Integrating a Stepped Care Model of Screening and Treatment for Depression into Malawi's National HIV Care Delivery Platform

项目摘要 这项提案汇集了来自美国和欧洲的心理健康和艾滋病毒服务提供方面的顶尖专家， 马拉维机构，包括马拉维卫生部，评估有效性， 纳入马拉维的循证抑郁症护理阶梯模式的成本效益 国家艾滋病毒平台。马拉维是世界上艾滋病毒感染率第九高的国家，人均国内生产总值第二低。 资本。此外，抑郁症是残疾的主要原因，但在90%以上的病例中仍未得到治疗。 缺乏经济高效、可扩展的解决方案是一个根本障碍。在这种背景下，一个重大的成功 扩大了由709个艾滋病毒诊所组成的网络，有50多万病人参加了抗逆转录病毒治疗。 慢性病护理系统配备专门的人力资源和基础设施，这为以下方面提供了一个战略平台： 整合抑郁症护理，并回应了一个强大的证据基础，概述了双向性， 抑郁症和艾滋病的结果。研究小组的成员已经成功地在 邻近地区，证明可行性，可接受性和初步疗效。此外，该团队还 已经将高血压和糖尿病等其他非传染性疾病的治疗纳入其中 马拉维Neno区艾滋病毒护理系统。此外，团队成员成功地将抑郁症 在类似的环境中将抑郁症护理纳入艾滋病毒服务（乌干达），并建立了抑郁症护理模式， 解决治疗（PST）在整个撒哈拉以南非洲的设置，除了进行形成性的工作， 马拉维的抑郁症患病率、筛查和诊断工具。在此基础上，我们将评估黄金 抑郁症护理的标准阶梯模型，将基于小组的PST与抗抑郁治疗相结合 (ADT)在n=420例中度/重度抑郁症（PHQ-9>10）患者中，遵循阶梯式楔形簇 随机设计，其中14个设施被随机化，在15个月内分5个步骤实施该模型 期主要结局（抑郁症状、功能障碍和总体健康状况）和次要结局 结局（例如HIV：病毒载量、ART依从性;糖尿病：A1 C水平;高血压：收缩压） 将每三个月测量一次，包括基线、治疗前、治疗后（3个月）、6个月和 12个月随访。我们还将从三个方面评估该模式是否适合在国家一级推广： 成本效益、可行性和研究能力。成本效益将检查直接治疗效果， 抑郁症状，以及对（a）共病状况和（B）护理负担的间接益处， 参与者的家庭成员。将通过关键知情人访谈（n=20）评估可行性 研究参与者和n=10个供应商。将通过以下方式支持研究能力：㈠大学课程， 在3-5年制定的实地安置，（ii）当地研究导师计划，以及（iii）培训协议， 抑郁症护理包，包括评估工具，在第五年开始在全国推广。

PROJECT SUMMARY This proposal brings together leading experts on mental health and HIV service delivery from top US and Malawian institutions, including the Malawian Ministry of Health (MOH), to evaluate the effectiveness and cost-effectiveness of an evidence-based stepped model of depression care integrated into Malawi's national HIV platform. Malawi has the 9th highest HIV prevalence in the world, and the 2nd lowest GDP per capita. Additionally, depression is a leading cause of disability but remains untreated in over 90% of cases. Lack of cost-effective, scalable solutions is a fundamental barrier. Against this backdrop, one major success has been the scale-up of a network of 709 HIV clinics, with over half a million patients enrolled in ART. As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care, and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes. Members of the research team have already successfully piloted this model in a neighboring district, demonstrating feasibility, acceptability and preliminary efficacy. Moreover, the team has already integrated treatment for other non-communicable diseases such as hypertension and diabetes into the HIV care system of Neno District, Malawi. Additionally, team members have successfully integrated depression care into HIV services in similar settings (Uganda) and instituted depression care models such as Problem Solving Therapy (PST) in settings throughout sub-Saharan Africa, in addition to conducting formative work on depression prevalence, screening and diagnostic tools in Malawi. Building from this, we will evaluate a gold standard stepped model of depression care that combines group-based PST with antidepressant therapy (ADT) in n=420 patients with moderate/severe depression (PHQ-9>10), following a stepped wedge cluster randomized design in which 14 facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g. HIV: viral load, ART adherence; diabetes: A1C levels; hypertension: systolic blood pressure) will be measured every three months, inclusive of baseline, pre-treatment, post-treatment (3 months), 6- and 12 months follow-up. We will also evaluate the model's suitability for national scale-up from three perspectives: cost-effectiveness, feasibility and research capacity. Cost-effectiveness will examine direct treatment effects on depressive symptoms, as well as indirect benefits on (a) comorbid conditions, and (b) burden of care among household members of participants. Feasibility will be assessed through key informant interviews with n=20 study participants and n=10 providers. Research capacity will be supported through (i) a university course and field placement instituted in Years 3-5, (ii) a local research mentorship program, and (iii) a training protocol on the depression care package, inclusive of evaluation tools, for national dissemination launched in Year 5.