The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity-Building Scale-Up Trial: Study Design and Protocol.

BACKGROUND: Depression is a leading cause of death and disability worldwide, including in low- and middle-income countries (LMICs). Depression often coexists with chronic medical conditions and is associated with worse clinical outcomes. This confluence has led to calls to integrate mental health treatment with chronic disease care systems in LMICs. This article describes the rationale and protocol for a trial comparing the clinical effectiveness and cost-effectiveness of two different intervention packages to implement evidence-based antidepressant management and psychotherapy into chronic noncommunicable disease (NCD) clinics in Malawi. METHODS: Using constrained randomization, the Sub-Saharan Africa Regional Partnership (SHARP) for mental health capacity building will assign five Malawian NCD clinics to a basic implementation strategy via an internal coordinator, a provider within the chronic care clinic who champions depression services by providing training, supervision, operations, and reporting. Another five clinics will be assigned to depression services implementation via an internal coordinator along with an external quality assurance committee, which will provide a quarterly audit of intervention component delivery with feedback to providers and the health management team. RESULTS: The authors will compare key implementation outcomes (fidelity to intervention), clinical effectiveness outcomes (patient health), and cost-effectiveness and will assess characteristics of clinics that may influence uptake and fidelity. NEXT STEPS: This trial will provide key information to guide the Malawi Ministry of Health in scaling up depression management in existing NCD settings. The SHARP trial is anticipated to substantially contribute to enhancing both mental health treatment and implementation science research capacity in Malawi and the wider region.