title: Adverse event profile of a mature voluntary medical male circumcision programme performing PrePex and surgical procedures in Zimbabwe.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: International Training and Education Center for Health (I-TECH), Seattle, WA, USA.|Department of Epidemiology, University of Washington, Seattle, WA, USA.
authors.forename: Aaron F
authors.initials: AF
authors.lastname: Bochner
authors.affiliation: International Training and Education Center for Health (I-TECH), Seattle, WA, USA.|Department of Global Health, University of Washington, Seattle, WA, USA.
authors.forename: Caryl
authors.initials: C
authors.lastname: Feldacker
authors.affiliation: International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.
authors.forename: Batsi
authors.initials: B
authors.lastname: Makunike
authors.affiliation: International Training and Education Center for Health (I-TECH), Seattle, WA, USA.
authors.forename: Marrianne
authors.initials: M
authors.lastname: Holec
authors.affiliation: International Training and Education Center for Health (I-TECH), Harare, Zimbabwe.
authors.forename: Vernon
authors.initials: V
authors.lastname: Murenje
authors.affiliation: International Training and Education Center for Health (I-TECH), Seattle, WA, USA.
authors.forename: Abby
authors.initials: A
authors.lastname: Stepaniak
authors.affiliation: Ministry of Health and Child Care, Harare, Zimbabwe.
authors.forename: Sinokuthemba
authors.initials: S
authors.lastname: Xaba
authors.affiliation: U.S. Centers for Disease Control and Prevention, Harare, Zimbabwe.
authors.forename: Shirish
authors.initials: S
authors.lastname: Balachandra
authors.affiliation: Zimbabwe Community Health Intervention Project (ZiCHIRe), Harare, Zimbabwe.
authors.forename: Mufuta
authors.initials: M
authors.lastname: Tshimanga
authors.affiliation: Zimbabwe Association of Church-related Hospitals (ZACH), Harare, Zimbabwe.
authors.forename: Vts
authors.initials: V
authors.lastname: Chitimbire
authors.affiliation: International Training and Education Center for Health (I-TECH), Seattle, WA, USA.|Department of Global Health, University of Washington, Seattle, WA, USA.|Department of Medicine, University of Washington, Seattle, WA, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Barnhart
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002944:Circumcision, Male / Q000009:adverse effects* / Q000379:methods; D015658:HIV Infections / Q000209:etiology; D006801:Humans; D008297:Male; D015397:Program Evaluation; D055815:Young Adult; D015030:Zimbabwe
keywords: HIV prevention; Male circumcision; PrePex; Zimbabwe; adverse events