Circumcision devices eyed in HIV prevention

Now that male circumcision has been associated with a lower risk for HIV infection in international observational studies and in three randomized controlled clinical trials, international health officials are looking at options in making it more available to men at risk.1-3

Researchers are looking at two potential devices, the PrePex and the Shang Ring. Both of the devices are minimally invasive, with no need for hemostasis or suturing, making the procedures quicker and easier to perform, even by non-surgeons, and potentially safer and more acceptable to patients. Data from studies of these devices recently were presented at the 16th International Conference on AIDS and STIs in Africa in Addis Ababa, Ethiopia.4,5 (Why are such devices needed? See the information, below.)

Rings minimize bleeding

The Shang Ring, manufactured by Wu Hu SNNDA Medical Treatment Appliance Technology Co., Wu Hu City, China, is a disposable circumcision device consisting of two concentric plastic rings. The foreskin is everted over the inner ring before application of the outer ring, and then the foreskin is cut off from the underside using scissors. Hemostasis provided by compression of the foreskin between the locking rings prevents bleeding and averts the need for sutures.

The Shang Ring is similar to the Plastibell device that is widely used in the United States for infant male circumcision in that it remains on the penis after the procedure. While the Plastibell device falls off after several days, the Shang Ring stays on longer, because adults heal more slowly than infants. Labeling for the device recommends removal of the Shang Ring on the seventh day after it is administered.6

A randomized controlled trial was conducted at Nyanza, Kenya's Homa Bay District Hospital and the Society for Family Health's New Start YWCA Male Circumcision Centre in Lusaka, Zambia. The trial was conducted to compare the use of the device with conventional surgery. At each site, 198 men seeking male circumcision randomly were assigned to be circumcised by surgeons using the Shang Ring or the conventional technique. Preliminary results of the trial show that rates of complications from the surgery were low and similar in both groups. All complications experienced with the Shang Ring were mild or moderate and were resolved with conservative management, researchers note.4 Use of the Shang Ring reduced the average time it took to perform the procedure from 20 minutes to 7 minutes in Kenya and to 6.5 minutes in Zambia. All of the procedures in Zambia and about half of the procedures in Kenya were performed by nurses or clinical officers rather than physicians.4

The Bill & Melinda Gates Foundation is funding research evaluating the Shang Ring, confirms Julie Bernstein, a senior communications officer with the organization. The foundation also supports the World Health Organization's efforts to evaluate and provide guidance on the safety and efficacy of male circumcision devices, she notes.

FHI 360, a Research Triangle Park, NC-based human development organization, and its collaborators are thankful for the Gates Foundation's support and are encouraged by the results of their Shang Ring research, says David Sokal, MD, FHI 360 scientist and principal investigator for the Shang Ring grant. "Men prefer the improved cosmetic results compared to the results after suturing, and providers have told us it's much easier than conventional surgery," Sokal comments.

PrePex eyed in trials

The PrePex device, developed by Circ MedTech of the British Virgin Islands, uses a special elastic mechanism that fits closely around an inner ring to trap the foreskin in between. No anesthesia, sutures, or sterile settings are required, say its developers. Once the foreskin necrotizes, the device is safely removed in a week, and the necrotic foreskin is cut off.

To assess the safety and effectiveness of male circumcision using the PrePex device, researchers recruited 10 Rwandan nurses who had no prior experience performing male circumcisions. The nurses were trained for three days and then used the device to circumcise 590 men in a procedure that required no injected anesthesia.

All of the procedures were performed successfully, with two resulting in device-related complications. No serious complications were reported, and all were resolved easily, researchers report. The device has the potential to facilitate rapid, safe scale-up of male circumcision performed by healthcare providers who are not physicians, researchers conclude.5

It is "remarkable" how quickly those who have been trained in device use can perform procedures with minimal adverse effects, says Steven Kaplan, MD, a urologist at Weill Cornell Medical College. Kaplan, who is serving as a co-investigator in PrePex research, says he believes the procedure can be done by healthcare extenders with very good success.

While the PrePex device has received 510k marketing clearance in the United States by the Food and Drug Administration, there are no current plans to bring it to the U.S. market.

"The company has no plans for the U.S. market," says John Keaten, a spokesperson for the Acumen Fund in New York City, a nonprofit venture firm that has invested in Circ MedTech. "It is strictly focused on voluntary adult male circumcision for HIV prevention in resource-limited settings."

The World Health Organization has established an independent advisory committee to systematically review data from circumcision studies. Research of the Shang Ring and the PrePex devices are part of a series of assessments designed to establish the safety, effectiveness, and acceptability of adult male circumcision devices in different settings before public health officials proceed with more widespread implementation in sub-Saharan Africa.7

References

  1. Auvert B, Taljaard D, Lagarde E, et al. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med 2005; 2(11):e298.
  2. Bailey RC, Moses S, Parker CB, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet 2007; 369:643-656.
  3. Gray RH, Kigozi G, Serwadda D, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet 2007; 369:657-666.
  4. Awori Q, Barone M, Li P, et al. Evaluation of the Shang Ring: a device-assisted method for providing voluntary medical male circumcision in Kenya. Presented at the 16th International Conference on AIDS and STIs in Africa. Addis Ababa, Ethiopia; December 2011.
  5. Bitega JP, Ngeruka ML, Hategekimana T, et al. Safety and efficacy of the PrePex device for rapid scale-up of male circumcision for HIV
  6. prevention in resource-limited settings. J Acquir Immune Defic Syndr 2011; 58:e127-134.
  7. Innovative device could transform delivery of male circumcision. MCC News 2011. Accessed at http://bit.ly/wOtXUB.
  8. Studies of devices yield promising results. MCC News 2011. Accessed at http://bit.ly/zwc6bB.

What is the reason devices are needed?

While circumcision might not be a "silver bullet" in addressing the international AIDS epidemic, public health officials consider it a critical component in the HIV prevention "toolkit," particularly in such hard-hit regions as sub-Saharan Africa.1 Findings from an analysis of 14 priority countries in eastern and southern Africa indicate that by increasing male circumcision services to cover 80% of all adult men and newborn boys between 2009 and 2015, more than 4 million new adult HIV infections could be averted at a cost of $2.5 billion.2

A dilemma lies in the shortage of providers trained to perform a classical circumcision. Even if men can be gathered to perform circumcisions, each procedure takes about 15 to 20 minutes in the hands of a skilled surgeon, and most African countries are desperately short of such healthcare professionals.3

References

  1. Wamai RG, Morris BJ, Bailis SA, et al. Male circumcision for HIV prevention: current evidence and implementation in sub-Saharan Africa. J Int AIDS Soc 2011; 14:49.
  2. USAID Health Policy Initiative. The potential cost and impact of expanding male circumcision in 14 African countries. Accessed at http://bit.ly/wV3fa4.
  3. McNeil DG. AIDS prevention inspires ways to make circumcisions easier. New York Times; Jan. 30, 2012. Accessed at http://nyti.ms/x0bvyy.