PMID- 34403409
OWN - NLM
STAT- MEDLINE
DCOM- 20211123
LR  - 20240404
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 16
IP  - 8
DP  - 2021
TI  - Description of adverse events among adult men following voluntary medical male 
      circumcision: Findings from a circumcision programme in two provinces of South 
      Africa.
PG  - e0253960
LID - 10.1371/journal.pone.0253960 [doi]
LID - e0253960
AB  - BACKGROUND: Clinical trials showed strong evidence that voluntary medical male 
      circumcision (VMMC) reduces the acquisition of HIV among heterosexual men by up 
      to 60%. However, VMMC uptake in East and Southern Africa remains suboptimal, with 
      safety concerns identified as a barrier to uptake. We investigated the occurrence 
      and severity of adverse events (AEs) in a routine VMMC programme implemented in 
      Gauteng and North West provinces of South Africa. METHODS: We describe the 
      frequency and characteristics of AEs using routinely collected data from a VMMC 
      programme implemented between 01 May 2013 and 31 December 2014. The surgical 
      procedure was provided at fixed clinics and mobile units in three districts. 
      Adult men undertaking the procedure were referred for follow-up appointments 
      where AEs were monitored. RESULTS: A total of 7,963 adult men were offered the 
      VMMC service with 7,864 (98.8%) met the age and consent requirements for 
      inclusion in a research follow-up after the surgical procedure and were 
      followed-up for potential AEs. In total, 37 (0.5%) patients reported AEs 
      post-surgery with infection [11 (29.7%)] and excessive bleeding [11 (29.7%)] 
      commonly reported AEs. In terms of severity, 14 (37.8%) were classified as mild, 
      13 (35.1%) as moderate, and 10 (27.0%) as severe. Further, 32 (86.5%) of the AEs 
      were classified as definitely related to the surgical procedure, with 36 (97.5%) 
      of all AEs resolving without sequelae. CONCLUSION: The VMMC programme was able to 
      reach adult men at high risk of HIV acquisition. Reported AEs in the programme 
      were minimal, with the observed safety profile comparable to clinical trial 
      settings, suggesting that VMMC can be safely administered in a programmatic 
      setting.
FAU - Muchiri, Evans
AU  - Muchiri E
AUID- ORCID: 0000-0003-4642-2674
AD  - The Aurum Institute, Johannesburg, South Africa.
FAU - Charalambous, Salome
AU  - Charalambous S
AD  - The Aurum Institute, Johannesburg, South Africa.
AD  - School of Public Health, University of the Witwatersrand, Johannesburg, South 
      Africa.
FAU - Ginindza, Sibuse
AU  - Ginindza S
AD  - The Aurum Institute, Johannesburg, South Africa.
FAU - Maraisane, Mpho
AU  - Maraisane M
AD  - The Aurum Institute, Johannesburg, South Africa.
FAU - Maringa, Tintswalo
AU  - Maringa T
AD  - CDC South Africa, Pretoria, South Africa.
FAU - Vranken, Peter
AU  - Vranken P
AD  - CDC South Africa, Pretoria, South Africa.
FAU - Loykissoonlal, Dayanund
AU  - Loykissoonlal D
AD  - National Department of Health, Johannesburg, South Africa.
FAU - Muturi-Kioi, Vincent
AU  - Muturi-Kioi V
AUID- ORCID: 0000-0003-1620-3999
AD  - International AIDS Vaccine Initiative (IAVI), Nairobi, Kenya.
FAU - Chetty-Makkan, Candice M
AU  - Chetty-Makkan CM
AD  - The Aurum Institute, Johannesburg, South Africa.
AD  - School of Public Health, University of the Witwatersrand, Johannesburg, South 
      Africa.
LA  - eng
GR  - U01 GH000522/GH/CGH CDC HHS/United States
GR  - PEPFAR/PEPFAR/United States
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20210817
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Africa, Southern/epidemiology
MH  - Circumcision, Male/*adverse effects
MH  - Follow-Up Studies
MH  - HIV Infections/prevention & control
MH  - HIV-1
MH  - Humans
MH  - *Infections/epidemiology/etiology
MH  - Male
MH  - Middle Aged
MH  - Postoperative Hemorrhage/*epidemiology
MH  - Retrospective Studies
MH  - South Africa
MH  - *Voluntary Programs
PMC - PMC8370616
COIS- The authors have declared that no competing interests exist.
EDAT- 2021/08/18 06:00
MHDA- 2021/11/24 06:00
PMCR- 2021/08/17
CRDT- 2021/08/17 17:15
PHST- 2020/08/17 00:00 [received]
PHST- 2021/06/16 00:00 [accepted]
PHST- 2021/08/17 17:15 [entrez]
PHST- 2021/08/18 06:00 [pubmed]
PHST- 2021/11/24 06:00 [medline]
PHST- 2021/08/17 00:00 [pmc-release]
AID - PONE-D-20-25732 [pii]
AID - 10.1371/journal.pone.0253960 [doi]
PST - epublish
SO  - PLoS One. 2021 Aug 17;16(8):e0253960. doi: 10.1371/journal.pone.0253960. 
      eCollection 2021.