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.

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.

HIV prevention: male circumcision comparison between a nonsurgical device to a surgical technique in resource-limited settings: a prospective, randomized, nonmasked trial.

BACKGROUND: Randomized controlled trial studies have shown that male circumcision (MC) can reduce the risk of HIV infection by 53%-60%. The Joint United Nations Program on HIV and AIDS announced a 5-year plan to voluntarily circumcise 20 million men by 2015. There are more than 38 million males in sub-Saharan Africa that could benefit from MC for HIV prevention by 2015. Surgical MC is impractical for nation-wide coverage in resource-limited settings. Rwanda intends to launch a voluntary MC program to reach 2 million adult men in 2 years, an unattainable goal with surgical MC. This study was designed to compare a new nonsurgical device with surgical MC to assess nonsurgical MC suitability for scale-up. METHODS: Prospective, randomized controlled trial in Rwanda in which the PrePex device was used for nonsurgical MC and the dorsal-slit method for surgical MC (ratio: 2:1). Subjects were healthy adult male volunteers aged 21-54 years. The primary endpoint, set by World Health Organization, was total MC procedure time. FINDINGS: Of 217 eligible subjects, 144 were randomized to the PrePex/nonsurgical arm and 73 to the surgical arm. All subjects were circumcised in 10 working days. Nonsurgical MC was bloodless, without anesthesia, sutures, or sterile setting and with mean procedure time of 3.1 minutes (skin to skin), was significantly shorter than mean surgical procedure time (15.4 minutes skin to skin) (P < 0.0001). There were no device-related adverse events. Healing time of the PrePex arm was longer than the surgical arm. CONCLUSION: PrePex, the nonsurgical MC, takes significantly less time than surgical, is as safe, does not require injections or sterile settings, is bloodless and seems to be suitable for nurses.