title: Safety and Efficacy of the PrePex Male Circumcision Device: Results From Pilot Implementation Studies in Mozambique, South Africa, and Zambia.
abstract: Fourteen countries in East and Southern Africa have engaged in national programs to accelerate the provision of voluntary medical male circumcision (VMMC) since 2007. Devices have the potential to accelerate VMMC programs by making the procedure easier, quicker, more efficient, and widely accessible.
  
  
  
  Pilot Implementation studies were conducted in Mozambique, South Africa, and Zambia. The primary objective of the studies was to assess the safety of PrePex device procedures when conducted by nurses and clinical officers in adults and adolescent males (13-17 years, South Africa only) with the following end points: number and grade of adverse events (AEs); pain-related AEs measured using visual analog score; device displacements/self-removals; time to complete wound healing; and procedure times for device placement and removal.
  
  
  
  A total of 1401 participants (1318 adult and 83 adolescent males) were circumcised using the PrePex device across the 3 studies. Rates of moderate/severe AEs were low (1.0%; 2.0%; and 2.8%) in the studies in Mozambique, Zambia, and South Africa, respectively. Eight early self-removals of 1401 (0.6%) were observed, all required corrective surgery. High rates of moderate/severe pain-related AEs were recorded especially at device removal in South Africa (34.9%) and Mozambique (59.5%). Ninety percent of participants were healed at day 56 postplacement.
  
  
  
  The study results from the 3 countries suggest that the implementation of the PrePex device using nonphysician health care workers is both safe and feasible, but better pain control at device removal needs to be put in place to increase the comfort of VMMC clients using the PrePex device.
authors.affiliation: *Global Health Department, FHI 360, Durham, NC; †Peri-natal HIV Research Unit, Faculty of Health Sciences, University of Witswatersrand, Johannesburg, South Africa; §University Teaching Hospital, Lusaka, Zambia; ‖Population Services International, Washington, DC; ¶Jhpiego, Maputo Moçambique; #Society for Family Health, Lusaka, Zambia; **Population Services International Lusaka, Zambia; ‡‡Society for Family Health, Johannesburg, South Africa; §§Jhpiego, Baltimore, MD; ‖‖Population Services International, Maputo, Mozambique; ¶¶FHI 360, Nairobi, Kenya; and ##Population Services International, Harare, Zimbabwe.
authors.forename: Paul
authors.initials: P
authors.lastname: Feldblum
authors.forename: Neil
authors.initials: N
authors.lastname: Martinson
authors.forename: Bruce
authors.initials: B
authors.lastname: Bvulani
authors.forename: Noah
authors.initials: N
authors.lastname: Taruberekera
authors.forename: Mehebub
authors.initials: M
authors.lastname: Mahomed
authors.forename: Namwinga
authors.initials: N
authors.lastname: Chintu
authors.forename: Minja
authors.initials: M
authors.lastname: Milovanovic
authors.forename: Catherine
authors.initials: C
authors.lastname: Hart
authors.forename: Scott
authors.initials: S
authors.lastname: Billy
authors.forename: Edgar
authors.initials: E
authors.lastname: Necochea
authors.forename: Alick
authors.initials: A
authors.lastname: Samona
authors.forename: Miriam
authors.initials: M
authors.lastname: Mhazo
authors.forename: Debora
authors.initials: D
authors.lastname: Bossemeyer
authors.forename: Jaim Jou
authors.initials: JJ
authors.lastname: Lai
authors.forename: Limakatso
authors.initials: L
authors.lastname: Lebinai
authors.forename: Tigistu A
authors.initials: TA
authors.lastname: Ashengo
authors.forename: Lucinda
authors.initials: L
authors.lastname: Macaringue
authors.forename: Valentine
authors.initials: V
authors.lastname: Veena
authors.forename: Karin
authors.initials: K
authors.lastname: Hatzold
mesh_terms: D000293:Adolescent; D000328:Adult; D002944:Circumcision, Male / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009073:Mozambique; D010147:Pain Measurement; D011446:Prospective Studies; D013019:South Africa; D014945:Wound Healing; D055815:Young Adult; D015024:Zambia