Implementation of a co-created multimodal strategy to improve infection prevention and control in Malawian hospitals: A mixed-methods study protocol

Background Healthcare associated infections (HAIs) remain a major patient safety concern in low-income settings where implementation of infection prevention and control (IPC) measures is not consistent. Despite the availability of the national IPC guidelines in Malawi, gaps persist in their translation into routine clinical practice. This study protocol describes the planned implementation and evaluation of a co-created multifaceted IPC intervention in two tertiary hospitals. Methods We will conduct a mixed-methods implementation research study guided by the Exploration, Preparation, Implementation and Sustainment (EPIS) framework. The intervention is informed by the World Health Organization multimodal improvement strategy and has three components: (1) system change, including revision of IPC standard operating procedures, provision of essential IPC resources and strengthening leadership and governance; (2) capacity building through training of healthcare workers and IPC champions, alongside patient and patient-guardian education; and (3) quality improvement through work improvement teams (WITs) using standard based audit and feedback. The intervention will be implemented over 18 months in medical and surgical wards in two tertiary hospitals in Malawi. Evaluation will include three interrelated sub-studies: knowledge and practice change; system and outcome evaluation; and process evaluation assessing fidelity, dose, reach, acceptability and contextual determinants affecting implementation. Data collection will include structured observations, surveys, interviews, focus group discussions and ward assessments of IPC practices. Conclusion This study will generate context-specific evidence on the implementation of co-created IPC strategies in a low-resource setting. Findings will inform the development of a scalable IPC implementation toolkit and support efforts to improve IPC practices and reduce HAIs in Malawi and similar settings.