National AIDS/STD Control Programme Ministry of Health, Kenya and Ministry of Medical Services, Kenya Pilot Study of the Shang Ring: A Novel Male Circumcision.

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Presentation transcript:

National AIDS/STD Control Programme Ministry of Health, Kenya and Ministry of Medical Services, Kenya Pilot Study of the Shang Ring: A Novel Male Circumcision Device for HIV Prevention Mark A. Barone, DVM, MS Senior Medical Associate EngenderHealth Eastern and Southern Africa Region: Country Update Meeting Arusha, Tanzania June 2010

National AIDS/STD Control Programme Ministry of Health, Kenya and Ministry of Medical Services, Kenya The Shang Ring

National AIDS/STD Control Programme Ministry of Health, Kenya and Ministry of Medical Services, Kenya 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.

National AIDS/STD Control Programme Ministry of Health, Kenya and Ministry of Medical Services, Kenya Ring Removal after 7-10 days 1. Remove the outer ring. 2. Carefully pull back the inner ring from the edge of the wound. 3. Cut the inner ring in two places with special scissors.

National AIDS/STD Control Programme Ministry of Health, Kenya and Ministry of Medical Services, Kenya 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.

National AIDS/STD Control Programme Ministry of Health, Kenya and Ministry of Medical Services, Kenya Study Design Prospective, non-comparative study. Ethical approvals from the Cornell & Kenyatta National Hospital IRBs. Homa Bay Nairobi Recruited 40 HIV-negative men ages 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.

National AIDS/STD Control Programme Ministry of Health, Kenya and Ministry of Medical Services, Kenya Shang Ring Procedures Circumcision Mean time (minutes)4.8 ± 2.0 Difficulties with procedure0 Necessary to make small cut in foreskin4 Complications during surgery0 Removal Mean time (minutes)3.9 ± 2.6 Difficulties with removal due to pain1 Mean greatest pain during removal4.9 ± 2.5 Mean pain after removal complete2.2 ± 1.8

National AIDS/STD Control Programme Ministry of Health, Kenya and Ministry of Medical Services, Kenya Adverse Events There were no serious, severe or moderate AEs There were 6 mild AEs Adverse Event# Cases Edema2 Infection - pain & swelling, no purulent discharge 1 Minor cutaneous injury while with ring in place 3

National AIDS/STD Control Programme Ministry of Health, Kenya and Ministry of Medical Services, Kenya Device Hazard Day 7 Day 21 3 device hazards – all were partial detachment of the ring between the 2 and 7 day visits, no treatment required

National AIDS/STD Control Programme Ministry of Health, Kenya and Ministry of Medical Services, Kenya Participants Experience & Satisfaction (Day 7) Greatest pain during erection with ring (mean) 3.5 ± 2.3 Back to work34 (85.0%) Little to no disruption of sleep29 (72.5%) Little to no disruption of daily activities38 (95.0%) Satisfaction with circumcision –Very satisfied –Somewhat satisfied 36 (90.0%) 4 (10.0%) Would recommend Shang Ring40 (100.0%)

National AIDS/STD Control Programme Ministry of Health, Kenya and Ministry of Medical Services, Kenya 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.

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

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