According to Dr. Jason Reed, an epidemiologist in the global AIDS division of the Centers for Disease Control and Prevention, 2 of 590, or 0.34 percent, is a tenth the typical complication rate of surgical circumcision.
None of the men became infected.
On the 10-point pain scale, they reported on average only about 1 when the ring was placed and only 3 when it was removed (about the same level of pain caused by erections during the week they wore it).
By the end of the study, the two-nurse teams could do a procedure in three minutes.
By contrast, Dr. Reed said, the best surgical “assembly lines” - a practice being pioneered in Africa with American taxpayer support - can get down to seven minutes per patient, but only by getting six nurses and a surgeon into a tight harmony.
In theory, he said, breaking that into three two-nurse PrePex teams could mean circumcising around 400 men a day, rather than the 60 to 80 a busy team now does. And the surgeon could go do something more important.
Safety and Efficacy of the PrePex Device for Rapid Scale-Up of Male Circumcision for HIV Prevention in Resource-Limited Settings
Randomized controlled trials have shown that male circumcision reduces the lifetime risk of HIV infection by 53%–60%. Recent meta-analyses confirm that male circumcision can curtail the heterosexual spread of HIV. The World Health Organization and the Joint United Nations Program on HIV/AIDS recommend consideration of male circumcision along with other preventive measures in countries with predominantly heterosexual epidemics. More than 38 million adolescent and adult males in Africa could benefit from circumcision for HIV prevention.
In the Republic of Rwanda, only 15% of men are circumcised. The government of Rwanda is implementing a nationwide program to circumcise 2 million men by the end of 2012. Given limited resources, such a goal is achievable only with a nonsurgical method that can be performed by nonphysician staff in a nonsterile setting. This report describes a government-sponsored study to test the PrePex device for adult male circumcision.
Bitega, Jean Paul MD, MMed (Surgery); Ngeruka, Muyenzi Leon MD; Hategekimana, Theobald MD; Asiimwe, Anita MD, MPH; Binagwaho, Agnes MD, PhD
In fact, Dr. Reed said, American AIDS dollars for circumcisions often go toward an operating room with lights and an instrument sterilizer. Instead of circumcisions, hospitals are more likely to use it for procedures like saving women in obstructed labor.
“Which is understandable - of course that takes precedence,” he said. “But then the circumcisions don’t get done.”
Robert C. Bailey, an epidemiologist at the University of Illinois at Chicago who helped design Kenya’s circumcision efforts, opposes timesaving devices because training nurses in minor surgery has other benefits, he said. A trained nurse could close a wound or take out an appendix, for example. And the time-consuming parts of the process are counseling and H.I.V. testing, Dr. Bailey said, so “doing it in five minutes instead of 20 is trivial.”
But he conceded, “If PrePex really doesn’t require anesthesia, that’s truly an advance.”
Rwanda is training 150 two-nurse teams; it is a small country, but it serves as a bellwether for Africa because its health care system is well organized, government corruption scandals are rare, and it is heavily supported by donor funds.
Other, rival devices are not far along in safety testing or are failing it.