ABSTRACT Task-shared mental health interventions are effective in low- and middle-income countries, yet they remain underutilized and the mental health treatment gap remains substantial. Innovative implementation strategies are needed to successfully integrate evidence-based mental health treatments into medical care in LMICs. A common component of many implementation efforts is a “champion” strategy which identifies and empowers an on-the-ground staff member as the implementation champion, in charge of focusing their colleagues’ efforts on implementation of the evidence-based treatment model. Yet a growing body of research, including our own work in Malawi and elsewhere, highlights that the champion’s success is strongly influenced by the strength of support from their line manager and other up-the-chain organization leaders, who are critical in aligning the organization’s climate and priorities in support of the implementation effort. Approaches to influencing leadership engagement to change organizational climate and align priorities has been developed over decades in the field of organizational and industrial psychology but only relatively recently applied to implementation science health research and primarily to implementation in high-income countries. The Leadership and Organizational Change for Implementation (LOCI) is a recently developed multi-level leadership coaching implementation strategy that has demonstrated effectiveness in changing organizational climate, aligning priorities, and enhancing mental health treatment model integration in the US and Norway, but has not been adapted to or tested in low-income country settings. LOCI has significant potential to address the gaps identified in our current research by aligning leadership priorities to support champions in advancing mental health integration. The objective of the present proposal is to test the impact and sustainability of supplementing the standard champion implementation approach with the LOCI leadership alignment strategy to achieve successful integration of an evidence-based, task-shared mental health treatment model into general medical care. We will use a cluster-randomized trial to evaluate the impact of the adapted leadership alignment strategy on integration of an evidence-based mental health treatment package into multiple medical care settings (NCD, HIV, and TB care), assessing proximal (climate), primary implementation (adoption, reach, fidelity), downstream patient mental health, and cost-effectiveness outcomes as well as sustainability after conclusion of the leadership alignment activities. Additionally, we will use the structure of the research project to further strengthen capacity among mental health researchers and policy makers in Malawi. Leadership alignment strategies are an understudied but essential ingredient for successful mental health integration efforts. This project will make a major contribution to our understanding of the role of leadership alignment in advancing evidence-based mental health integration in LMICs.

PROJECT NARRATIVE The overall objective of this proposal is to test, using a cluster-randomized RCT, the impact and sustainability of a health system leadership alignment strategy to achieve successful integration of an evidence-based, task-shared mental health treatment model into general medical care in Malawi. Leadership alignment is an essential ingredient for successful mental health integration but has received extremely limited attention in low and middle income countries. This project will make a major contribution to our understanding of the role of leadership alignment in advancing evidence-based mental health integration.