Pilot Study of the Shang Ring: A Novel Male Circumcision Device for HIV Prevention

1. Pilot Study of the Shang Ring: A Novel Male Circumcision Device for HIV Prevention Eastern and Southern Africa Region: Country Update Meeting Arusha, Tanzania June 2010 Mark A. Barone, DVM, MSSenior Medical AssociateEngenderHealth

2. The Shang Ring

3. Shang Ring Circumcision 1. Measure the penis with special measuring tape. 2. After inner ring is placed over the penis, grasp edges of the foreskin. 3. Flip the foreskin over the inner ring 4. Cut the foreskin on the underside of the device. 5. The device in place.

4. Ring Removal after 7-10 days 2. Carefully pull back the inner ring from the edge of the wound. 1. Remove the outer ring. 3. Cut the inner ring in two places with special scissors.

5. Pilot Study Objectives • Examine clinical outcomes and patient satisfaction in a small sample of Kenyan men to assess: • Safety • Efficacy (in terms of successful circumcision) • Acceptability/satisfaction • Lay the groundwork for other clinical studies in Africa since the device had not been used outside of China before.

6. Nairobi Homa Bay Study Design • Prospective, non-comparative study. • Ethical approvals from the Cornell & Kenyatta National Hospital IRBs. • Recruited 40 HIV-negative men ages 18-54 years seeking circumcision at the Homa Bay District Hospital. • Follow-up exams: day 2, 7, 9,14, 21, 28, 35, 42. • Interviews on day 0, 7 and 42. • Data collected from Oct - Dec 2009.

7. Shang Ring Procedures

8. Adverse Events • There were no serious, severe or moderate AEs • There were 6 mild AEs

9. Device Hazard 3 device hazards – all were partial detachment of the ring between the 2 and 7 day visits, no treatment required Day 7 Day 7 Day 21

10. Participant’s Experience & Satisfaction (Day 7)

11. Conclusions • The results show that the Shang Ring is safe to use in further studies in African settings. • Providers found the device easy to use and reported no problems with use of the device. • The Shang Ring was acceptable among the study population.

12. Planned Studies • Time to Removal Study • evaluate healing with removal at 1, 2 and 3 weeks • determine whether spontaneous detachment occurs • Randomized controlled trials • compare the Shang Ring with WHO-recommended methods to assess pain, acceptability, wound healing, surgical difficulties and adverse events • assess comparative costs • Demonstration Projects • describe Shang Ring use in routine clinical settings • use enhanced surveillance to identify rare adverse events

13. Study Partners EngenderHealth Fred Ndede, MB ChB, MMed Paul Perchal, MA George Odingo, MPH Rosemary Were Billard Orambo Weill Cornell Medical College Philip Li, MD Marc Goldstein, MD Puneet Masson, MD Howard Kim, MD Richard Lee, MD National AIDS/STD Control Programme, Kenya Nicholas Muraguri, MB ChB, MPH Peter Cherutich, MB ChB, MPH Ministry of Medical Services, Kenya John Masasabi Wekesa MB ChB, MMed Homa Bay District Hospital Quentin Awori, MD Jairus Okech, KRCHN