title: A Phase II Randomized Controlled Trial Comparing Safety, Procedure Time, and Cost of the PrePex™ Device to Forceps Guided Surgical Circumcision in Zimbabwe.
abstract: BACKGROUND
  The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS promote MC (male circumcision) as a key HIV prevention strategy where HIV prevalence and incidence are high and MC prevalence is low. In Zimbabwe, to achieve the 1.26 million circumcisions needed to be performed by 2015 to achieve optimal MC coverage, a new approach was needed. The primary objective of the current trial was to assess the performance (safety, procedure time, and cost) of the PrePex device compared to forceps-guided surgical circumcision.
  
  
  RESULTS
  This Phase II, randomized, open-label trial in Zimbabwe involved healthy, non-circumcised adult male volunteers who were randomly assigned to the PrePex device (n = 160) or surgical arm (n = 80). Three doctors and 4 nurses, all certified on both circumcision methods, performed the procedures. The PrePex device procedure involves a plastic ring with a rubber O-ring that necrotizes the foreskin to facilitate easy and minimally invasive removal. Total procedure time was the primary endpoint. Adverse event (AE) data were also gathered for 90 days post-procedure. All 80 participants in the surgical arm and 158 participants in the PrePex arm achieved complete circumcision. The total procedure time for the PrePex device was approximately one-third of the total surgical procedure (4.8 minutes, Standard Deviation [SD]: 1.2 versus 14.6 minutes; SD: 4.2; p<0.00001). There were 2 AEs for 2 participants (rate of 1.3%, 95% Confidence Interval: 0.0025-4.53%), which were resolved with simple intervention. The AEs were device related, including 1 case of pain leading to device removal and 1 case of removal of the device.
  
  
  CONCLUSIONS
  The trial supports previous studies' conclusions that the PrePex procedure is safe, quick, easy to apply, and effective in terms of procedure time as an alternative to traditional surgical circumcision. The PrePex device has great potential for use in overburdened health systems and in resource-limited settings and is recommended for use in rapid scale-up of adult MC in Zimbabwe.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01956370.
authors.affiliation: Department of Community Medicine, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
authors.forename: Mufuta
authors.initials: M
authors.lastname: Tshimanga
authors.affiliation: Department of Surgery, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
authors.forename: Tonderayi
authors.initials: T
authors.lastname: Mangwiro
authors.affiliation: Ministry of Health and Child Care, Harare, Zimbabwe.
authors.forename: Owen
authors.initials: O
authors.lastname: Mugurungi
authors.affiliation: Ministry of Health and Child Care, Harare, Zimbabwe.
authors.forename: Sinokuthemba
authors.initials: S
authors.lastname: Xaba
authors.affiliation: Zimbabwe National Family Planning Council, Harare, Zimbabwe.
authors.forename: Munyaradzi
authors.initials: M
authors.lastname: Murwira
authors.affiliation: Battelle Health and Analytics, Seattle, United States of America.
authors.forename: Danuta
authors.initials: D
authors.lastname: Kasprzyk
authors.affiliation: Battelle Health and Analytics, Seattle, United States of America.
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Montaño
authors.affiliation: United Nations Population Fund, Harare, Zimbabwe.
authors.forename: Daisy
authors.initials: D
authors.lastname: Nyamukapa
authors.affiliation: United Nations Population Fund, Harare, Zimbabwe.
authors.forename: Basile
authors.initials: B
authors.lastname: Tambashe
authors.affiliation: Department of Community Medicine, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
authors.forename: Pesanai
authors.initials: P
authors.lastname: Chatikobo
authors.affiliation: Department of Community Medicine, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
authors.forename: Patricia
authors.initials: P
authors.lastname: Gundidza
authors.affiliation: Ministry of Health and Child Care, Harare, Zimbabwe.
authors.forename: Gerald
authors.initials: G
authors.lastname: Gwinji
mesh_terms: D000293:Adolescent; D000328:Adult; D002944:Circumcision, Male / Q000191:economics* / Q000295:instrumentation*; D003362:Cost-Benefit Analysis; D015658:HIV Infections / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D012449:Safety; D013525:Surgical Instruments / Q000191:economics*; D013997:Time Factors; D055815:Young Adult; D015030:Zimbabwe