Innovative male circumcision device for HIV prevention receives WHO prequalification
The ShangRing, a novel medical device for voluntary medical male circumcision, has received prequalification from the World Health Organization (WHO) for use. The prequalification indicates that the ShangRing meets international standards of safety and has the potential to rapidly increase access to the device in sub-Saharan Africa and other regions where the burden of HIV is highest. Conclusive clinical research demonstrates that circumcision can reduce male acquisition of HIV through vaginal intercourse by up to 60 percent.
"This is a major milestone toward improving access to voluntary medical male circumcision, which will help to prevent HIV acquisition in low-resource settings and contribute to the international efforts to achieve an AIDS-free generation," said Mr. Shang Jianzhong, inventor and board chairman of Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd.
In 2007, WHO and the Joint United Nations Programme on HIV/AIDS (UNAIDS) recommended that voluntary medical male circumcision be included in HIV prevention programs in southern and eastern Africa, countries with high rates of heterosexually transmitted HIV and low rates of male circumcision. While WHO prequalification does not replace national regulatory approvals, it acts as a guide for many national health agencies and enables procurement of the device by programs such as the United States President's Emergency Plan for AIDS Relief (PEPFAR).
The ShangRing is produced by Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd of China. It consists of two concentric plastic rings that lock together over the foreskin. Unlike the conventional surgery, male circumcision with the ShangRing requires no sutures, involves minimal bleeding and is disposable. It is the first device prequalified by WHO for circumcision of both adults and adolescent boys ages 13 to 17 years.
"The ShangRing is very simple to use and reduces the time needed to perform male circumcision by about half, compared to conventional procedures," says Jairus Oketch, Kenya Registered Community Health Nurse, Homa Bay District Hospital. "Expanded use of the device will enable countries to deliver safe, efficient, high-quality male circumcision to more people and thus reduce the spread of HIV."
The ShangRing was assessed among more than 1,900 healthy adult men ages 18 years and older in five studies conducted in Kenya, Uganda and Zambia and among more than 350 adolescent males ages 13 to 17 years in Kenya and Uganda. The research in Kenya and Zambia was supported by a grant from the Bill & Melinda Gates Foundation to FHI 360 and conducted in collaboration with EngenderHealth, FHI 360 and Weill Cornell Medical College. The partners were instrumental in clinical research, provider training, inspection of the manufacturing facility and coordination with WHO.