The Rwandan Government has completed its third trial of PrePex with nearly 600 volunteers and has concluded the device is a safe and efficient way of performing circumcisions. It now aims to reduce new HIV infections by fifty percent, in part through a campaign to circumcise two million adult men over the next two years.
The results were presented at the 16th International Conference on AIDS and Sexually Transmitted Infections (STIs) in Africa (ICASA).
Michel Sidibé, Executive Director of UNAIDS said :
"Innovation is key to achieving our target of 20 million voluntary adult male circumcisions by 2015 and saving millions of lives. Devices such as PrePex have the potential to facilitate safe and rapid scale up of male circumcision for HIV prevention, an urgent need in Sub Saharan Africa ...
We commend the government of Rwanda for progressing the science of HIV prevention for the benefit of the region."
An evaluation from the World Health Organization said the study of the PrePex device provides further clinical evidence that circumcision performed by nurses when using the PrePex device is fast, safe and effective, enabling a bloodless procedure that requires no injected anesthesia, no sutures and no sterile settings.
Agnes Binagwaho, MD, M(Ped) PhD hc, The Minister of Health of Rwanda said :
"We are unwilling to allow our health system resource challenges to dissuade us from our mission: to create a healthier, HIV-free Rwanda. We are committed to finding innovative, safe and effective solutions to make this happen ...
This study shows that with the non-surgical PrePex device we can safely task-shift circumcision from surgeons and family physicians to nurses, which if nationally scaled up, would make a significant contribution to our public health system."
Controversy regarding circumcision and HIV riskThere has been some controversy regarding the effectiveness of circumcision to prevent the spead of the HIV virus. Circumcision rates are far higher in the United States than in Western Europe, yet HIV cases remain stubbornly higher in the US and W. Europe, contrary to what might be expected if circumcision is so effective.
While many doctors are in agreement as to its effectiveness in Africa, the topic has its detractors that range from those demanding more research and scientific proof, some who point to contradictory findings from several studies, to wild conspiracy theories.
How does the device work?The device basically works by stopping the flow of blood to the foreskin. It remains in situ for a week, after which time it is removed along with the foreskin that has died due to lack of circulation.
The average time for installation of the device is less than three minutes, with the advantage that it doesn't involve surgery or cause blood loss, and thus can be performed by nurses.
The device and procedure, which can be performed in a regular doctor's consulting room has an AE rate of 0.34% (2 out of 590), and the total study adverse event (AE) rate when performed by nurses was 0.83%. All resolved with minimal intervention, and the AE rate was lower than previously reported AE rates for surgical male circumcision when performed by surgeons (4.8%).
In Rwanda there are only 300 trained physicians for around 10 million people, and nearly 90 percent of the population live in rural areas that lack sterile facilities.
Analysis shows that scaling up circumcision via surgical procedures would drain resources from surgeons who work in vital life saving areas, not to mention the likely resistance from the local population.
The study was approved by the Rwanda National Ethics Committee and was conducted in Kanombe Hospital, Kigali Rwanda, between July 2011 and October 2011.
Written by Rupert Shepherd.