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.
Trial registration: ClinicalTrials.gov NCT01284088.