AIDS Prevention Inspires Ways to Make Circumcisions Easier
David Cohen, M.D.·Published 2 February 2012·8 min read
Key points
The day of the assembly-line circumcision is drawing closer.
Now that three studies have shown that circumcising adult heterosexual men is one of the most effective “vaccines” against AIDS - reducing the chances of infection by 60 percent or more - public health experts are struggling to find ways to make the process faster, cheaper and safer.
The goal is to circumcise 20 million African men by 2015, but only about 600,000 have had the operation thus far.
So donors are pinning their hopes on several devices now being tested to speed things up.
The day of the assembly-line circumcision is drawing closer.
Now that three studies have shown that circumcising adult heterosexual men is one of the most effective “vaccines” against AIDS - reducing the chances of infection by 60 percent or more - public health experts are struggling to find ways to make the process faster, cheaper and safer.
The goal is to circumcise 20 million African men by 2015, but only about 600,000 have had the operation thus far. Even a skilled surgeon takes about 15 minutes, most African countries are desperately short of surgeons, and there is no Mohels Without Borders.
So donors are pinning their hopes on several devices now being tested to speed things up.
Dr. Stefano Bertozzi, director of H.I.V. for the Bill and Melinda Gates Foundation, said it had its eyes on two, named PrePex and the Shang Ring, and was supporting efforts by the World Health Organization to evaluate them.
Circumcision is believe to protect heterosexual men because the foreskin has many Langerhans cells, which pick up viruses and "present" them to the immune system - which H.I.V. attacks.
PrePex, invented in 2009 by four Israelis after one of them, a urologist, heard an appeal for doctors to do circumcisions in Africa, was approved by the Food and Drug Administration three weeks ago. The W.H.O. will make a decision on it soon, said Mitchell Warren, an AIDS-prevention expert who closely follows the process.
From the initial safety studies done so far, PrePex is clearly faster, less painful and more bloodless than any of its current rivals. And it relies on the simplest and least-threatening technology - a rubber band.
The band compresses the foreskin against a plastic ring slipped inside it; the foreskin dies within hours for lack of blood and, after a week, falls off or can be clipped off "like a fingernail," said Tzameret Fuerst, the company's chief executive officer, who compared the process to the stump of an umbilical cord's shriveling up and dropping off a few days after it is clamped.
It is done with topical anesthetic cream, and there is usually no bleeding. And PrePex can be put in place and removed by nurses with about three days' training.
No anesthesia. No blood. No sutures. No sterile settings. In 2007, the World Health Organization and UNAIDS proved that circumcised men reduce their risk of HIV Infection by approximately 60% in high risk areas such as Sub-Saharan Africa.
The Circ MedTech team developed the patent pending PrePex device to achieve rapid scale-up of male circumcision (MC) in resource limited settings, prevalent in Sub-Saharan Africa. PrePex is the first known device to facilitate non-surgical medical adult MC that can claim all of the following: No injected anesthesia. No blood. No sutures. No sterile settings.
Written and revised by
David Cohen, M.D.
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The guiding principle of the company is to offer safe, simple, scalable and cost effective adult male circumcision programs that can be implemented by minimally skilled healthcare workers. Learn more about the device Features & Benefits.
The PrePex device is FDA cleared and certified CE Mark Class IIa and is manufactured using USP Class VI biocompatible elastomeric materials compliant to ISO_13485 Medical Devices (Quality Management systems) and FDA, 21 CFR177. 2600. Circ MedTech is ISO 13485 certified.
The rings come in five sizes, A through E, Ms. Fuerst said, "and you won't believe how high-tech the rubber band is." Each size must apply just enough pressure to cut off blood flow without being tight enough to cause pain.
The W.H.O., Mr. Warren said, is also evaluating the Shang Ring, a plastic two-ring clamp developed in China to treat conditions in which the foreskin becomes so tight that it cuts off urination.
However, it requires cutting off the excess foreskin beyond the clamp, which means the circumciser must inject anesthetics directly into the penis and groin, wait for them to take effect, create a sterile surgical field and be trained in minor surgery.
"The Shang is not as fast, but it's faster than full-fledged surgery," Mr. Warren said. "And it hasn't submitted as much safety data."
In a safety study presented at an AIDS conference last month, scientists from Rwanda's health ministry said they had used PrePex to circumcise 590 men. Only two had "moderate" complications; one was fixed with a single suture, and one required a new band in a different spot.
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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.
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The Tara KLamp, manufactured in Malaysia since the 1990s, has created controversy in South Africa. It is a hinged plastic bracket the size of a small drinking cup. A plastic tube goes over the head of the penis, and the foreskin is pulled up it and painfully crushed by the bracket. Then the whole contraption must be worn at least five days. A 2005 clinical trial in South Africa was stopped early after the device caused far more injuries and infections than surgery did.
The national health ministry has banned it in most of South Africa, but it is still used heavily in KwaZulu-Natal Province, which has the country's highest AIDS rate and where the Zulu king, Goodwill Zwelithini, reversing 200 years of tradition, ordered that all Zulu men circumcised.
The W.H.O. knows about the stopped trial and is not considering the KLamp, Mr. Warren said.
Plan to circumcise 2 million using new devise complete The government plans to circumcise two million men in the next two years in an ambitious mass program that aims to reduce HIV transmission rate by 50 percent.
This follows successful trials of a non-surgical method of male circumcision called Prepex which experts say is easy to use and appropriate for the rural settings. Male circumcision has traditionally been performed surgically.
Prepex device is a simple non-surgical method that requires no sterile setting, no injected anesthesia, and it’s a bloodless procedure with no need for sutures.
PrePex has an elastic mechanism that fits closely around an inner ring, trapping the foreskin, which dries up and is removed a week after the placement of the device.
"The Ministry of Health has carried out clinical trials to evaluate this new device for one and a half years," said Dr Vincent Mutabazi, the lead investigator in the PrePex clinical trials in Rwanda. “After three major clinical trials required by the World Health Organization technical advisory group that reviews innovations on male circumcision devices, we see strong and compelling evidence on the safety, superiority over surgical circumcision and simplicity in the hand of lower cadre health practitioners like nurses.”
Dr. Reed said he had heard that another device, Ali's Klamp, was being tested in Kenya under protocols that seemed to match W.H.O. requirements. According to Circlist.com, a circumcision information Web site, it is a Turkish device dating to 2007, and works on principles similar to those of the Tara KLamp and another device, the SmartKlamp, approved by the F.D.A. in 2004.
PrePex was cleared by the F.D.A. because it was judged "substantially equivalent" to the SmartKlamp, Ms. Fuerst said. Proving equivalence in safety to an approved device is the fastest way to get approval, she said, although the technology is quite different.
PrePex's ultimate cost is still being negotiated with donor agencies and foundations, Ms. Fuerst said, but may end up in the $15-to-$20 range, about the same as a surgical circumcision kit.
### By DONALD G. McNEIL Jr.
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