Trust but verify: Is there a role for active surveillance in monitoring adverse events in Zimbabwe’s large-scale male circumcision program?

Introduction: Ensuring quality service provision is fundamental to ZAZIC’s voluntary medical male circumcision (MC) program in Zimbabwe. From October, 2014 to September, 2017, ZAZIC conducted 205,847 MCs. Passive surveillance recorded a combined moderate and severe adverse event (AE) rate of 0.3%; reported adherence to follow-up was 95%, suggesting program safety. Despite encouraging passive surveillance data, verification of data quality and accuracy would increase confidence in AE identification. Methods: From May to August, 2017, ZAZIC implemented a focused quality assurance (QA) study on AE ascertainment and documentation at 6 purposively-selected, high-volume MC sites. ZAZIC Gold-Standard (GS) clinicians prospectively observed 100 post-MC follow-ups per site in tandem with facility-based MC providers to confirm and characterize AEs, providing mentoring in AE management when needed. GS clinicians also retrospectively reviewed site-based, routine MC data, comparing recorded to reported AEs, and held brief qualitative interviews with site leadership on AE-related issues. Results: Observed AE rates varied from 1–8%, potentially translating to thousands of unidentified AEs if observed AE rates were applied to previous MC performance. Most observed AEs were infections among younger clients. Retrospective review found discrepancies in AE documentation and reporting. Interviews suggest human resource and transport issues challenge MC follow-up visit attendance. Post-operative self-care appears to produce generally good results for adults; however, younger clients and guardians need additional attention to ensure quality care. There was no evidence of missed severe AEs resulting in permanent impairment or morbidity. Conclusions: Although results cannot be generalized, active surveillance suggests that AEs may be higher and follow-up lower than reported. In response, ZAZIC’s Quality Assurance Task Force will replicate this QA study in other sites; increase training in AE identification, management, and documentation for clinical and data teams; and improve post-operative counseling for younger clients. Additional nurses and vehicles, especially in rural health clinics, could be beneficial.