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; 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（PLWH）的人中，积极影响与较低的抑郁水平与众不同， 疾病的进展较慢，对药物的依从性更好，并获得抑制病毒的可能性较高 负载，独立于负面影响。在两个随机对照试验中，PLWH（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着有益作用 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 PLWH的自助，在线交付，积极影响技能干预的早期功效（R34 MH101265）。 现在，与芝加哥艾滋病基金会（AFC）合作，我们建议进行II型混合动力 心理健康的阶梯楔形群集随机试验（SW-CRT）的有效性实施研究 筛查和转介到兰花（通过互联网交付优化韧性和应对艾滋病毒）。这 拟议的研究是由AFC启动的，AFC开发了心理健康筛查并选择了SW-CRT 设计是一种学习实施的道德方式，同时确保所有患有抑郁症升高的客户都接受 干预。精神健康筛查 +兰花将通过所有医疗案例经理实施 （MCMS）在芝加哥的Ryan White资助的17个诊所。我们将使用Re-Aim框架来构建 有效性和实施结果以及实施研究的合并框架 （CFIR）了解患者和诊所水平的实施结果。具体目的是：（1） 运营实施促进策略，以将心理健康筛查与转介到兰花联系起来 在芝加哥的瑞安·怀特资助的诊所通过MCMS； （2）确定筛选 +兰花的有效性 为了改善抑郁症，保留护理和病毒抑制，在17 Ryan接受护理的300 plwwh中 白色临床部位，使用阶梯楔形群集随机设计。抑郁是主要结果， 在个体和临床水平上保留护理和病毒抑制是次要结果。和 （3）评估筛查 +兰花的实施，并迭代地完善后续步骤的策略。 拟议的研究具有巨大的希望，可以促进有关如何最好地整合和 回应瑞安·怀特诊所的心理健康筛查。来自混合动力试验的数据将导致可持续性， 可以在全国Ryan White Clinics中传播的可扩展计划，因此对 在艾滋病毒流行计划结束的国家终结目标中迈向芝加哥。