title: Safety and Acceptability of the PrePex Device When Used in Routine Male Circumcision Service Delivery During Active Surveillance in Zimbabwe.
abstract: Male circumcision devices have the potential to accelerate voluntary medical male circumcision roll-out, with PrePex being one promising device. Here, we present findings on safety and acceptability from active surveillance of the implementation of PrePex among 1000 males circumcised in Zimbabwe.
  
  
  
  The first 1000 men consecutively circumcised using PrePex during routine service delivery were actively followed up. Outcome measures included PrePex uptake, attendance for postcircumcision visits, and adverse events (AEs). A survey was conducted among 500 consecutive active surveillance clients to assess acceptability and satisfaction with PrePex.
  
  
  
  A total of 2156 men aged 18 years or older were circumcised across the 6 PrePex active surveillance sites. Of these, 1000 (46.4%) were circumcised using PrePex. Among them, 4 (0.4%) self-removals that required surgery (severe AEs) were observed. Six (0.6%) removals by providers (moderate AEs) did not require surgery. A further 280 (28%) AEs were mild or moderate pain during device removal. There were also 12 (1.2%) moderate AEs unrelated to pain. All AEs resolved without sequelae. There was high adherence to follow-up appointments, with 97.7% of clients attending the scheduled day 7 visit. Acceptability of PrePex was high among survey participants, 93% indicated willingness to recommend the device to peers. Of note, 95.8% of respondents reported experiencing pain when the device was being removed. Additionally, 85.2% reported experiencing odor while wearing the device or during removal.
  
  
  
  Active surveillance of the first 1000 men circumcised using PrePex suggests that the device is both safe and acceptable when used in routine service delivery.
authors.affiliation: *Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe; †Population Services International, Harare, Zimbabwe; ‡Ministry of Health and Child Care, Harare, Zimbabwe; §United States Agency for International Development, Harare, Zimbabwe; ‖University of Zimbabwe College of Health Sciences, Harare, Zimbabwe; ¶United States Agency for International Development, Washington, DC; and #University College London, London, United Kingdom.
authors.forename: Webster
authors.initials: W
authors.lastname: Mavhu
authors.forename: Karin
authors.initials: K
authors.lastname: Hatzold
authors.forename: Getrude
authors.initials: G
authors.lastname: Ncube
authors.forename: Sinokuthemba
authors.initials: S
authors.lastname: Xaba
authors.forename: Ngonidzashe
authors.initials: N
authors.lastname: Madidi
authors.forename: Jo
authors.initials: J
authors.lastname: Keatinge
authors.forename: Efison
authors.initials: E
authors.lastname: Dhodho
authors.forename: Christopher A
authors.initials: CA
authors.lastname: Samkange
authors.forename: Mufuta
authors.initials: M
authors.lastname: Tshimanga
authors.forename: Tonderayi
authors.initials: T
authors.lastname: Mangwiro
authors.forename: Owen
authors.initials: O
authors.lastname: Mugurungi
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Njeuhmeli
authors.forename: Frances M
authors.initials: FM
authors.lastname: Cowan
mesh_terms: D000293:Adolescent; D000328:Adult; D002944:Circumcision, Male / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009812:Odorants; D010146:Pain; D010342:Patient Acceptance of Health Care; D055815:Young Adult; D015030:Zimbabwe