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

项目总结 这项提案汇集了来自美国和美国顶尖国家的精神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(MOH)，以评估有效性和 纳入马拉维抑郁症护理的循证阶梯模型的成本效益 全国艾滋病防治平台。马拉维的艾滋病毒感染率在世界上排名第九，人均国内生产总值排名第二 人均收入。此外，抑郁症是导致残疾的主要原因，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。在此背景下，一个重大成功 扩大了由709家艾滋病毒诊所组成的网络，有50多万患者参加了抗逆转录病毒治疗。作为一名 拥有专门的人力资源和基础设施的慢性护理系统，这为 整合抑郁症护理，并回应强大的证据基础概述的双向 抑郁症和艾滋病毒的后果。研究小组的成员已经成功地在 邻近地区，证明了可行性、可接受性和初步效果。此外，该团队已经 已经将高血压和糖尿病等其他非传染性疾病的治疗纳入 马拉维Neno区的艾滋病毒护理系统。此外，团队成员还成功地将抑郁症 将护理纳入类似环境的艾滋病毒服务(乌干达)，并建立了抑郁症护理模式，如Problem 解决疗法(PST)在整个撒哈拉以南非洲的环境中，除了在 马拉维的抑郁症患病率、筛查和诊断工具。在此基础上，我们将评估一枚金牌 将基于群体的PST与抗抑郁治疗相结合的抑郁症护理的标准阶梯式模式 (ADT)420例中/重度抑郁症患者(PHQ-9和GT；10)，遵循阶梯状楔形簇 随机化设计，其中14个设施被随机化，在15个月内分五步实施该模型 句号。主要结果(抑郁症状、功能障碍和总体健康)和次要结果 结果(例如，艾滋病毒：病毒载量，抗逆转录病毒疗法的依从性；糖尿病：糖化血红蛋白水平；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。我们还将从三个角度评估该模型是否适合在全国范围内推广： 成本效益、可行性和研究能力。成本效益将审查直接治疗对 抑郁症状，以及(A)共病和(B)护理负担的间接益处 参与者的家庭成员。可行性将通过与关键线人的面谈进行评估，n=20 研究参与者和n=10个提供者。研究能力将通过(I)大学课程和 在3-5年制定的实地安置；(2)当地研究指导方案；(3)关于以下方面的培训方案 抑郁症护理一揽子计划，包括评估工具，于第5年开始在全国范围内传播。

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.