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Published in: Current HIV/AIDS Reports 6/2022

Open Access 08-11-2022 | Circumcision | Voluntary Medical Male Circumcision: Progress and Challenges (S Vermund, Section Editor)

Consolidated Overview of Notifiable Adverse Events in the U.S. President’s Emergency Plan for AIDS Relief’s Voluntary Medical Male Circumcision Program Through 2020

Authors: Todd Lucas, Caroline Cooney, Amber Prainito, Catherine Godfrey, Valerian Kiggundu, Anne Goldzier Thomas, Renee Ridzon, Carlos Toledo

Published in: Current HIV/AIDS Reports | Issue 6/2022

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Abstract

Purpose of Review

Through December 2020, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) supported more than 25 million voluntary medical male circumcisions (VMMC) as part of the combined HIV prevention strategy in 15 African countries. PEPFAR monitors defined adverse events (AEs) occurring within 30 days of VMMC through its notifiable adverse event reporting system (NAERS). All NAERS reports through December 2020 were reviewed to quantify AE type, severity, and relation to the VMMC procedure. Interventions to improve client safety based on NAERS findings are described.

Recent Findings

Fourteen countries reported 446 clients with notifiable adverse events (NAEs); 394/446 (88%) were determined VMMC-related, representing approximately 18 NAE reports per million circumcisions. Fatalities comprised 56/446 (13%) with 24/56 (43%) of fatalities determined VMMC-related, representing 0.96 VMMC-related fatalities per million circumcisions. The remaining 390 NAEs were non-fatal with 370/390 (95%) VMMC-related. Multiple programmatic changes have been made based on NAERS data to improve client safety.

Summary

Client safety is paramount in this surgical program designed for individual and population-level benefit. Surveillance of rare but severe complications following circumcision has identified pre-existing or new safety concerns and guided continuous programmatic improvement.
Footnotes
1
Displacement of circumcision device (when a device intended to remain in place comes loose prior to the intended removal date) was added as an NAE in October 2020 if the AE severity was determined to be moderate or severe; the others have been designated NAEs since Jan 2015.
 
2
A small volume of device circumcisions in 13–14-year-old clients are supported by PEPFAR when accompanied by enhanced safety monitoring.
 
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Metadata
Title
Consolidated Overview of Notifiable Adverse Events in the U.S. President’s Emergency Plan for AIDS Relief’s Voluntary Medical Male Circumcision Program Through 2020
Authors
Todd Lucas
Caroline Cooney
Amber Prainito
Catherine Godfrey
Valerian Kiggundu
Anne Goldzier Thomas
Renee Ridzon
Carlos Toledo
Publication date
08-11-2022
Publisher
Springer US
Published in
Current HIV/AIDS Reports / Issue 6/2022
Print ISSN: 1548-3568
Electronic ISSN: 1548-3576
DOI
https://doi.org/10.1007/s11904-022-00636-8

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