PMID- 36348185 OWN - NLM STAT- MEDLINE DCOM- 20221220 LR - 20230129 IS - 1548-3576 (Electronic) IS - 1548-3568 (Print) IS - 1548-3568 (Linking) VI - 19 IP - 6 DP - 2022 Dec TI - 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. PG - 508-515 LID - 10.1007/s11904-022-00636-8 [doi] AB - 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. 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. CI - (c) 2022. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply. FAU - Lucas, Todd AU - Lucas T AUID- ORCID: 0000-0002-8785-1830 AD - U.S. Centers for Disease Control and Prevention, Division of Global HIV and TB, HIV Prevention Branch, Atlanta, GA, USA. tlucas@cdc.gov. FAU - Cooney, Caroline AU - Cooney C AD - U.S. Department of State, Office of the U.S. Global AIDS Coordinator and Health Diplomacy, Washington, DC, USA. FAU - Prainito, Amber AU - Prainito A AD - U.S. Department of State, Office of the U.S. Global AIDS Coordinator and Health Diplomacy, Washington, DC, USA. FAU - Godfrey, Catherine AU - Godfrey C AD - U.S. Department of State, Office of the U.S. Global AIDS Coordinator and Health Diplomacy, Washington, DC, USA. FAU - Kiggundu, Valerian AU - Kiggundu V AD - U.S. Agency for International Development, Global Health, Office of HIV/AIDS, Washington, DC, USA. FAU - Thomas, Anne Goldzier AU - Thomas AG AD - U.S. Department of Defense HIV/AIDS Prevention Program, Defense Health Agency, San Diego, CA, USA. FAU - Ridzon, Renee AU - Ridzon R AD - U.S. Department of State, Office of the U.S. Global AIDS Coordinator and Health Diplomacy, Washington, DC, USA. FAU - Toledo, Carlos AU - Toledo C AD - U.S. Centers for Disease Control and Prevention, Division of Global HIV and TB, HIV Prevention Branch, Atlanta, GA, USA. LA - eng PT - Journal Article PT - Review DEP - 20221108 PL - United States TA - Curr HIV/AIDS Rep JT - Current HIV/AIDS reports JID - 101235661 SB - IM MH - Male MH - Humans MH - *Circumcision, Male/adverse effects MH - *Acquired Immunodeficiency Syndrome MH - *HIV Infections/epidemiology MH - Voluntary Programs MH - Africa PMC - PMC9643893 OTO - NOTNLM OT - Adverse event OT - Complication OT - HIV prevention OT - Male circumcision COIS- The authors declare no competing interests. EDAT- 2022/11/09 06:00 MHDA- 2022/12/21 06:00 PMCR- 2022/11/08 CRDT- 2022/11/08 23:45 PHST- 2022/08/19 00:00 [accepted] PHST- 2022/11/09 06:00 [pubmed] PHST- 2022/12/21 06:00 [medline] PHST- 2022/11/08 23:45 [entrez] PHST- 2022/11/08 00:00 [pmc-release] AID - 10.1007/s11904-022-00636-8 [pii] AID - 636 [pii] AID - 10.1007/s11904-022-00636-8 [doi] PST - ppublish SO - Curr HIV/AIDS Rep. 2022 Dec;19(6):508-515. doi: 10.1007/s11904-022-00636-8. Epub 2022 Nov 8.