Protocol for the MIND-DZ Trial: Integrating Mental Health Screening and Management into Chronic Care for Patients with HIV and Diabetes in Zimbabwe

This protocol outlines the MIND-DZ Trial, a cluster-randomised controlled trial designed to evaluate an integrated care model for comorbid depression and anxiety in patients with both HIV and type 2 diabetes in Zimbabwe. The high prevalence of these mental health conditions, which exacerbate clinical outcomes for both chronic diseases, is currently unaddressed in routine primary care. Twenty-four clinics in Harare will be randomised to either the intervention or a standard-care control arm. The evidence-based intervention, developed through prior formative research, incorporates a validated mental health screening tool and a manualised stepped-care protocol. This protocol includes task-shifted, non-specialist delivered psychological support and structured referral pathways, fully integrated into existing chronic care consultations. Control clinics will continue providing unenhanced standard care. Over 18 months, the trial will enrol 480 participants. The primary outcome is the reduction of composite mental health symptoms at six-month follow-up. Key secondary outcomes include biomedical indicators (HIV viral suppression and glycaemic control) and patient-reported quality of life. Process evaluation will assess implementation fidelity and feasibility. As one of the first trials of its kind in the region, MIND-DZ addresses a critical evidence gap on scalable, task-shifted integration models within African public health systems. Results, anticipated in mid-2026, will provide rigorous evidence to inform policy on integrating mental healthcare into chronic disease programmes in low-resource settings.