Put a Ring on it: How the Shang Ring Might Accelerate MC Programs Dr. David C. Sokal, FHI Dr. Fred Ndede & Dr. Mark Barone, EngenderHealth Dr. Philip S. Li, & Dr. Marc Goldstein, Weill Cornell Medical College July 21, 2010 XVIII Int’l AIDS Conference, Vienna, Austria Abstract: Title: Put a Ring on it: How the Shang Ring might Help Accelerate MC Programs Authors: Dr. David C. Sokal, FHI; Dr. Fred Ndede & Dr. Mark Barone, EngenderHealth, Dr. Philip S. Li & Dr. Marc Goldstein, Weill Cornell Medical College. Abstract: Conventional surgical techniques for adult male circumcision are time-consuming and require significant training and surgical skills. Infant circumcisions with devices are much easier than surgical methods and have only rare adverse effects. A device for adult circumcision could potentially improve surgical results and facilitate the scale-up of adult circumcision. The Shang Ring is a promising device for adult circumcision that has been on the market in China since 2005. It is faster than standard surgical techniques, with a total procedure time of about 9 minutes compared to 19 and 26 minutes for forceps-guided procedures with and without electrocautery for hemostasis, respectively. In post-training questionnaires, clinicians from Kenya and Zambia who have trained in China on Shang Ring procedures have judged that the Shang Ring is much easier than standard surgical procedures; and results of a pilot study in Kenya suggest that clients prefer the Shang Ring procedure. After obtaining ethical clearance in the US, we have submitted two protocols to national authorities for additional studies of the Shang Ring, including a randomized controlled trial comparing the Shang Ring to standard surgical methods. 1

Overview Why a device? Potential benefits of Shang Ring Introducing Shang Ring in Africa With support from the Bill & Melinda Gates Foundation In collaboration with…

Why a Device? Infant devices Adult devices? Well studied in neonates Adult Gomco Infant devices Well studied in neonates E.g.: Gomco quick & easy Injuries very rare Adult devices? Different physiology/ little data Sutures needed for adult Gomco Tara: poor results in one trial Tara Clamp

Shang Ring (China) Marketed in China since 2005 Unique feature: eversion of foreskin Inside of foreskin Shang Ring Conventional MC Traditional suture technique

Potential Benefits per Chinese data Potential advantages Shorter procedure */** Less pain** Fewer complications** Easier to train providers Potential disadvantages Multiple device sizes Shang Ring stays on for 7 to 10 days Need to confirm clinical profile in other settings * Cheng, Y. et al. (2009). A recommendable standard protocol of adult male circumcision with the Chinese Shang Ring: outcomes of 328 cases in China. Natl J Andr , Zhonghua Nan Ke Xue 15(7), 584-92. ** LI HN, et al. (2010). Shang Ring Male Circumcision versus Conventional Surgical Procedures: Comparison of Clinical Effectiveness. Natl J Andr, Zhonghua Nan Ke Xue 16(4):325-327.

Potential Benefits for Programs More acceptable Quicker

MOVE Times: Forceps-Guided & Shang Ring * “…cautery can reduce AMC time by 5–8 minutes…” MOVE, WHO, p. 33.

Introducing the Shang Ring in Africa: Kenya Pilot study, Kenya, 2009 40 men with intensive follow-up EngenderHealth: Mark Barone, Fred Ndede; Cornell: Philip Li, Marc Goldstein MOH: Homa Bay District Hospital National AIDS/STD Control Programme Ministry of Health, Kenya and Ministry of Medical Services, Kenya Results: Poster #MOPE0331 (manuscript in prep.) 100% would recommend Shang Ring to others Post-study visit anecdotal reports: Highly acceptable & preferred: shorter surgery / less pain Excellent cosmetic results Applause for Cornell & EngenderHealth & Mark Barone who couldn’t be here, and Dr. Fred Ndede on EH’s Kenya staff, and their whole Kenya team!

Training in Ningbo, China: June 2009 to June 2010

Training in Ningbo, China: Trainees’ Opinions Five Kenyan clinicians (June 2009 / May 2010) & Five Zambian clinicians (June 2010) were trained in Ningbo, China Opinions of Shang Ring from 8 participants: How easy is Shang Ring vs standard surgical? Much easier (7/8) Easier (1/8) Would you recommend Shang Ring for your country? Yes – very strongly (8/8) “Easy to train others, less bleeding, less time taken and therefore more patients can be circumcised in a day.” “It’s a new technique, quicker procedure, it leaves a nice cosmetic mark, less blood loss”

Further Clinical Evaluation of Shang Ring WHO meeting on MC devices, March 2009, Nairobi => guiding our clinical trial strategy

Planned Research Submitted for Ethical Review Time to removal: N = 50, Homa Bay, Nyanza, Kenya What happens if a man returns late for removal? Will Shang Ring detach by itself? => Possible resource savings Weekly follow-up / randomized to removal at 1, 2 or 3 weeks Randomized controlled trial: N= 400, Lusaka, Zambia & Homa Bay, Kenya How does Shang Ring compare with standard surgery? 100 Shang Ring and 100 Standard surgery @ each site Pain, acceptability to clients, acceptability to surgeons, safety, cost

What we know: Shang Ring … is quicker than surgical is easier for providers has potential for faster training & task shifting was safe & acceptable / preferred by men in Homa Bay, Kenya Might it revolutionize adult MC if planned trials confirm these data?

Thank You! Comments? Questions? Yangquan Rock of Danxia Mt. Guangdong Province, China

What Is the Ideal Disposable Device for Adult Male Circumcision ? Safe, easy to use and quick to learn No general anesthesia No suturing required Less pain Less bleeding No electric cautery Fewer complications Quick wound healing Minimally invasive Good cosmetic results Smaller size, low cost and disposable It can be performed easily and safely by minimally experienced healthcare providers