Integrating a Stepped Care Model of Screening and Treatment for Depression Into Malawi's National HIV Care Delivery Platform - Trial NCT04777006

Timeline & Enrollment

Primary Outcome

Depression symptoms, 3 months,Depression symptoms, 6 months,Depression symptoms, 9 months,Depression symptoms, 12 months,Functional impairment, 3 months,Functional impairment, 6 months,Functional impairment, 9 months,Functional impairment, 12 months,Overall health profile, 3 months,Overall health profile, 6 months,Overall health profile, 9 months,Overall health profile, 12 months,Depression prevalence, 3 months,Depression prevalence, 6 months,Depression prevalence, 9 months,Depression prevalence, 12 months

Summary

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. 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 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.
 
 The investigators 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). Rollout 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 three months through 12-month follow-up. The investigators 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. The investigators will also
 look at the indirect effects of the intervention at the household level. The investigators'
 hypothesis is that the intervention will be effective at reducing depression symptoms,
 improving physical health, and improving household members' wellbeing, compare to treatment
 as usual. The investigators also hypothesize that the intervention will be highly
 cost-effective, meaning that the cost per QALY gained will be less than Malawi's median GDP
 per capita. If determined to be effective and 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.

ICD-10 Classifications