/ 27 July 2012

Circumcision: New devices can boost ‘snip’ rates

The PrePex allows non-surgical circumcision procedures that can be performed by nurses.
The PrePex allows non-surgical circumcision procedures that can be performed by nurses.

Delegates at the 19th International Aids conference in Washington, DC, in the United States this week were convinced the world was on the cusp of a major advance against HIV and that a medical device, known as the PrePex, could help 14 African countries, including South Africa, to speed up male circumcision to achieve a goal of circumcising 80% of men between the ages of 15 and 49 by 2015.

Earlier this year, the WHO also approved an application by a Chinese company, Wu Hu SNNDA Medical Treatment Applica Technology, for another device, the Shang ring, to undergo the prequalification process, which involves a long, complex scientific assessment that requires a manufacturer to support three different kinds of trials, conducted by the WHO, in at least two countries.

Large donors, such as the US government's President's Emergency Fund for Aids Relief and the Bill and Melinda Gates Foundation, will only support medical circumcision devices after they have been "prequalified" by the WHO.

Research has shown that medical circumcision, involving the removal of the entire foreskin, can reduce men's risk of acquiring HIV from women by up to 60%. Longer-term follow-up studies have shown that this preventive benefit increases with time – a South African study in Orange Farm near Johannesburg found that circumcision reduced the rate of new HIV infections among circumcised men by 76% over a three-year period.

According to mathematical modelling studies, up to 20% of new HIV infections could be averted by 2025, saving $16.6-billion in future medical costs, if 14 Southern and East African countries achieved the 80% goal to which they committed themselves at the Conference on Aids in Africa in Ethiopia last year.  

But according to US government figures, most countries are lagging far behind that – they have reached only 8% of the target. A male circumcision report released by US and African Aids advocates last week warned that, "given the slow progress to date, meeting this by 2015 may not be possible, representing a major missed opportunity".

The report, "A Call to Action on Voluntary Medical Male Circumcision: Implementing a Key Component of Combination HIV Prevention", urged African governments to "move with speed" to alter the epidemic's trajectory.

HIV experts in Washington were optimistic that medical circumcision devices such as the PrePex and the Shang ring could be "part of the answer" to Africa's backlog. Clinical trials have shown that the PrePex, which is furthest in the prequalification process, will be much quicker and simpler than the three surgical circumcision methods the WHO currently recommends.  

The PrePex device, manufactured by the Israeli company Circ MedTech, works by using an elastic band that compresses the foreskin against a rigid plastic ring that is placed on the inside of the penis's foreskin. The elastic band cuts off the blood supply to the foreskin, which becomes harder, loses sensation and dries out. According to a technical expert from the US government's Office of the Global Aids Co-ordinator (the president's fund headquarters), Dr Jason Reed, the process is similar to that of an umbilical cord clamp.

"Once the foreskin has 'died', a ­client returns a week later to have the device removed and the hardened skin is then easily cut away," he said.  

Although a local analgesic ointment is applied when the inner ring is inserted beneath the foreskin, no local anaesthesia – and thus no needles – are required, as with surgical circumcisions. And because live tissue is not cut, a sterile environment and stitches are not needed. There is usually no bleeding and research studies have shown that pain levels are comparable with, or in some cases lower than, those involving surgical circumcisions.   

A study conducted in Rwanda last
year found that the PrePex procedure could be performed in one-fifth of the time (three minutes) of an average surgical procedure (15 to 30 minutes). The study also found that most participants using the PrePex device were able to return to work within three hours after the device had been put on, whereas those undergoing surgical circumcisions often needed a few days to recover. Another Rwandan study has shown that the PrePex procedure can be carried out by "low-cadre nurses", unlike surgical circumcisions, which require skilled surgeons or surgical nurses.

Reed said: "Most African countries have a shortage of healthcare providers with surgical skills, particularly doctors, which makes it challenging to perform high volumes of surgical circumcisions. A medical device that would eliminate the need for such constrained resources could help to speed up the process greatly."

The PrePex device will soon be tested with community health workers administering it. A second round of trials, required by the prequalification process, is now being conducted in Zimbabwe.

The Shang ring, which works in a similar way, is being tested in Kenya and Zambia.  

Reed said: "Eighty percent of men circumcised by 2015 translates to 20-million circumcisions. That figure sounds like wishful thinking within health settings where resources are scarce.

"We're hoping that governments' sense of the feasibility of so many male circumcisions in such a short time will undergo a manifold change and that policymakers and leaders will put 100% of their weight behind it if they have access to circumcision devices that can complement that surgical process."

Reed said more men might be willing to be circumcised if they had more options. "Devices won't solve every problem, but we're hopeful that they will provide more flexible circumcision options."

TaraKlamp not certified
The TaraKlamp, a circumcision device used by the provincial  government in KwaZulu-Natal, has not been approved by the World Health Organisation (WHO) and its Malaysian

manufacturer, Taramedic Corp­oration, has not applied to have it verified.

The clamp is meant to cut off the blood supply to the foreskin, causing it to dry out and fall from the device after seven to 10 days. But according to South African HIV lobby group the Treatment Action Campaign (TAC), this often does not happen, resulting in the clamp having to be removed surgically.

Only one study on the TaraKlamp's safety and efficacy when used on adults has been published in a peer-reviewed journal and the South African Medical Journal study strongly cautioned against its use. The trial had to be stopped twice after a number of participants experienced bleeding, infection and problems with urinating.

A March 2009 WHO report said "the low acceptability and high complication rates [of the TaraKlamp] illustrate the difficulties of introducing a device in a new population and the need for careful evaluation by clinicians independent of the device manufacturers".

The TAC has described the TaraKlamp as an "unethical medical intervention" and accused the provincial government of "using an unsafe circumcision device that will injure thousands of men".

Mia Malan works for the ­Discovery Health Journalism Centre at ­Rhodes University