Evaluating the delivery of Problem Management Plus in primary care settings in rural Rwanda: a study protocol using a pragmatic randomised hybrid type 1 effectiveness-implementation design.

Introduction: Evidence-based low-intensity psychological interventions such as Problem Management Plus (PM+) have the potential to expand treatment access for depression and anxiety, yet these interventions are not yet effectively implemented in rural, public health systems in resource-limited settings. In 2017, Partners In Health adapted PM+ for delivery by primary care nurses in rural Rwanda and began integrating PM+ into health centres in collaboration with the Rwandan Ministry of Health, using established implementation strategies for mental health integration into primary care (Mentoring and Enhanced Supervision at Health Centers for Mental Health (MESH MH)). A gap in the evidence regarding whether low-intensity psychological interventions can be successfully integrated into real-world primary care settings and improve outcomes for common mental disorders remains. In this study, we will rigorously evaluate the delivery of PM+ by primary care nurses, supported by MESH MH, as it is scaled across one rural district in Rwanda.

Methods And Analysis: We will conduct a hybrid type 1 effectiveness-implementation study to test the clinical outcomes of routinely delivered PM+ and to describe the implementation of PM+ at health centres. To study the clinical effectiveness of PM+, we will use a pragmatic, randomised multiple baseline design to determine whether participants experience improvement in depression symptoms (measured by the Patient Health Questionnaire-9) and functioning (measured by the WHO-Disability Assessment Scale Brief 2.0) after receiving PM+. We will employ quantitative and qualitative methods to describe and evaluate PM+ implementation outcomes using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework, using routinely collected programme data and semistructured interviews.

Ethics And Dissemination: This evaluation was approved by the Rwanda National Ethics Committee (Protocol #196/RNEC/2019) and deemed exempt by the Harvard University Institutional Review Board. The results from this evaluation will be useful for health systems planners and policy-makers working to translate the evidence base for low-intensity psychological interventions into practice.