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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 Intl AIDS Conference, Vienna, Austria

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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

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Why a Device? 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 Adult Gomco Tara Clamp

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

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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.

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Potential Benefits for Programs More acceptable Quicker

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MOVE Times: Forceps-Guided & Shang Ring * cautery can reduce AMC time by 58 minutes MOVE, WHO, p. 33.

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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 Introducing the Shang Ring in Africa: 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 National AIDS/STD Control Programme Ministry of Health, Kenya and Ministry of Medical Services, Kenya

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Training in Ningbo, China: June 2009 to June 2010

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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. Its a new technique, quicker procedure, it leaves a nice cosmetic mark, less blood loss

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

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Planned Research Submitted for Ethical Review 1.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 2.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

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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?

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

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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 What Is the Ideal DisposableDevice for Adult Male Circumcision ? What Is the Ideal Disposable Device for Adult Male Circumcision ?