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AIDS Prevention Inspires Ways to Make Circumcisions Easier




 

The New York Times - January 30, 2012

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.

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.

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.

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.

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.

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.



 


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Information in this article was accurate in January 30, 2012. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.