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.
Age range
18 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Depression Symptoms (PHQ-9), 3 Months Post-intervention for All Participants (i.e., for Each Arm)
Timeframe: 3 months post-intervention for all participants (i.e., for each arm)
Depression Symptoms (PHQ-9), 6 Months Post-intervention for All Participants (i.e., for Each Arm)
Timeframe: 6 months post-intervention for all participants (i.e., for each arm)
Depression Symptoms (PHQ-9), 9 Months Post-intervention for All Participants (i.e., for Each Arm)
Timeframe: 9 months post-intervention for all participants (i.e., for each arm)
Depression Symptoms (PHQ-9), 12 Months Post-intervention for All Participants (i.e., for Each Arm).
Timeframe: 12 months post-intervention for all participants (i.e., for each arm).
Functional Impairment (WHO Disability Assessment Schedule), 3 Months Post-intervention for All Participants (i.e., for Each Arm).
Timeframe: 3 months post-intervention for all participants (i.e., for each arm).
Functional Impairment (WHO Disability Assessment Schedule), 6 Months Post-intervention for All Participants (i.e., for Each Arm).
Timeframe: 6 months post-intervention for all participants (i.e., for each arm).
Functional Impairment (WHO Disability Assessment Schedule), 9 Months Post-intervention for All Participants (i.e., for Each Arm).
Timeframe: 9 months post-intervention for all participants (i.e., for each arm).
Functional Impairment (WHO Disability Assessment Schedule), 12 Months Post-intervention for All Participants (i.e., for Each Arm).
Timeframe: 12 months post-intervention for all participants (i.e., for each arm).
Overall Health Profile (EQ-5D-5L), 3 Months Post-intervention for All Participants (i.e., for Each Arm).
Timeframe: 3 months post-intervention for all participants (i.e., for each arm).
Overall Health Profile (EQ-5D-5L), 6 Months Post-intervention for All Participants (i.e., for Each Arm).
Timeframe: 6 months post-intervention for all participants (i.e., for each arm).
Overall Health Profile, 9 Months Post-intervention for All Participants (i.e., for Each Arm).
Timeframe: 9 months post-intervention for all participants (i.e., for each arm).
Overall Health Profile, 12 Months Post-intervention for All Participants (i.e., for Each Arm).
Timeframe: 12 months post-intervention for all participants (i.e., for each arm).
Prevalence of Depression (PHQ-9 Score > 9), 3-months Post-intervention for All Participants (for Each Arm).
Timeframe: 3 months post-intervention for all participants (for each arm).
Prevalence of Depression (PHQ-9 Score > 9), 6-months Post-intervention for All Participants (for Each Arm).
Timeframe: 6 months post-intervention for all participants (for each arm).
Prevalence of Depression (PHQ-9 Score > 9), 9-months Post-intervention for All Participants (for Each Arm).
Timeframe: 9 months post-intervention for all participants (for each arm).
Prevalence of Depression (PHQ-9 Score > 9), 12-months Post-intervention for All Participants (for Each Arm).
Timeframe: 12 months post-intervention for all participants (for each arm).