Community-based scale of integrated community health worker-led cardiovascular risk factor management (ComBaScale)

ComBaScale aims to empower community health workers (CHWs) in under-resourced settings to deliver a high-quality, evidence-based, holistic package of integrated care for cardiovascular risk factors (CVRF). Its scalability will be tested in two districts of Lesotho, a low-income country disproportionately affected by a rising burden of non-communicable diseases (NCDs).

Guided by a validated implementation framework, trial evidence on the safety and effectiveness of CHW-led titration of antihypertensive and antidiabetic therapy will be translated into practice, while embedded in the national system. A pilot study will refine the intervention and align it with CHWs’ routine responsibilities, including HIV and tuberculosis screening, before roll-out through a stepped-wedge cluster randomised trial with a hybrid effectiveness-implementation design.

The CHWs will be supported by a patient-facing clinical decision-support application, interoperable with the national information system and featuring an innovative authoring tool to ensure safety and guideline fidelity. The trial will include an equity-informative extended cost-effectiveness analysis, while mixed-methods will examine acceptability, stigma, and gender-related barriers.

People living with CVRF will play a central role in co-developing and monitoring the intervention via community advisory boards, alongside village authorities, implementing partners, and researchers. All trial results, implementation frameworks, training material, and digital tools will be compiled in a comprehensive toolkit and piloted in a separate district for further scale-up. By applying the principles of implementation science throughout, ComBaScale will generate a validated, co-created, integrated CVRF care package, ready for adaptation across Lesotho and other under-resourced populations to reduce the NCD burden globally.