Patient-Centered eHealth Intervention for Non-adherent HIV+ Substance Users

 描述(由申请人提供)：坚持干预应解决不坚持和一系列共同出现的问题，这些问题破坏了坚持和参与护理。通过减少共生问题和提高自我管理技能，直接和间接地解决遵守问题，可以增加干预的效力。我们将测试一种创新的为期8周的以患者为中心的自我管理干预措施，该干预措施将提高经历高耻辱率、低社会支持率、物质使用和抑郁症的非城市PLWH的依从性。在这个为期两年的R34项目中，我们将构建一个eHealth互联网干预计划的原型，与患者和临床医生一起对其进行评估、改进，并测试其可行性，并承诺确定是否有必要进行后续的RCT。在第一阶段，我们将在一个成功的互联网干预平台上建立原型eHealth Positive，使用响应性设计原则，使其能够交付给患者设备。基础设施的规划和内容开发将同时进行。该原型包括带有日记的在线评估，以跟踪药物服用情况。它有8个核心，每周提供20-30分钟的循证干预。自动电子邮件会提示您登录。CORE将以知识为目标，并鼓励使用针对不遵守、抑郁、吸烟、吸毒、酗酒、耻辱和低社会支持/对披露的恐惧的策略。CORE将通过互动建立自我管理技能，让用户参与进来，定制反馈，并激励他们发现问题、练习技能和使用策略。每个核心还将以视频片段为特色 描绘非城市的艾滋病毒同龄人管理目标问题，并展示积极应对。视频小插曲将在CAB的指导下使用视觉参与式研究方法创建，确保材料以患者为中心。第二阶段是一项小型评估研究，测试eHealth阳性原型在10名患者和10名临床医生中的可用性和可接受性，然后对原型进行改进。在第三阶段，我们会在两间乡郊诊所招募50名妇女健康院，进行一项单一支援组试验计划及可行性试验。该试验将提供关于可接受性、可行性以及对坚持和每个目标问题的应对策略的知识和使用的影响的数据。可行性将通过招募、拒绝与同意、保留以及网络计划后端不引人注意地收集的使用数据来衡量，例如接触干预组件(即登录、已完成的核心、重复的组件、花费在交互上的时间等)。效果将通过在线核心前和核心后知识测试以及关于遵守和其他行为目标的应对策略使用情况的报告来衡量。我们将评估遵守和参与护理的候选客观结果指标的表现，如药房补充率和错过就诊比例，以及关于非法药物使用和问题饮酒的问卷数据，以用于随后的随机对照试验，以确定所需的样本量。如果电子健康干预达到可行性和前景的基准，将建议进行随机对照试验。

 DESCRIPTION (provided by applicant): Adherence interventions should address nonadherence and a set of co-occurring problems that undermine adherence and engagement in care. Addressing adherence directly and indirectly by reducing co-occurring problems and improving self-management skills could increase the potency of interventions. We will test an innovative 8-week patient-centered self-management intervention that will improve adherence among non- urban PLWH who experience high rates of stigma, low social support, substance use, and depression. In this 2-year R34 project, we will build a prototype eHealth Internet intervention program, evaluate it with patients and clinicians, refine it, and test it for feasibilty and promise to determine if a subsequent RCT is warranted. In Phase 1, we will build the prototype, eHealth Positive, on a successful Internet intervention platform, using principles of responsive design, to enable delivery to patient devices. Programming of the infrastructure and content development will proceed simultaneously. The prototype includes online assessments with diaries to track medication taking. It features 8 Cores that deliver 20-30 minute evidence-based interventions weekly. Logins are prompted by automated emails. Cores will target knowledge and encourage usage of strategies for nonadherence, depression, smoking, drug use, drinking, stigma, and low social support/fears of disclosure. Cores will build self-management skills with interactions that engage the user, tailor feedback, and motivate them to identify problems, practice skills, and use strategies. Each Core will also feature video vignettes depicting non-urban HIV+ peers managing the targeted issue, and demonstrating active coping. Video vignettes will be created using visual participatory research methods guided by a CAB, ensuring materials are patient-centered. Phase 2 is a small evaluation study testing the usability and acceptability of the eHealth Positive prototype among 10 patients and 10 clinicians, followed by improvements to the prototype. In Phase 3, we will conduct a single arm pilot and feasibility trial with 50 PLWH recruited from 2 rural- serving clinics. The trial will provide dataon acceptability, feasibility, and effects on knowledge and usage of coping strategies for adherence and each target problem. Feasibility will be measured by recruitment, refusal vs. consent, and retention, along with usage data that are gathered unobtrusively by the backend of the web program, such as exposure to intervention components (i.e., logins, Cores completed, components repeated, time spent on interactions, etc.) Effects will be measured from online pre-and post-Core knowledge tests and reports of usage of coping strategies for adherence and other behavioral targets. We will evaluate the performance of candidate objective outcome markers of adherence and engagement in care, such as pharmacy refill rate and missed visit proportion, along with questionnaire data on illicit drug use and problem drinking, for a subsequent RCT to determine the required sample size. If the eHealth intervention meets benchmarks for feasibility and promise, it will be recommended for an RCT.