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

项目摘要 在艾滋病毒携带者(PLWH)中，积极的情绪与较低的抑郁水平有独特的联系， 疾病进展较慢，更好地坚持服药，实现病毒抑制的可能性更高 负荷，不受负面影响。在两个使用PLWH的随机对照试验中(R01 MH084723；R01 (DA033854)，我们已经显示出旨在增加积极影响的干预措施的显著有益效果 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 自我指导、在线提供的积极情感技能干预对PLWH的早期疗效(R34 MH101265)。 现在，在芝加哥艾滋病基金会(AFC)的合作下，我们提议进行第二型杂交 阶梯式楔形整群随机试验(SWCRT)的有效性-实施研究 对兰花进行筛查和转介(通过互联网传播优化复原力和应对艾滋病毒)。这个 建议的研究是由AFC发起的，他们开发了心理健康筛查并选择了SW-CRT 将设计作为研究实施情况的一种道德方式，同时确保所有抑郁程度升高的患者 干预行动。心理健康筛查兰花将通过所有医疗病例经理实施 (MCMS)在芝加哥的17家瑞安·怀特资助的诊所进行。我们将使用RE-AIM框架来构建 有效性和执行成果以及执行研究综合框架 (CFIR)以了解患者和临床层面的实施结果。具体目标是：(1) 实施实施促进战略，将心理健康筛查与转介兰花联系起来 通过芝加哥瑞安·怀特资助的诊所的MCM；(2)确定筛查兰花的有效性 在17 Ryan接受护理的300名PLWH中，用于改善抑郁、保持护理和病毒抑制 白色临床点位，采用阶梯楔形整群随机设计。抑郁症是主要的结果， 个人和临床层面的保留护理和病毒抑制是次要结果；以及 (3)评估兰花筛选的实施情况，并迭代细化后续步骤的策略。 这项拟议的研究对促进当前关于如何最好地整合和 对瑞安·怀特诊所的心理健康筛查做出回应。来自混合试验的数据将导致可持续的、 可扩展的计划，可以在全国范围内的瑞安·怀特诊所传播，从而为 推动芝加哥朝着国家终止艾滋病毒流行计划的目标前进。

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.