Randomized Trial of the Shang Ring for Adult Male Circumcision With Removal at One to Three Weeks: Delayed Removal Leads to Detachment

Barone, Mark A. DVM, MS*; Awori, Quentin D. MBChB; Li, Philip S. MD; Simba, Raymond O. MBChB, MMed§; Weaver, Mark A. PhD; Okech, Jairus O. KRCHN§; Aduda, Alex O. KRCHN§; Cherutich, Peter MBChB, MPH; Muraguri, Nicholas MBChB, MPH; Wekesa, John Masasabi MBChB, MMed#; Nyanchoka, Jared MBChB; Perchal, Paul MA*; Masson, Puneet MD; Lee, Richard; Goldstein, Marc MD‡,**; Kioko, Jackson MBChB, ICHB/MPH, MSc, MCPM††; Lusi, Ojwang' MBChB, MMed, Dip.HSM#; Sokal, David C. MD

JAIDS Journal of Acquired Immune Deficiency Syndromes: 1 July 2012 - Volume 60 - Issue 3 - p e82–e89
doi: 10.1097/QAI.0b013e31824ea1f2
Epidemiology and Prevention

Objectives: To assess healing with Shang Ring removal at different prespecified times; whether spontaneous detachment occurs with delayed removal; problems, complaints, and acceptability of wearing the device; satisfaction among participants; and acceptability of the procedure among providers.

Methods: Fifty HIV-negative men underwent a Shang Ring circumcision in Kenya. Men were randomly assigned for device removal at 7 (15 men), 14 (15 men), or 21 days (20 men). Follow-up visits were at 7, 14, 21, 28, and 42 days after circumcision and 2 days after removal.

Results: Circumcision and device removal were conducted without significant problems. Mean times for circumcision and device removal were 6.5 (SD = 2.4) and 2.5 (SD = 0.8) minutes, respectively. Complete detachment of the device occurred in 22 (66.7%) men who wore it more than 7 days. Seven men (14.0%) with partial detachments requested removal 8–14 days postcircumcision due to pain/discomfort. Healing progressed normally in all participants; cumulative probabilities of complete healing were similar across groups. No severe or serious adverse events occurred. Acceptability among participants was high. Providers reported that Shang Ring circumcision was “very easy” compared with the forceps-guided procedure.

Conclusion: The Shang Ring is safe and easy to use according to label instructions (7 day removal). Detachments occurred without significant problems, although some men requested removal of partially detached rings. Removal time had little effect on healing. These data help allay concerns about men not returning for ring removal and expand the evidence base suggesting the Shang Ring could facilitate rapid male circumcision rollout in sub-Saharan Africa.

*EngenderHealth, New York, NY

EngenderHealth, Nairobi, Kenya

Center for Male Reproductive Medicine and Microsurgery, Department of Urology, Weill Cornell Medical College, New York, NY

§Homa Bay District Hospital, Homa Bay, Kenya

FHI360, Durham, NC

National AIDS and STI Control Programme, Nairobi, Kenya

#Ministry of Medical Services, Nairobi, Kenya

**The Population Council, New York, NY

††Ministry of Public Health and Sanitation, Nairobi, Kenya.

Correspondence to: Dr Mark A. Barone, EngenderHealth, 440 Ninth Avenue, 13th Floor, New York, NY 10001 (e-mail: mbarone@engenderhealth.org).

Support from a grant to FHI360 from the Bill & Melinda Gates Foundation to conduct research on the Shang Ring in collaboration with EngenderHealth and Weill Cornell Medical College.

Parts of these data were presented at the following meetings: University of Nairobi Collaborative HIV/AIDS Research Group Annual Meeting, January 17–21, 2011, Nairobi, Kenya; at the First Biennial National HIV and AIDS Research Conference, May 18–20, 2011, Nairobi, Kenya; and at the 6th IAS Conference on HIV Pathogenesis, Treatment, and Prevention, July 17–20, 2011, Rome, Italy.

The views expressed are those of the authors and do not necessarily reflect those of the Bill & Melinda Gates Foundation, FHI360, EngenderHealth, or Weill Cornell Medical College.

Received September 15, 2011

Accepted January 17, 2012

© 2012 Lippincott Williams & Wilkins, Inc.