Improving mycetoma case detection through the training of community health workers in Northern Uganda: protocol for a stepped-wedge cluster-randomized trial

Abstract

Introduction: The World Health Organization acknowledges the need for countries to incorporate neglected tropical disease care into their routine health care system. However, low detection rates and late presentation of mycetoma to health facilities have been observed in endemic countries, including Uganda. Objective: To empower community health workers (CHWs) in Northern Uganda to recognize and refer suspects of mycetoma to health facilities. Design: This will be a stepped-wedge cluster-randomized trial based in Gulu and Pader districts over a period of 9 months with sequential crossover from intervention phase to the control phase at different time points until both districts are exposed to the intervention. Methods and Analysis: The study will leverage on the ongoing partnership between Northern Uganda Medical Mission and the Uganda Ministry of Health that has trained over 300 CHWs in Gulu and Pader. The study evaluation will be done using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. The expected outcome of the study is increased detection and referral of suspects of mycetoma. Data will be analyzed using STATA 17.0 and Friedman statistics or Analysis of Variance to determine increase in case identifications and referrals. Ethics and Registration: The study was approved by Mulago Hospital Research and Ethics Committee (MHREC 2406) and registered with Pan African Clinical Trial Registry (PACTR202301534749787). Dissemination: The results from this trial will be published in a peer-reviewed journal. In addition, the findings will be shared at conferences, with funders, and at other research meetings.