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

移动医疗促进干预措施，提高艾滋病毒感染者的用药依从性

• 批准号: 10328274
• 负责人: Susan E Ramsey
• 金额: $ 71.22万
• 依托单位: RHODE ISLAND HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-13 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10328274
• 关键词: Address; Adherence; Age; Behavioral; Centers for Disease Control and Prevention (U.S.); Clinical; Data; Development; Disease Progression; Dose; Effectiveness; Goals; HIV; Health; Individual; Intervention; Interview; Link; Literature; Longevity; Measures; Mediation; Minor; Monitor; Morbidity - disease rate; Motivation; Notification; Participant; Patients; Persons; Pharmaceutical Preparations; Pilot Projects; Play; Protocols documentation; Public Health; Randomized; Randomized Controlled Trials; Research; Resources; Risk; Role; Sampling; Secure; Self Efficacy; Site; Testing; Time; Treatment Efficacy; United States; Viral; Viral Load result; Virus; Work; acceptability and feasibility; antiretroviral therapy; base; clinical care; comparison intervention; cost; dashboard; disorder risk; efficacious intervention; fitbit; follow-up; improved; interest; intervention effect; intervention refinement; mHealth; medication compliance; medication nonadherence; mortality; multi-component intervention; novel; pilot test; recruit; resistant strain; response; sex; skills; smartphone Application; success; therapy adherence; therapy development; transmission process; treatment effect; viral transmission

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.

在美国，有超过一百万人感染艾滋病毒。尽管有效的 抗逆转录病毒疗法（ART）、病毒抑制、特别是持久的病毒抑制可能难以实现。 次优的ART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，传播给他人，以及治疗的发展 艾滋病毒的耐药菌株。因此，针对依从性的干预措施已经开发出来。有 有一些成功的迹象，特别是通过更密集的干预措施。然而，有必要发展 有效的抗逆转录病毒治疗依从性干预措施，易于传播，并有效利用现有的 资源为此，PI Ramsey开发并测试了一种mHealth促进ART依从性干预措施 其中包括由健康教练提供的一次面对面的ART依从性会议， 访问应用程序和通过应用程序提供的健康指导。应用程序生成推送通知 药物提醒和依从性数据可通过“仪表板”提供给健康教练， 健康教练以真实的时间监测依从性并提供支持。健康教练使用双向安全 应用程序上的消息传递功能，用于向参与者发送消息，并提供支持，鼓励和资源， 包括链接和附件，以响应遵守失误和响应参与者生成的 充分和传播面对面干预与应用程序相结合促进了健康 教练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， 遵守失误和其他参与者的需求。一项初步的随机对照试验（RCT）比较了 干预控制条件，其中参与者接受了单次面对面的ART依从性会话 一个人根据试点数据，该方案和干预措施是高度可行和可接受的，结果是 这与干预措施对ART依从性客观指标的初步疗效一致。拟议 这项研究将使用一项完全有效的随机对照试验（n=400），在两个样本中对干预措施的初步测试进行扩展。 研究中心（普罗维登斯，RI和亚特兰大，GA）。这项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。的 目前的建议将审查干预的影响，相对于控制，对电子药盒艺术 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 干预效果的中介和调节作用。访谈将在基线、1、3、6和12时进行 个月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。如果发现有效，这种干预措施可以广泛地纳入艾滋病毒的临床护理， 以有效利用现有资源的方式降低艾滋病毒/艾滋病感染者的发病率和死亡率。