Evaluating the impact of a community health worker program on non-communicable disease, malnutrition, tuberculosis, family planning and antenatal care in Neno, Malawi : protocol for a stepped-wedge, cluster randomized controlled trial

Introduction: This protocol concerns the implementation and evaluation of an intervention designed to realign the existing cadre of Community Health Workers (CHWs) in Neno District, Malawi to better support the care needs of the clients they serve. The proposed intervention is a ‘Household Model’ where CHWs will be reassigned to households, rather than to specific patients with HIV and/or TB. Methods and Analysis: Using a stepped-wedge, cluster-randomized design, this study investigates whether high HIV retention rates can be replicated for non-communicable diseases (NCDs), and the Model’s impact on TB and pediatric malnutrition case-finding, as well as the uptake of family planning and antenatal care. Eleven sites (health centres and hospitals) were arranged into six clusters (average cluster population 21,800). Primary outcomes include retention in care for HIV and chronic NCDs, TB case finding, pediatric malnutrition case finding, and utilization of early and complete antenatal. Clinical outcomes are based on routinely collected data the Ministry of Health’s District Health Information System 2 and an OpenMRS Electronic Medical Record supported by Partners In Health. Additionally, semi-structured qualitative interviews with various stakeholders will assess community perceptions and context of the Household Model. Ethics and dissemination: Ethics approval has been obtained from the Malawian National Health Science Research Committee (#16/11/1694) in Lilongwe, Malawi; Partners Healthcare Human Research Committee (#2017P000548/PHS) in Somerville, Massachusetts; and by the Biomedical and Scientific Research Ethics Sub-Committee (REGO-2017-2060) at the University of Warwick in Coventry, United Kingdom. Dissemination will include manuscripts for peer-reviewed publication as well as a full report detailing the findings of the intervention for the Malawian Ministry of Health. Registration: Registered on ClinicalTrials.gov in April 2017. Identifier: NCT0310672