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.

Safety and efficacy of the PrePex device for rapid scale-up of male circumcision for HIV prevention in resource-limited settings.

OBJECTIVE: To assess the safety and efficacy of the PrePex device for nonsurgical circumcision in adult males as part of a comprehensive HIV prevention program in Rwanda. METHODS: Single-center 6-week noncontrolled study in which healthy men underwent circumcision using the PrePex device, which employs fitted rings to clamp the foreskin, leading to distal necrosis. In the first phase of the study, the feasibility of the procedure was tested on 5 subjects in a sterile environment; in the main phase, an additional 50 subjects were circumcised in a nonsterile setting by physicians or a nurse. Outcome measures included the rate of successful circumcision, time to complete healing, pain, and adverse events. RESULTS: In the feasibility phase, all 5 subjects achieved complete circumcision without adverse events. In the main phase, all 50 subjects achieved circumcision with 1 case of diffuse edema after device removal, which resolved with minimal intervention. Pain was minimal except briefly during device removal (day 7 after placement in most cases). The entire procedure was bloodless, requiring no anesthesia, no suturing, and no sterile settings. Subjects had no sick/absent days associated with the procedure. Median time for complete healing was 21 days after device removal. There were no instances of erroneous placement and no mechanical problems with the device. CONCLUSION: The PrePex device was safe and effective for nonsurgical adult male circumcision without anesthesia or sterile settings and may be useful in mass circumcision programs to reduce the risk of HIV infection, particularly in resource-limited settings.