Nonsurgical Adult Male Circumcision Safe, Effective

Troy Brown

December 16, 2011

December 16, 2011 — Rwanda might be closer to meeting its goal of offering voluntary male circumcision to 2 million adult men in 2 years as part of a comprehensive HIV prevention initiative, according to a study presented here at the 16th International Conference on AIDS and Sexually Transmitted Infections in Africa.

Lead investigator Vincent Mutabazi, MD, and colleagues from the Ministry of Health in Rwanda conducted a single-group, open-label, prospective cohort field study to assess the safety of nurses using a nonsurgical circumcision device (PrePex, Circ MedTech).

The World Health Organization (WHO) and UNAIDS "recommend that male circumcision be promoted as part of a comprehensive HIV prevention package, in light of strong clinical evidence showing that circumcised men reduce their risk of HIV infection by 60% in sub-Saharan Africa," Dr. Mutabazi in an email interview with Medscape Medical News.

"Countries with low male circumcision rates, high HIV prevalence, and predominantly heterosexual epidemics were encouraged to scale-up male circumcision programs as part of their national HIV prevention strategies," he explained. "Accordingly, the government of Rwanda plans to implement a nationwide voluntary medical male circumcision program, with the objective of reaching 2 million adult men by the end of 2012, to achieve the national goal of decreasing the HIV incidence rate by 50%."

Dr. Mutabazi pointed out that such a goal would take far too long to meet with WHO-approved surgical methods. "Hence, the government was interested in exploring innovations in male circumcision that would be more suitable for nonphysicians in nonsterile rural settings, which would minimize the burden on the existing healthcare system, which is already strained handling life-saving procedures," he added.

The study was conducted at Kanombe Hospital in Kigali, Rwanda, from July to September. Ten nurses unfamiliar with the device were trained for 3 days on the procedure, and 575 healthy adult men were assigned to 1 of 5 two-nurse teams.

After 7 days, patients returned to have the device and dead tissue removed. The device stops blood flow to the distal foreskin, causing tissue necrosis. Patients were seen weekly for 6 weeks after removal to assess for the presence of adverse events, severity, and relation to the device.

The procedure was well tolerated and patients required no anesthesia. There was no bleeding during placement or removal of the device, and a sterile setting wasn't needed.

All 575 participants met the end point of complete circumcision, with full exposure of the glans. There were only 2 device-related moderate adverse events (rate of 0.35%). One subject experienced bleeding 6 hours after the procedure that required 1 suture, and 1 device was improperly placed, partially obstructing urine flow and requiring replacement.

Two nondevice-related adverse events (rate of 0.35%) occurred. One moderate adverse event occurred when a patient removed the device himself; another occurred after a patient partially removed the device against instruction. All adverse events were managed with simple intervention.

"If the male circumcision procedure can be performed safely with a device by nonphysicians (who are relatively more numerous that physicians), the number of men who can have the procedure will increase significantly," Rebeca M. Plank, MD, from the division of infectious diseases at Brigham and Women's Hospital, Boston, Massachusetts, said in an email to Medscape Medical News. She was not involved in the study.

"Nurses from less centralized health posts can be trained in a central location, then return to their posts where the procedure can be done locally, eliminating the need for the men undergoing the procedure to take time off from work and incur the costs of travel to have the procedure," she explained.

In addition, this procedure can be done in a standard consultation room without the need for a sterile operating room or sterile instruments. If the low rate of adverse events seen holds true in practice, there will be few costs related to managing those, said Dr. Plank.

The biggest unanswered question for the Rwanda Ministry of Health will be how the procedure fares when implemented in massive volume, said Dr. Mutabazi. "We are waiting for a recommendation from the World Health Organization to allow the ministry to use [this device] for the national scale-up for male circumcision, using public donor funds," he said.

"For adults above the age of 21, the Rwanda Ministry of Health has completed all formal clinical evaluation for the circumcision device, and we are moving toward scale-up for male circumcision while closely monitoring the safety of [this device] in larger numbers of adults, once WHO approves the device," Dr. Mutabazi said.

"In the near future, we are planning to conduct a study on the use of this device in the 15- to 20-year age bracket so that we have full coverage as it relates to our national plan, which calls for [age] 15 to 49 scale-up," Dr. Mutabazi added.

The studies were funded by the Rwanda Ministry of Health. The PrePex devices and removal accessories were donated by Circ MedTech. Dr. Mutabazi and Dr. Plank have disclosed no relevant financial relationships.

16th International Conference on AIDS and Sexually transmitted Infections in Africa (ICASA). Presented December 8, 2011.

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