RAND Corporation, Boston, 20 Park Plz, Boston, MA, 02116, USA.
Partners In Health, Boston, MA, USA.
Trials. 2021 Sep 16;22(1):630. doi: 10.1186/s13063-021-05601-1.
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.
马拉维是撒哈拉以南非洲的一个低收入国家，资源有限，难以应对包括艾滋病毒/艾滋病在内的重大疾病负担。此外，抑郁症是该国导致残疾的主要原因，但大部分患者未得到诊断和治疗。缺乏具有成本效益且可扩展的解决方案是扩大抑郁症治疗的一个基本障碍。在此背景下，一个主要的成功案例是一个拥有 700 多家艾滋病诊所的网络的扩大，该网络为超过 50 万名接受抗逆转录病毒疗法 (ART) 的患者提供服务。作为一个拥有专门人力资源和基础设施的慢性病护理系统，这为整合抑郁症护理提供了一个战略平台，并回应了一个强有力的证据基础，该证据基础概述了抑郁症和艾滋病毒结果之间的双向关系。
我们将评估一种基于群组的问题管理加（group PM+）与抗抑郁治疗（ADT）相结合的抑郁症护理递进模型，在马拉维恩诺区，该模型将针对 420 名中度/重度抑郁症患者（用患者健康问卷-9（PHQ-9）和迷你国际神经精神访谈（MINI）进行评估）进行评估。该模型将采用逐步楔形集群随机设计实施，在 15 个月内，14 个卫生设施将被随机分为五个步骤实施该模型。主要结局（抑郁症症状、功能障碍和总体健康）和次要结局（如艾滋病毒：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）将通过 12 个月的随访，每 3 个月测量一次。我们还将评估该模型的成本效益，与干预模型不存在的情况下的基线慢性护理服务相比，用增量成本效益比（ICER）来量化。
本研究将开展一项逐步楔形集群随机试验，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缓解以及慢性护理条件下的身体健康结果的影响。如果被确定为具有成本效益，本研究将为在马拉维和其他艾滋病毒流行率高的资源有限的地区将抑郁症护理纳入艾滋病毒诊所提供一个模式。
ClinicalTrials.gov NCT04777006。于 2021 年 3 月 1 日注册。
