PMID- 28362066
OWN - NLM
STAT- MEDLINE
DCOM- 20170830
LR  - 20181202
IS  - 1758-2652 (Electronic)
IS  - 1758-2652 (Linking)
VI  - 19
IP  - 1
DP  - 2017 Feb 21
TI  - Adverse event profile of a mature voluntary medical male circumcision programme 
      performing PrePex and surgical procedures in Zimbabwe.
PG  - 21394
LID - 10.7448/IAS.20.1.21394 [doi]
LID - 21251
AB  - INTRODUCTION: The frequency of adverse events (AEs) is a widely used indicator of 
      voluntary medical male circumcision (VMMC) programme quality. Though over 11.7 
      million male circumcisions (MCs) have been performed, little published data 
      exists on the profile of AEs from mature, large-scale programmes. No published 
      data exists on routine implementation of PrePex, a device-based MC method. 
      METHODS: The ZAZIC Consortium began implementing VMMC in Zimbabwe in 2013, 
      supporting services at 36 facilities. Aggregate data on VMMC outputs are 
      collected monthly from each facility. Detailed forms are completed describing the 
      profile of each moderate and severe AE. Bivariate and multivariable analyses were 
      conducted using log-binomial regression models. RESULTS: From October 2014 
      through September 2015, 44,868 clients were circumcised with 156 clients 
      experiencing a moderate or severe AE. 96.2% of clients had a follow-up visit 
      within 14 days of their procedure. AEs were uncommon, with 0.3% (116/41,416) of 
      surgical and 1.2% (40/3,452) of PrePex clients experiencing a moderate or severe 
      AE. After adjusting for VMMC site, we found that PrePex was associated with a 
      3.29-fold (95% CI: 1.78-6.06) increased risk of experiencing an AE compared to 
      surgical procedures. Device displacements, when the PrePex device is 
      intentionally or accidentally dislodged during the 7-day placement period, 
      accounted for 70% of PrePex AEs. The majority of device displacements were 
      intentional self-removals. Overall, infection was the most common AE among VMMC 
      clients. Compared to clients aged 20 and above, clients aged 10-14 were 3.07-fold 
      (95% CI: 1.36-6.91) more likely to experience an infection and clients aged 15-19 
      were 1.80-fold (95% CI: 0.82-3.92) more likely to experience an infection, 
      adjusted for site. CONCLUSION: This exploratory analysis found that clients 
      receiving PrePex were more likely to experience an AE than surgical circumcision 
      clients. This is largely attributable to the occurrence of device displacements, 
      which require prompt access to corrective surgical MC procedures as part of their 
      clinical management. Most device displacements were self-removals which are 
      preventable if client behaviour could be modified through counselling 
      interventions. We also found that infection after MC is more common among younger 
      clients, who may benefit from additional counselling or increased parental 
      involvement.
FAU - Bochner, Aaron F
AU  - Bochner AF
AD  - International Training and Education Center for Health (I-TECH), Seattle, WA, 
      USA.
AD  - Department of Epidemiology, University of Washington, Seattle, WA, USA.
FAU - Feldacker, Caryl
AU  - Feldacker C
AD  - International Training and Education Center for Health (I-TECH), Seattle, WA, 
      USA.
AD  - Department of Global Health, University of Washington, Seattle, WA, USA.
FAU - Makunike, Batsi
AU  - Makunike B
AD  - International Training and Education Center for Health (I-TECH), Harare, 
      Zimbabwe.
FAU - Holec, Marrianne
AU  - Holec M
AD  - International Training and Education Center for Health (I-TECH), Seattle, WA, 
      USA.
FAU - Murenje, Vernon
AU  - Murenje V
AD  - International Training and Education Center for Health (I-TECH), Harare, 
      Zimbabwe.
FAU - Stepaniak, Abby
AU  - Stepaniak A
AD  - International Training and Education Center for Health (I-TECH), Seattle, WA, 
      USA.
FAU - Xaba, Sinokuthemba
AU  - Xaba S
AD  - Ministry of Health and Child Care, Harare, Zimbabwe.
FAU - Balachandra, Shirish
AU  - Balachandra S
AD  - U.S. Centers for Disease Control and Prevention, Harare, Zimbabwe.
FAU - Tshimanga, Mufuta
AU  - Tshimanga M
AD  - Zimbabwe Community Health Intervention Project (ZiCHIRe), Harare, Zimbabwe.
FAU - Chitimbire, Vts
AU  - Chitimbire V
AD  - Zimbabwe Association of Church-related Hospitals (ZACH), Harare, Zimbabwe.
FAU - Barnhart, Scott
AU  - Barnhart S
AD  - International Training and Education Center for Health (I-TECH), Seattle, WA, 
      USA.
AD  - Department of Global Health, University of Washington, Seattle, WA, USA.
AD  - Department of Medicine, University of Washington, Seattle, WA, USA.
LA  - eng
GR  - #5U2GGH000972/US President;s Emergency Plan for AIDS Relief 
      (PEPFAR)/International
PT  - Journal Article
PL  - Switzerland
TA  - J Int AIDS Soc
JT  - Journal of the International AIDS Society
JID - 101478566
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Circumcision, Male/*adverse effects/methods
MH  - HIV Infections/etiology
MH  - Humans
MH  - Male
MH  - Program Evaluation
MH  - Young Adult
MH  - Zimbabwe
PMC - PMC5467584
OTO - NOTNLM
OT  - HIV prevention
OT  - Male circumcision
OT  - PrePex
OT  - Zimbabwe
OT  - adverse events
COIS- The findings and conclusions in this article are those of the author(s) and do 
      not necessarily represent the official position of the U.S. Centers for Disease 
      Control and Prevention (CDC). The authors declare that they have no competing 
      interests.
EDAT- 2017/04/01 06:00
MHDA- 2017/08/31 06:00
PMCR- 2017/02/21
CRDT- 2017/04/01 06:00
PHST- 2017/04/01 06:00 [entrez]
PHST- 2017/04/01 06:00 [pubmed]
PHST- 2017/08/31 06:00 [medline]
PHST- 2017/02/21 00:00 [pmc-release]
AID - 1289712 [pii]
AID - 10.7448/IAS.20.1.21394 [doi]
PST - ppublish
SO  - J Int AIDS Soc. 2017 Feb 21;19(1):21394. doi: 10.7448/IAS.20.1.21394.