At a glance
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Integrating a Stepped Care Model of Screening and Treatment for Depression Into Malawi's National HIV Care Delivery Platform
In Brief
A Phase 4 clinical trial evaluating Problem Management Plus and Antidepressant Therapy for Depressive Disorder. Completed, enrolled 487 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Arm 1 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 3 of the trial
Arm 2 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 6 of the trial
Arm 3 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 9 of the trial
Arm 4 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 12 of the trial
Arm 5 represents a cluster of 2-3 clinics randomized to begin delivering the intervention at month 15 of the trial
Interventions
PM+ is a cognitive-behavioral intervention that trains recipients to improve their management of practical problems, and uses the term "problem management" rather than "problem solving" to emphasize that many problems encountered by individuals living in adverse circumstances may not be "solvable". The "plus" in PM+ underscores additional evidence-based behavioral strategies incorporated into the model, including: stress management strategies, behavioral activation, and social support strengthening. In total, PM+ comprises five sessions held once per week for 1.5. to 2.5 hours per session. The model has shown success in reducing depression symptoms in low-resource settings such as Nepal and Pakistan.4
Fluoxetine, a serotonin selective reuptake inhibitor (SSRI), and amitriptyline, a tricyclic antidepressant (TCA), are part of Malawi's national formulary. Neno District supply chain is supported by PIH, which reduces stock-outs relative to those observed in other Malawian settings. Fluoxetine is typically the first drug of choice because it is safer and better tolerated. Daily dose will commence at 20 mg of fluoxetine, or 25 mg of amitriptyline. At monthly follow-up visits, a dose increment or medication change may be considered based on measures of treatment response and side effects, using an Antidepressant Side Effect Checklist. This algorithm-based process will be repeated every other week until the patient is fully responding to treatment (PHQ-9 \< 5) for a period of three months. Dose escalations of more than one increment and medication changes will be reviewed with the doctor-in-charge. If on ADT at end of study, it will be sustained as part of usual care.