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.