IMPLEMENTATION AND OPERATIONAL RESEARCH:EPIDEMIOLOGY AND PREVENTION The Shang Ring Device for Adult Male Circumcision: A Proof of Concept Study in Kenya Mark A. Barone, DVM, MS,* Frederick Ndede, MBChB, Mmed,† Philip S. Li, MD,‡§ Puneet Masson, MD,‡ Quentin Awori, MBChB,† Jairus Okech, KRCHN, k Peter Cherutich, MBChB, MPH,¶ Nicholas Muraguri, MBChB, MPH,¶ Paul Perchal, MA,* Richard Lee, MD,‡ Howard H. Kim, MD,‡ and Marc Goldstein, MD‡§ Objective: To assess safety, preliminary efficacy, and acceptability of the Shang Ring, a novel disposable device for adult male circumcision in Kenya. Methods: Forty HIV-negative men were recruited in Homa Bay, Kenya. Circumcisions were performed by a trained physician or nurse working with 1 assistant. Follow-up was conducted at 2, 7, 9, 14, 21, 28, 35, and 42 days after circumcision. Rings were removed on day 7. Pain was assessed using avisual analog scale (VAS) (0 = no pain, 10 = worst possible). Men were interviewed at enrollment and on days 7 and 42. Results: All 40 procedures were completed successfully. Mean procedure and device removal times were 4.8 (SD 6 2.0) and 3.9 (SD 6 2.6) minutes, respectively. There were 6 mild adverse events, including 3 penile skin injuries, 2 cases of edema, and 1 infection; all resolved with conservative management. In addition, there were 3 partial ring detachments between days 2–7. None required treatment or early ring removal. Erections with the ring were well tolerated, with a mean pain score of 3.5 (SD 6 2.3). By day 2, 80% of men were back to work. At 42 days, all participants were very satisfied with their circumcision and would recommend the procedure to others. Conclusions: Our results demonstrate that the Shang Ring is safe for further study in Africa. Acceptability of the Shang Ring among participants was excellent. With short procedure times, less surgical skill required, and the ease with which it can be used by nonphysicians, the Shang Ring could facilitate rapid roll-out of male circumcision in sub-Saharan Africa. Key Words: circumcision devices, HIV prevention, male circumcision, proof of concept study (J Acquir Immune Defic Syndr 2011;57:e7–e12) INTRODUCTION Three randomized controlled trials in Kenya, Uganda, and South Africa demonstrated that male circumcision reduces the risk of men acquiring HIV by approximately 60%. 1–3 In fact, male circumcision is the only HIV prevention method shown to be consistently efficacious in reducing HIV risk. 4,5 The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS (UNAIDS) recommend that countries with low male circumcision rates, high HIV prevalence, and predominantly heterosexual epidemics, con- sider scaling-up male circumcision as part of their HIV prevention interventions. 6 A major obstacles to roll-out of adult male circumcision in sub-Saharan Africa has been the relative technical difficulty of the 3 WHO/UNAIDS-recommended surgical techniques; 7 roll-out could be greatly facilitated and accelerated with a simplified bloodless methods. 8 No devices for adult circumcision have gained widespread acceptance due to high complication rates, difficult surgical techniques, high cost, or the cumbersome nature of available devices. The Shang Ring, manufactured by Wu Hu SNNDA Medical Treatment Appliance Technology Co, LTD, Wu Hu City, China, is a novel disposable circumcision device that consists of 2 concentric plastic rings (Fig. 1). Rings are commercially available in China in 32 sizes, ranging from 9–42 mm in diameter, for use with neonates to adults. Hemostasis provided by compression of the foreskin between the locking rings minimizes bleeding and obviates the need for sutures. The design eliminates the need to make scalpel cuts directly on the penis. Results from three Chinese studies utilizing the Shang Ring have demonstrated excellent safety and use profiles, with high acceptance among study participants. Peng et al 9 reported complication rates of 0.58% bleeding, 0.67% local infection, Received for publication Ocober 18, 2010; accepted February 14, 2011. From *EngenderHealth, New York, NY; †EngenderHealth, Kenya; ‡Department of Urology, Center for Male Reproductive Medicine and Microsurgery, Weill Cornell Medical College,New York, NY; §Center for Biomedical Research, The Population Council, New York, NY; k Homa Bay District Hospital, Homa Bay, Kenya; and {National AIDS/STD Control Programme, Nairobi, Kenya. Supported by funding by EngenderHealth and Weill Cornell Medical College. No outside funding was used. Parts of these data were presented at the following meetings: Male Circumcision Evaluation and Operations Meeting, Johannesburg, South Africa, January 18–23, 2010; University of Nairobi Collaborative HIV/AIDS Research Group Annual Meeting, January 25–29, 2010, Nairobi, Kenya; Scaling-up Male Circumcision Programs in the Eastern and Southern Africa Region: Country Update Meeting, June 8–10, 2010, Arusha, Tanzania; XVIII International AIDS Conference, July 18–23, 2010, Vienna, Austria. The authors have no conflicts of interest to disclose. Correspondence to: Dr Mark A. Barone, EngenderHealth, 440 Ninth Avenue, 13th Floor, New York, NY 10001 (e-mail: mbarone@engenderhealth.org). Copyright Ó 2011 by Lippincott Williams & Wilkins J Acquir Immune Defic Syndr  Volume 57, Number 1, May 1, 2011 www.jaids.com | e7