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

针对非依从性艾滋病毒药物使用者的以患者为中心的电子健康干预

• 批准号: 8845347
• 负责人: KAREN S INGERSOLL
• 金额: $ 35.55万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-02-01 至 2017-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8845347
• 关键词: Address; Adherence; Affect; Alcohol abuse; Alcohol or Other Drugs use; Anti-Retroviral Agents; Anxiety; Behavior; Behavioral; Benchmarking; Car Phone; Caring; Chronic; Chronic Disease; Clinic; Complement; Consent; Data; Development; Devices; Disclosure; Disease; Disease Progression; Dropout; Drug usage; Drug user; Electronic Mail; Elements; Enrollment; Ensure; Evaluation; Evaluation Studies; Evidence based intervention; Exposure to; Feedback; Fright; Future; HIV; Health; Health behavior; Home environment; Illicit Drugs; Internet; Intervention; Interview; Knowledge; Life; Link; Measures; Mental Depression; Mental disorders; Methods; Modification; Online Systems; Outcome; Patients; Performance; Pharmaceutical Preparations; Pharmacy facility; Phase; Population; Poverty; Questionnaires; Randomized Clinical Trials; Recruitment Activity; Reporting; Research; Research Infrastructure; Research Methodology; Research Personnel; Risk Factors; Rural; Sample Size; Self Management; Shapes; Smoking; Social support; Structure; Technology; Testing; Time; Visit; Visual; arm; base; computerized data processing; coping; design; diaries; drinking; eHealth; evidence base; experience; high risk drinking; improved; innovation; intervention program; meetings; patient oriented; peer; pilot trial; prevent; primary outcome; programs; prototype; public health relevance; racial and ethnic; skills; social stigma; socioeconomic disparity; stressor; treatment adherence; usability

 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.

 描述（由申请人提供）：依从性干预措施应解决不依从性以及一系列同时出现的破坏依从性和参与护理的问题。通过减少同时发生的问题和提高自我管理技能来直接和间接解决依从性问题可以提高干预措施的效力。我们将测试一项为期 8 周、以患者为中心的创新自我管理干预措施，该干预措施将提高非城市感染者的依从性，这些感染者经历了高耻辱、低社会支持、药物滥用和抑郁症。在这个为期 2 年的 R34 项目中，我们将构建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对其进行评估，对其进行完善，并测试其可行性，并承诺确定是否有必要进行后续随机对照试验。在第一阶段，我们将使用响应式设计原则，在成功的互联网干预平台上构建原型 eHealth Positive，以实现向患者设备的交付。基础设施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，以跟踪用药情况。它具有 8 个核心，每周提供 20-30 分钟的循证干预措施。自动电子邮件会提示登录。核心将以知识为目标，并鼓励使用针对不依从、抑郁、吸烟、吸毒、酗酒、耻辱和低社会支持/担心披露的策略。核心将通过与用户互动、定制反馈并激励他们发现问题、练习技能和使用策略的互动来培养自我管理技能。每个核心还将包含视频片段 描绘非城市艾滋病病毒感染者同龄人管理目标问题并表现出积极的应对方式。视频片段将使用 CAB 指导下的视觉参与式研究方法来创建，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，我们将从 2 个农村服务诊所招募 50 名 PLWH，进行单臂试点和可行性试验。该试验将提供有关依从性应对策略和每个目标问题的可接受性、可行性以及对知识和使用的影响的数据。可行性将通过招募、拒绝与同意、保留以及网络程序后端不引人注目地收集的使用数据来衡量，例如接触干预组件（即登录、完成核心、重复组件、互动所花费的时间等）。效果将通过在线核心前和后知识测试以及针对依从性和其他行为的应对策略的使用报告来衡量。 目标。我们将评估护理依从性和参与度的候选客观结果指标的表现，例如药房补充率和漏诊比例，以及有关非法药物使用和饮酒问题的问卷数据，以便后续随机对照试验确定所需的样本量。如果电子卫生干预措施满足可行性和承诺的基准，将建议进行随机对照试验。