A Stepped Wedge Hybrid Type II Trial of an Online Positive Affect Intervention: Blending Implementation and Effectiveness to Improve HIV Continuum Outcomes in Ryan White Clinics in Chicago

在线积极情感干预的阶梯式楔形混合 II 型试验：将实施和有效性相结合，以改善芝加哥 Ryan White 诊所的 HIV 连续结果

• 批准号: 10217028
• 负责人: Alida M Bouris
• 金额: $ 62.42万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-15 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10217028
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adherence; Adoption; Affect; Area; Caring; Case Manager; Characteristics; Chicago; Cities; Client; Clinic; Clinical; Cluster randomized trial; Collaborations; Consolidated Framework for Implementation Research; Data; Disease Progression; Drug usage; Effectiveness; Ensure; Epidemic; Ethics; Focus Groups; Foundations; Funding; General Population; Goals; HIV; HIV Seropositivity; Health Personnel; Human immunodeficiency virus test; Hybrids; Individual; Internet; Intervention; Intervention Studies; Knowledge; Link; Maintenance; Medical; Mental Depression; Mental Health; Modeling; Outcome; Participant; Patients; Persons; Pharmaceutical Preparations; Plague; Preparation; Process; Randomized; Randomized Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Research; Rural; Sampling; Site; Structure; Substance abuse problem; Surveys; System; Testing; United States Health Resources and Services Administration; Viral; Viral Load result; Waiting Lists; Well in self; Work; base; care outcomes; clinical research site; comorbidity; coping; design; effectiveness analysis; effectiveness evaluation; effectiveness implementation study; effectiveness implementation trial; effectiveness outcome; hybrid type 2 design; hybrid type 2 trial; implementation facilitation; implementation framework; implementation outcomes; implementation strategy; improved; intervention effect; men; negative affect; online delivery; online intervention; primary outcome; programs; resilience; screening; secondary outcome; sexual minority; skills; standard of care; success; trial design

Project Summary Among people living with HIV (PLWH), positive affect is uniquely associated with lower levels of depression, slower disease progression, better adherence to medication, and higher likelihood of achieving suppressed viral load, independent of negative affect. In two randomized controlled trials with PLWH (R01 MH084723; R01 DA033854), we have shown significant beneficial effects of an intervention that aims to increase positive affect on viral suppression and psychological well being. We also have demonstrated feasibility, acceptability, and early efficacy of a self-guided, online-delivered, positive affect skills intervention for PLWH (R34 MH101265). Now, in collaboration with the AIDS Foundation of Chicago (AFC), we propose to conduct a Hybrid Type II effectiveness-implementations study of a stepped wedge cluster randomized trial (SW-CRT) of mental health screening and referral to ORCHID (Optimizing Resilience and Coping with HIV through Internet Delivery). The proposed study was initiated by AFC, which developed the mental health screening and selected the SW-CRT design as an ethical way to study implementation while ensuring that all clients with elevated depression receive the intervention. Mental health screening + ORCHID will be implemented through all medical case managers (MCMs) at 17 Ryan White-funded clinics in Chicago. We will use the RE-AIM framework to structure the effectiveness and implementation outcomes and the Consolidated Framework for Implementation Research (CFIR) to understand the implementation outcomes at the patient and clinic levels. The specific aims are to: (1) Operationalize an implementation facilitation strategy to link mental health screening with referral to ORCHID through MCMs at Ryan White-funded clinics in Chicago; (2) Determine the effectiveness of screening + ORCHID for improving depression, retention in care, and viral suppression, among 300 PLWH receiving care at 17 Ryan White clinical sites, using a stepped wedge cluster randomized design. Depression is the primary outcome and retention in care and viral suppression at both the individual and clinic level are the secondary outcomes; and (3) Evaluate the implementation of screening + ORCHID and iteratively refine the strategy for subsequent steps. The proposed research holds significant promise for advancing current knowledge on how best to integrate and respond to mental health screening in Ryan White clinics. Data from the hybrid trial will result in a sustainable, scalable program that can be disseminated in Ryan White clinics nationwide, thus holding significant promise for advancing Chicago toward goals in the National Ending the HIV Epidemic Plan.

项目概要 在艾滋病毒感染者（PLWH）中，积极的情绪与较低的抑郁水平有着独特的联系， 疾病进展较慢，药物依从性更好，实现病毒抑制的可能性更高 负载，与负面影响无关。在两项针对 PLWH 的随机对照试验中（R01 MH084723；R01 DA033854），我们已经展示了旨在增加积极影响的干预措施的显着有益效果 关于病毒抑制和心理健康。我们还证明了可行性、可接受性和 对 PLWH 进行自我指导、在线提供的积极情感技能干预的早期疗效 (R34 MH101265)。 现在，我们与芝加哥艾滋病基金会 (AFC) 合作，建议进行 II 型混合治疗 心理健康阶梯楔形聚类随机试验（SW-CRT）的有效性实施研究 筛查并转介至 ORCHID（通过互联网交付优化恢复力和应对艾滋病毒）。这 拟议的研究由 AFC 发起，AFC 开发了心理健康筛查并选择了 SW-CRT 设计作为研究实施的道德方式，同时确保所有患有抑郁症的客户都能得到 的干预。心理健康筛查+ORCHID将在所有病例管理者中实施 （MCM）在芝加哥 17 个 Ryan White 资助的诊所。我们将使用 RE-AIM 框架来构建 有效性和实施成果以及实施研究综合框架 (CFIR) 了解患者和诊所层面的实施结果。具体目标是：（1） 实施一项实施促进策略，将心理健康筛查与转介至 ORCHID 联系起来 通过 Ryan White 资助的芝加哥诊所的 MCM； (2)确定筛选+ORCHID的有效性 改善在 17 Ryan 接受护理的 300 名感染者的抑郁症、护理保留率和病毒抑制 白色临床站点，采用阶梯式楔形聚类随机设计。抑郁症是主要结局 个人和诊所层面的护理保留和病毒抑制是次要结果；和 （3）评估筛选+ORCHID的实施情况，并迭代细化后续步骤的策略。 拟议的研究对于推进当前关于如何最好地整合和利用知识的知识具有重大前景。 对 Ryan White 诊所的心理健康检查做出回应。混合试验的数据将产生可持续的、 可扩展的计划，可以在全国范围内的 Ryan White 诊所传播，从而为 推动芝加哥实现国家终结艾滋病毒流行计划的目标。