National AIDS/STD Control ProgrammeMinistry 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, MSSenior Medical Associate

EngenderHealth

Eastern and Southern Africa Region: Country Update Meeting

Arusha, Tanzania June 2010

National AIDS/STD Control ProgrammeMinistry of Health, Kenya

and

Ministry of Medical Services, Kenya

The Shang Ring

National AIDS/STD Control ProgrammeMinistry 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 ProgrammeMinistry 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 ProgrammeMinistry 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 ProgrammeMinistry 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 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.

National AIDS/STD Control ProgrammeMinistry of Health, Kenya

and

Ministry of Medical Services, Kenya

Shang Ring Procedures Circumcision

Mean time (minutes) 4.8 ± 2.0

Difficulties with procedure 0

Necessary to make small cut in foreskin 4

Complications during surgery 0

Removal

Mean time (minutes) 3.9 ± 2.6

Difficulties with removal due to pain 1

Mean greatest pain during removal 4.9 ± 2.5

Mean pain after removal complete 2.2 ± 1.8

National AIDS/STD Control ProgrammeMinistry 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

Edema 2

Infection - pain & swelling, no purulent discharge

1

Minor cutaneous injury while with ring in place

3

National AIDS/STD Control ProgrammeMinistry of Health, Kenya

and

Ministry of Medical Services, Kenya

Device Hazard

Day 7 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 ProgrammeMinistry of Health, Kenya

and

Ministry of Medical Services, Kenya

Participant’s Experience & Satisfaction (Day 7)

Greatest pain during erection with ring (mean) 3.5 ± 2.3

Back to work 34 (85.0%)

Little to no disruption of sleep 29 (72.5%)

Little to no disruption of daily activities 38 (95.0%)

Satisfaction with circumcision–Very satisfied–Somewhat satisfied

36 (90.0%) 4 (10.0%)

Would recommend Shang Ring 40 (100.0%)

National AIDS/STD Control ProgrammeMinistry 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 ProgrammeMinistry of Health, Kenya

and

Ministry of Medical Services, Kenya

Study PartnersWeill Cornell Medical CollegePhilip Li, MDMarc Goldstein, MDPuneet Masson, MDHoward Kim, MDRichard Lee, MD

EngenderHealthFred Ndede, MB ChB, MMedPaul Perchal, MAGeorge Odingo, MPHRosemary WereBillard Orambo

National AIDS/STD Control Programme, Kenya Nicholas Muraguri, MB ChB, MPHPeter Cherutich, MB ChB, MPH

Homa Bay District HospitalQuentin Awori, MDJairus Okech, KRCHN

Ministry of Medical Services, Kenya John Masasabi Wekesa MB ChB, MMed