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
Published manuscript at the Journal of Acquired Immune Deficiency Syndromes (JAIDS): 1 July 2013 – Volume 63 – Issue 3 – p 315–322. Click here for the full version
This study represents the third and final clinical evaluation of PrePex, performed in mid-2011 in Rwanda, based on World Health Organization suggested framework for evaluating Male circumcision devices, following the validation of safety, efficacy and supremacy over surgical circumcision performed by surgeons. The national goal in Rwanda is to offer voluntary medical male circumcision (VMMC) to 2 million men within 2 years to decrease HIV incidence, and this can only be achieved if nurses can safely conduct the procedure. The Rwandan National Ethics Committee approved the study. The study was conducted in the Rwanda Military Hospital, Kigali Rwanda, between July 2011 and September 2011. 10 nurses with no previous experience with PrePex underwent the PrePex three day training program. 590 healthy adult male volunteers were enrolled in the study and distributed between 5 teams of 2 nurses each. Adverse Event data, severity and relation to device was gathered at 8 weekly visits and follow up, post removal. The study statistically demonstrated that circumcision performed by nurses when using PrePe is safe and effective. The procedure was bloodless and required no injected anesthesia, no sutures and no sterile settings (only standard consultation room). The device was officially approved for use in Rwanda. PrePex has the potential to facilitate rapid, safe, MC scale-up programs for HIV prevention by nurses, an imminent need in Sub Saharan Africa where physicians are a limited resource.
A cohort field study was conducted in Rwanda during 2012 on 590 men, assessing the safety and efficacy of task shifting from physicians to nurses. The study statistically demonstrated that circumcision performed by nurses when using the PrePex device is safe and effective.