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

 描述（由申请人提供）：依从性干预措施应解决不依从性和一系列破坏依从性和参与护理的并发问题。通过减少共同发生的问题和提高自我管理技能，直接和间接地解决遵守问题，可以提高干预措施的效力。我们将测试一种创新的8周以患者为中心的自我管理干预，该干预将提高非城市PLWH的依从性，这些PLWH经历了高比例的耻辱，低社会支持，物质使用和抑郁症。在这个为期2年的R34项目中，我们将建立一个原型电子健康互联网干预计划，与患者和临床医生一起评估，完善它，并测试它的可行性，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构建原型eHealth Positive，使用响应式设计原则，以便向患者设备提供服务。基础设施的规划和内容开发将同时进行。该原型包括在线评估和日记，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。登录由自动电子邮件提示。核心将以知识为目标，并鼓励使用针对不遵守、抑郁、吸烟、吸毒、饮酒、耻辱和社会支持低/害怕披露的策略。核心将建立自我管理技能与互动，使用户参与，定制反馈，并激励他们发现问题，实践技能，并使用策略。每个核心还将具有视频小插曲 描述非城市艾滋病毒阳性同伴管理目标问题，并展示积极应对。将使用CAB指导的视觉参与性研究方法创建视频短片，确保材料以患者为中心。第2阶段是一项小型评估研究，在10名患者和10名临床医生中测试eHealth Positive原型的可用性和可接受性，然后对原型进行改进。在第三阶段，我们会从两间乡郊诊所招募50名艾滋病病毒携带者，进行单组试验及可行性试验。该试验将提供数据的可接受性，可行性，以及对知识和使用的依从性和每个目标问题的应对策略的影响。可行性将通过招募、拒绝与同意、保留沿着网络程序后端不引人注目地收集的使用数据来衡量，例如暴露于干预组件（即，登录、完成的核心、重复的组件、交互花费的时间等）将通过在线核心知识测试前和测试后以及使用应对策略以实现依从性和其他行为目标的报告来衡量效果。我们将评估候选客观结局指标的依从性和参与护理的表现，如药房再填充率和错过访视比例，沿着关于非法药物使用和问题饮酒的问卷数据，以确定后续RCT所需的样本量。如果电子健康干预措施符合可行性和承诺的基准，将推荐用于RCT。

 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.