Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease—including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. The lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in antiretroviral therapy (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. We will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9) and Mini-International Neuropsychiatric Interview (MINI). Roll-out will follow a stepped-wedge cluster randomized design in which 14 health 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, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every 3 months through 12-month follow-up. We will also evaluate the model’s cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model. This study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. If determined to be cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence. ClinicalTrials.gov NCT04777006 . Registered on 1 March, 2021

中文翻译：

---

马拉维综合慢性病护理中心 (IC3) 的抑郁症分级护理：阶梯楔形集群随机对照试验的研究方案

马拉维是撒哈拉以南非洲的一个低收入国家，其资源有限，无法解决包括艾滋病毒/艾滋病在内的重大疾病负担。此外，抑郁症是该国残疾的主要原因，但很大程度上仍未得到诊断和治疗。缺乏具有成本效益、可扩展的解决方案是扩大抑郁症治疗的根本障碍。在此背景下，一项重大成功是扩大了由 700 多家艾滋病毒诊所组成的网络，超过 50 万患者参加了抗逆转录病毒治疗 (ART)。作为一个拥有专门人力资源和基础设施的长期护理系统，这提供了一个整合抑郁症护理的战略平台，并响应概述抑郁症和艾滋病毒结果双向性的强有力的证据基础。我们将评估马拉维尼诺区 420 名中度/重度抑郁症成年人的抑郁症护理阶梯模式，该模式将基于小组的问题管理升级版（PM+ 组）与抗抑郁治疗 (ADT) 相结合，并通过患者健康问卷 9 进行测量(PHQ-9) 和小型国际神经精神病学访谈 (MINI)。推出将遵循阶梯式楔形集群随机设计，其中 14 个卫生机构被随机分配，在 15 个月的时间内分五个步骤实施该模型。主要结局（抑郁症状、功能障碍和整体健康）和次要结局（例如，HIV：病毒载量、ART 依从性；糖尿病：A1C 水平、治疗依从性；高血压：收缩压、治疗依从性）将每 3 个月测量一次通过12个月的随访。我们还将评估该模型的成本效益，量化为与没有干预模型的情况下的基线慢性护理服务相比的增量成本效益比（ICER）。这项研究将进行一项阶梯楔形整群随机试验，以比较基于证据的抑郁症护理模式与常规护理对抑郁症症状补救以及慢性护理状况的身体健康结果的影响。如果确定具有成本效益，这项研究将为将抑郁症护理纳入马拉维其他地区和其他艾滋病毒感染率高的资源匮乏地区的艾滋病毒诊所提供一个模型。ClinicalTrials.gov NCT04777006。注册日期：2021年3月1日