Title

ZAZIC consortium at 10 years: do mature voluntary medical male circumcision programs maintain client safety?

Presenter

Vongai Museza

Authors

V. Museza¹, L.C.T. Masimba², F. Gwenzi³, J. Gavhera⁴, B.C. Makunike⁵, P. Gonouya⁵, M.M. Holec⁶, S. Barnhart⁷, C. Feldacker⁸, S. Xaba⁹, T. Madoda¹⁰

Institutions

¹Africa University, Health Sciences, Mutare, Zimbabwe, ²Africa University, Social Sciences, Mutare, Zimbabwe, ³Midlands Sta, Social Sciences, Gweru, Zimbabwe, ⁴Midlands State University, Development Studies, Harare, Zimbabwe, ⁵University of Zimbabwe, Medicine, Harare, Zimbabwe, ⁶University of Washington, Global Health, Seattle, United States, ⁷University of Washington, Public Health and Community Medicine, Seattle, United States, ⁸University of North Carolina, Public Health, Wilmington, United States, ⁹National University Of Science and Technology, Development Studies, Bulawayo, Zimbabwe, ¹⁰Zimbabwe Open University, Nursing Sciences, Harare, Zimbabwe

BACKGROUND: Voluntary Medical Male Circumcision (VMMC) for HIV prevention reached over 29 million males in 15 countries in Eastern and Southern Africa by 2022. VMMC is safe with reported adverse events (AE) rates of <1% from routine programs at scale. However, AE rates of 2% are expected within high quality VMMC programs, indicating that complications are identified, managed, and treated. Prior studies suggest that reliance on passive surveillance alone is insufficient. The ZAZIC consortium in Zimbabwe employed active AE surveillance to help ensure client safety.
DESCRIPTION: ZAZIC proactively identifies, treats, and manages AEs as part of routine quality assurance (QA) efforts. From October 2021 to March 2023, ZAZIC implemented three additional approaches for AE surveillance. First, as part of productivity verification, ZAZIC contacted VMMC clients via phone or home visit to assess VMMC status and complications. Across 17 sites (412 males), one additional severe AE (bleeding) was identified for an AE rate of 0.24%. Second, tandem reviews paired an expert ZAZIC clinician with a site-based clinician to jointly conduct post-operative visits 7 days post VMMC. Across four sites, 41 clients were reviewed with no AEs reported. Third, ZAZIC implemented two-way texting (2wT) follow-up for VMMC clients with mobile phones, communicating over the first 14 post-operative days. Among the 31,000 males followed-up by 2wT, 0.04% had a documented AE.

LESSONS LEARNED: ZAZIC employs multiple QA approaches for AE identification across its national program, including verification, tandem reviews, and 2wT. These routine interventions serve as a proxy for AE active surveillance, strongly suggesting a safe VMMC program. However, continued low ascertainment of AEs, with observed AE rates below the expected 2% threshold, suggests that additional ZAZIC vigilance is warranted. Although costly, increased investment to ensure safety of VMMC services are essential for safe services.

CONCLUSIONS: Given the continued low reported AE rates, it is important to maintain investment in rigorous program evaluation, including QA activities and active AE surveillance, to ensure VMMC program safety. With follow-up rates less than 100%, and the limitations of passive surveillance for AEs, combinations of active surveillance activities should be required for VMMC programs at scale.

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