Accepted abstracts presented at IAS 2012; Washington DC, USA
- One Arm, Open Label, Prospective, Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Scale Up of Non-Surgical Circumcision when Performed by Nurses in Resource Limited Settings for HIV Prevention (Rwanda). The study was conducted in Rwanda Military Hospital, Kigali Rwanda, between July 2011 to September 2011. 10 nurses with no previous knowledge on PrePex device were trained for 3 days on PrePex™ circumcision method. 590 healthy adult male volunteers were enrolled in the study and distributed between 5 teams of 2 nurses each. AE data, severity and relation to device was gathered throughout weekly visit for 8 weeks follow up, post Removal. All 590 male subjects achieved the endpoint of complete circumcision with glans fully exposed. There were 2 device related moderate AE (rate of 0.34%) including 1 case of bleeding 6 hours post removal that required 1 suture and 1 case of erroneous placement that partially disturbed urination flow, and required replacement. There were 2 non-device related AE (rate of 0.34%), both moderate, including 1 subject self removal and 1 subject partial removal of the device, contrary to specific instructions. All AEs were easily resolved with simple intervention. The study statistically demonstrated that circumcision performed by nurses when using PrePex device is safe and effective. The procedure was bloodless and required no injected anesthesia, no sutures and no sterile settings (only standard consultation room).
- A Prospective, Randomized, Open-Label Trial Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale-Up of Male Circumcision in Resource-Limited Settings (Rwanda). A prospective, randomized controlled trial was conducted in Rwanda in which two MC methods were compared: the PrePex™ device for non-surgical MC with no anesthesia and the dorsal-slit method for surgical MC under local anesthesia (ratio 2:1). Mean procedure time of PrePex MC, combining placement and removal (3.1 minutes skin to skin), was significantly shorter compared to mean surgical procedure time (15.4 minutes skin to skin) (p<.0001). There were seven mild adverse events (AEs) related to surgical MC and zero related to PrePex. There were no device-related incidents. PrePex MC was found to be superior to surgical MC as measured by procedure time. PrePex demonstrated a better safety profile than surgical MC with a lower AE rate. Rwanda officially approved the device for use in the country, and changed its national plan to incorporate PrePex for scale up.