the United States. Despite the effectiveness of antiretroviral therapy (ART), viral suppression, particularly durable viral suppression, can be difficult to achieve. Suboptimal ART adherence plays a significant role in unsuccessful viral suppression, which increases the risk of disease progression, a shortened lifespan, transmission to others, and the development of treatment resistant strains of HIV. As a result, interventions targeting adherence have been developed. There have been some signs of success, particularly with more intensive interventions. However, there is a need to develop efficacious ART adherence interventions that are readily disseminable and make efficient use of available resources. To that end, PI Ramsey developed and tested an mHealth facilitated ART adherence intervention that includes a single face-to-face ART adherence session delivered by a health coach, followed by 12 months of access to an app and health coaching delivered via the app. The app generates a push notification medication reminder, and adherence data are available to the health coach via a “dashboard,” allowing the health coach to monitor adherence in real time and provide support. The health coach uses a two-way secure messaging feature on the app to message participants and to provide support, encouragement, and resources, including links and attachments, in response to adherence lapses and in response to participant-generated messages. The combination of a face-to-face intervention component followed by app facilitated health coaching represents a novel combination that affords participants with a personal connection to a health coach while minimizing the resources needed to deliver the intervention and maximizing timely responsiveness to adherence lapses and other participant needs. A preliminary randomized controlled trial (RCT) compared the intervention to a control condition in which participants received the single face-to-face ART adherence session alone. Based on pilot data, the protocol and intervention are highly feasible and acceptable, and results are consistent with preliminary efficacy of the intervention on objective measures of ART adherence. The proposed study will expand on this preliminary test of the intervention using a fully powered RCT (n=400) across two sites (Providence, RI and Atlanta, GA). The long-term goal of this line of research is to disseminate an efficacious, mHealth facilitated ART adherence intervention that can be readily integrated into clinical care. The present proposal will examine the impact of the intervention, relative to control, on electronic pillbox ART adherence and viral load data. In addition, we will explore the role of theoretically supported variables in the mediation and moderation of intervention effects. Interviews will be conducted at baseline, 1, 3, 6, and 12 months. A subset of participants will also complete interviews at 18 and 24 months to explore sustained intervention effects. If found efficacious, the intervention could be broadly integrated into clinical care for HIV, reducing morbidity and mortality among PLWH in a manner that makes efficient use of available resources.