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: 10405614
• 负责人: Alida M Bouris
• 金额: $ 62.91万
• 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/10405614
• 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; 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 evaluation; implementation facilitation; implementation framework; implementation outcomes; implementation strategy; improved; intervention effect; negative affect; online delivery; online intervention; pilot test; primary outcome; programs; resilience; screening; secondary outcome; sexual minority men; 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.

项目摘要 在艾滋病毒感染者（PLWH）中，积极的情感与较低的抑郁水平有独特的联系， 更慢的疾病进展，更好的药物依从性，更高的可能性实现抑制病毒 独立于负面影响。在两项PLWH随机对照试验（R 01 MH 084723; R 01 DA 033854），我们已经证明了旨在增加积极影响的干预措施的显著有益效果 病毒抑制和心理健康我们还证明了可行性、可接受性和 PLWH自我引导、在线提供、积极情感技能干预的早期疗效（R34 MH 101265）。 现在，在与芝加哥艾滋病基金会（AFC）的合作下，我们建议进行一项混合II型 心理健康阶梯楔形分组随机试验的有效性-实施研究 筛选和转诊到ORCHID（通过互联网交付优化弹性和应对艾滋病毒）。的 拟议的研究由AFC发起，该研究开发了心理健康筛查并选择了SW-CRT 设计作为一种道德的方式来研究实施，同时确保所有抑郁症患者都能接受 干预。精神健康筛查+ ORCHID将通过所有医疗个案管理员实施 在芝加哥的17家瑞安怀特资助的诊所。我们将使用RE-AIM框架来构建 执行情况研究综合框架的执行情况 （CFIR）了解患者和诊所层面的实施结果。具体目标是：（1） 实施一项促进执行战略，将精神健康筛查与转诊到ORCHID联系起来 通过芝加哥Ryan White资助的诊所的MCM;（2）确定筛查+ ORCHID的有效性 在17 Ryan接受治疗的300名PLWH中， 白色临床研究中心，采用阶梯楔形分组随机化设计。抑郁是主要结局， 在个人和诊所层面保持护理和病毒抑制是次要结局; (3)评估筛选+ ORCHID的实施情况，并迭代地完善后续步骤的策略。 拟议的研究为推进当前关于如何最好地整合和 在瑞安白色诊所接受心理健康检查。来自混合试验的数据将导致一个可持续的， 可扩展的计划，可以在全国范围内的瑞安白色诊所传播，从而持有重大承诺， 推动芝加哥实现国家终止艾滋病毒流行计划的目标。