Transcript how the Shang Ring might accelerate MC programs

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?
• Infant devices
Adult Gomco
– 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
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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
Results:
National AIDS/STD Control Programme
Ministry of Health, Kenya
and
Ministry of Medical Services, Kenya
•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: 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
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
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 ?
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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