一项针对参与 Ryan White 医疗病例管理的 HIV 感染者的积极情绪调节干预措施的混合 II 型有效性-实施试验：ORCHID 研究的方案和设计。

A hybrid type II effectiveness-implementation trial of a positive emotion regulation intervention among people living with HIV engaged in Ryan White Medical Case Management: protocol and design for the ORCHID study.

机构信息

Center of Population Science for Health Equity, College of Nursing, Florida State University, Tallahassee, FL, USA.

School of Social Work, Florida State University, Tallahassee, FL, USA.

出版信息

Trials. 2024 Sep 27;25(1):631. doi: 10.1186/s13063-024-08475-1.

DOI:10.1186/s13063-024-08475-1

PMID:39334472

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11428577/

Abstract

BACKGROUND

The Ryan White Medical Case Management System, which serves more than half of people living with HIV (PLWH) in the USA, is an opportune setting for identifying and addressing depression among PLWH. A growing body of research suggests that interventions that promote positive emotion may lessen symptoms of depression and improve physical and psychological well-being among people experiencing a variety of health-related stress, including living with HIV. Research on how best to integrate standardized mental health screening and referral to evidence-based interventions in Ryan White Medical Case Management settings has the potential to improve the health and wellbeing of PLWH.

METHODS

This mixed-methods study will enroll up to N = 300 Ryan White clients who screen positive for depressive symptoms in ORCHID (Optimizing Resilience and Coping with HIV through Internet Delivery), a web-based, self-guided positive emotion regulation intervention. The study will be conducted in 16 Ryan White Medical Case Management clinics in Chicago, IL. Following pre-implementation surveys and interviews with Medical Case Managers (MCMs) and Supervisors to develop an implementation facilitation strategy, we will conduct a hybrid type 2 implementation-effectiveness stepped wedge cluster randomized trial to iteratively improve the screening and referral process via interviews with MCMs in each wedge. We will test the effectiveness of ORCHID on depression and HIV care outcomes for PLWH enrolled in the program. RE-AIM is the implementation outcomes framework and the Consolidated Framework for Implementation Research is the implementation determinants framework.

DISCUSSION

Study findings have the potential to improve mental health and substance use screening of Ryan White clients, decrease depression and improve HIV care outcomes, and inform the implementation of other evidence-based interventions in the Ryan White Medical Case Management System.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05123144. Trial registered 6/24/2021.

摘要

背景

瑞安·怀特医疗个案管理系统（Ryan White Medical Case Management System）为美国一半以上的艾滋病毒感染者（PLWH）提供服务，是识别和解决 PLWH 抑郁问题的理想场所。越来越多的研究表明，促进积极情绪的干预措施可能会减轻抑郁症状，并改善经历各种与健康相关压力的人的身体和心理健康，包括感染艾滋病毒。研究如何最好地将标准化心理健康筛查和转介到基于证据的干预措施纳入瑞安·怀特医疗个案管理环境中，有可能改善 PLWH 的健康和幸福感。

方法

这项混合方法研究将招募多达 300 名在 ORCHID（通过互联网提供优化的韧性和应对艾滋病毒的能力）中筛查出抑郁症状呈阳性的瑞安·怀特客户，这是一种基于网络的、自我指导的积极情绪调节干预措施。该研究将在伊利诺伊州芝加哥的 16 个瑞安·怀特医疗个案管理诊所进行。在对医疗个案经理（MCM）和主管进行预实施调查和访谈以制定实施促进策略之后，我们将进行混合式 2 型实施有效性阶梯式楔形随机试验，通过对每个楔形中的 MCM 进行访谈，逐步改善筛查和转介过程。我们将测试 ORCHID 对参与该计划的 PLWH 的抑郁和艾滋病毒护理结果的有效性。RE-AIM 是实施结果框架，综合实施研究框架是实施决定因素框架。