title: One-arm, open-label, prospective, cohort field study to assess the safety and efficacy of the PrePex device for scale-up of nonsurgical circumcision when performed by nurses in resource-limited settings for HIV prevention.
abstract: OBJECTIVE
  To assess the safety and efficacy of the PrePex device when circumcision is performed by lower cadre nurses, among healthy adult men scheduled for voluntary circumcision, in preparation for scale-up.
  
  
  METHODS
  Single-center 3-month nonrandomized field study was conducted in Rwanda. Ten nurses were trained for 3 days on the PrePex circumcision method. Healthy noncircumcised adult male volunteers (n = 590) were enrolled, distributed between 5 teams of 2 nurses each, and underwent circumcision using the PrePex device, which employs radial elastic pressure to the foreskin, leading to distal necrosis. Adverse event (AE) data were gathered for 6 weeks postremoval.
  
  
  RESULTS
  All 518 subjects from the pilot and pivotal phases achieved complete circumcision. There were 5 AEs on 4 subjects (rate of 0.96%, 95% confidence interval: 0.31 to 2.24). There were 4 device-related AEs, including 1 case of bleeding postremoval, 1 case of high pain the night before the removal (which resulted in subject self-removal of the device and caused mild bleeding), 1 erroneous placement, and 1 subject partial removal of the device. There was 1 non-device-related AE. AEs were moderate and were resolved with simple intervention.
  
  
  CONCLUSIONS
  The study demonstrated that circumcision performed by nurses using the PrePex device is safe, effective, and easy to train. The procedure was minimally invasive and did not require injected anesthesia, sutures, or sterile settings. PrePex has the potential to help facilitate rapid, safe, nonphysician male circumcision scale-up programs for HIV prevention, an imminent need in sub Saharan Africa where physicians are limited.
authors: Ministry of Health, Republic of Rwanda, Kigali, Rwanda. mutabazivincent@yahoo.com
authors: Vincent
authors: V
authors: Mutabazi
authors: Steven A
authors: SA
authors: Kaplan
authors: Emile
authors: E
authors: Rwamasirabo
authors: Jean P
authors: JP
authors: Bitega
authors: Muyenzi L
authors: ML
authors: Ngeruka
authors: Dominique
authors: D
authors: Savio
authors: Corine
authors: C
authors: Karema
authors: Agnes
authors: A
authors: Binagwaho
mesh_terms: D000328:Adult; D002944:Circumcision, Male / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D015331:Cohort Studies; D015658:HIV Infections / Q000517:prevention & control* / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D009726:Nurses; D009732:Nursing Care; D010147:Pain Measurement; D012432:Rwanda; D013525:Surgical Instruments / Q000009:adverse effects; D055815:Young Adult