(PlusNews) – Medical male circumcision has been a World Health Organization (WHO)-endorsed HIV prevention method for more than four years, with most countries still using relatively expensive surgical procedures that require anaesthetic, at least a couple of health workers and a six-week healing period. However, several new devices could revolutionize the amount of time, labour and money involved, enabling countries to rapidly scale up their programmes.
WHO has approved three devices – the Gomco Clamp, the Mogen Clamp and the Plastibell – for infant male circumcision, but none for adult male circumcision. In February 2011, the organization developed a framework for the clinical evaluation of devices for adult male circumcision.
Some of the devices under investigation include:
The Shang Ring – Developed in China, the Shang Ring comprises an inner and outer ring; the foreskin is placed between them and cut off, leaving the glans exposed during the seven-day healing period, after which the device is removed.
Clinical trials in China have found the device to be safe, and a pilot study in western Kenya’s Homa Bay found six mild adverse events – including skin injury, oedema and mild infection – when the device was tested on 40 HIV-negative men.
Several more studies on the Shang Ring are ongoing, including in Kenya and Uganda, on acceptability, safety and randomized controlled trials in Kenya and Zambia comparing it to surgical procedures.
The PrePex Device – Developed in Israel, the PrePex uses two rings and an applicator to restrict blood supply to the foreskin, which is removed, together with the device, after seven days. This method requires no anaesthesia.
A study of 40 men in Rwanda found one adverse event at removal of the device and a healing time of 17 days. More studies are ongoing and planned in Rwanda and Zimbabwe. The Rwandan government plans to scale up male circumcision using the PrePex device.
The Tara KLamp – Developed by Gurcharan Singh in Malaysia, the Tara KLamp has been widely used there for the circumcision of boys, including in public sector hospitals and circumcision campaigns. The device clamps on the foreskin so that the blood supply is cut off, and after seven to 10 days the foreskin is supposed to fall off with the clamp, but sometimes the clamp has to be surgically removed.
It has also been controversially promoted in Lesotho and South Africa. In 2009, a randomized controlled trial in Orange Farm, South Africa, found adverse events of 37 percent in the 35 men in the Tara KLamp study, against 3.4 percent in the 34 men in the surgical arm. Men circumcised using the KLamp also reported worse pain. The trial was stopped early due to the unacceptably high rate of adverse events, with the researchers noting that, “given the high rates of adverse events in this study and the low number of available studies, we strongly caution against the use of the TK for young adults, and we recommend careful evaluation of the procedure when performed on children”.
Nevertheless, Zulu king Goodwill Zwelithini in 2009 endorsed the KLamp for use in the traditional circumcision of boys in KwaZulu-Natal. It was used in about a quarter of the 35,000 circumcisions conducted; little data has emerged on complications. South African activist group, the Treatment Action Campaign declined to endorse the KLamp, stating that it was “simply too risky for use on male adults and should not be used in the public health system”.
In June 2011, the South African government announced that it would not be using the Tara KLamp as part of its official male circumcision scale-up. According to WHO, no further clinical studies of the Tara KLamp are planne