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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 Int’l AIDS Conference, Vienna, Austria. Overview.
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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 Int’l AIDS Conference, Vienna, Austria
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? 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
Inside of foreskin Shang Ring (China) Marketed in China since 2005 Unique feature: eversion 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 KeXue 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 KeXue 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
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 IdealDisposableDevice 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