1. 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 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

2. 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…

3. 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

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

5. 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),
** 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):

6. Potential Benefits for Programs
More
acceptable
Quicker

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

8. 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!

9. Training in Ningbo, China: June 2009 to June 2010

10. 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”

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

12. 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 each site
Pain, acceptability to clients, acceptability to surgeons, safety, cost

13. 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?

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

15. 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