title: Clinical trials using the Shang Ring device for male circumcision in Africa: a review.
abstract: Male circumcision (MC) reduces the risk of HIV and other sexually transmitted infections (STIs), including human papillomavirus (HPV) and herpes simplex virus type 2 (HSV-2), and is recommended as an important component of a comprehensive package of HIV prevention interventions. While computer modeling has demonstrated that substantial reductions in HIV could be achieved with rapid scale-up of MC services in sub-Saharan Africa, scale-up has lagged due to scarcity of trained providers coupled with relative technical difficulty of recommended surgical MC techniques. Simplified techniques, such as devices, have the potential to allow for a more rapid roll-out of MC. One such device is the Shang Ring, a novel disposable MC device that eliminates the need for suturing and has been on the Chinese market since 2005. Results from Chinese studies have demonstrated that the Shang Ring is both safe and easy to use. Since 2008, a series of studies using the Shang Ring for adult MC have been carried out in Kenya, Uganda and Zambia, according to guidelines established by World Health Organization (WHO) for clinical evaluation of new devices for adult MC. These include a proof of concept study, a study of delayed removal of the Shang Ring, two studies comparing Shang Ring circumcision to conventional surgical approaches, and a large field trial to evaluate safety of Shang Ring circumcision during routine service delivery. Results from these studies demonstrate that the Shang Ring has an excellent safety profile and that Shang Ring circumcision is relatively easy to teach and learn, making Shang Ring MC an appealing technique for use in sub-Saharan Africa where doctors are in short supply and non-physician providers such as nurses and clinical officers are playing a major role in providing MC through task shifting. Shang Ring MC and device removals were uneventfully performed by trained nurses and clinical officers, who preferred the Shang Ring to conventional surgical techniques. Adverse event rates were similar to those observed with conventional surgical circumcision and were managed with, at most, minor interventions, resolving with no long-term sequale. Perhaps one of the biggest advantages of the Shang Ring is the relatively short 3-6 minutes procedure time. Importantly, men also preferred the Shang Ring compared to conventional circumcision and satisfaction with cosmetic appearance of their circumcised penis was very high. The vast majority of participants in studies in Africa as well as China have reported few problems and little disruption to daily life while wearing the device. The Shang Ring holds great promise as an innovative technology that has the potential to facilitate the safe and effective scale-up of circumcision services in settings where MC is not widely used and where the burden of HIV-disease is high.
authors.affiliation: 1 EngenderHealth, New York, NY, USA ; 2 Center for Male Reproductive Medicine and Microsurgery, Department of Urology, Weill Cornell Medical College, New York, NY, USA ; 3 EngenderHealth, Nairobi, Kenya.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Barone
authors.affiliation: 1 EngenderHealth, New York, NY, USA ; 2 Center for Male Reproductive Medicine and Microsurgery, Department of Urology, Weill Cornell Medical College, New York, NY, USA ; 3 EngenderHealth, Nairobi, Kenya.
authors.forename: Philip S
authors.initials: PS
authors.lastname: Li
authors.affiliation: 1 EngenderHealth, New York, NY, USA ; 2 Center for Male Reproductive Medicine and Microsurgery, Department of Urology, Weill Cornell Medical College, New York, NY, USA ; 3 EngenderHealth, Nairobi, Kenya.
authors.forename: Quentin D
authors.initials: QD
authors.lastname: Awori
authors.affiliation: 1 EngenderHealth, New York, NY, USA ; 2 Center for Male Reproductive Medicine and Microsurgery, Department of Urology, Weill Cornell Medical College, New York, NY, USA ; 3 EngenderHealth, Nairobi, Kenya.
authors.forename: Richard
authors.initials: R
authors.lastname: Lee
authors.affiliation: 1 EngenderHealth, New York, NY, USA ; 2 Center for Male Reproductive Medicine and Microsurgery, Department of Urology, Weill Cornell Medical College, New York, NY, USA ; 3 EngenderHealth, Nairobi, Kenya.
authors.forename: Marc
authors.initials: M
authors.lastname: Goldstein
keywords: HIV prevention; Shang Ring; male circumcision (MC)
references.citation: Nat Rev Urol. 2010 Nov;7(11):638-42
references.pmid: 20938437
references.citation: Sex Transm Infect. 2013 May;89(3):262-6
references.pmid: 23112341
references.citation: Clin Infect Dis. 2011 Dec;53 Suppl 3:S64-78
references.pmid: 22080271
references.citation: Int J Cancer. 2013 Sep 1;133(5):1247-52
references.pmid: 23400966
references.citation: J Acquir Immune Defic Syndr. 2013 Aug 15;63(5):617-21
references.pmid: 23614991
references.citation: BMC Infect Dis. 2011 Sep 26;11:253
references.pmid: 21943076
references.citation: J Acquir Immune Defic Syndr. 2013 Oct 1;64(2):130-3
references.pmid: 23599013
references.citation: Int J Cancer. 2012 Apr 15;130(8):1888-97
references.pmid: 21618520
references.citation: Urology. 2010 Oct;76(4):810-4
references.pmid: 20434760
references.citation: Asian J Androl. 2008 May;10(3):447-54
references.pmid: 18385906
references.citation: Am J Obstet Gynecol. 2009 Jan;200(1):42.e1-7
references.pmid: 18976733
references.citation: BMC Infect Dis. 2007 Mar 13;7:16
references.pmid: 17355625
references.citation: PLoS Med. 2010 Jul 20;7(7):e1000309
references.pmid: 20652013
references.citation: Lancet. 2007 Feb 24;369(9562):643-56
references.pmid: 17321310
references.citation: Lancet. 2007 Feb 24;369(9562):657-66
references.pmid: 17321311
references.citation: Int J STD AIDS. 1996 Oct;7(6):410-4
references.pmid: 8940669
references.citation: PLoS Med. 2005 Nov;2(11):e298
references.pmid: 16231970
references.citation: S Afr Med J. 2009 Mar;99(3):163-9
references.pmid: 19563093
references.citation: Sex Transm Dis. 2012 Feb;39(2):104-13
references.pmid: 22249298
references.citation: J Acquir Immune Defic Syndr. 2013 Oct 1;64(2):e11
references.pmid: 24047972
references.citation: PLoS Med. 2009 Sep;6(9):e1000109
references.pmid: 19901974
references.citation: J Infect Dis. 2010 May 15;201(10):1463-9
references.pmid: 20370481
references.citation: Urology. 2011 Jul;78(1):174-9
references.pmid: 21310470
references.citation: Zhonghua Nan Ke Xue. 2010 Apr;16(4):325-7
references.pmid: 20626160
references.citation: Zhonghua Nan Ke Xue. 2009 Jul;15(7):584-92
references.pmid: 19694369
references.citation: Science. 2008 May 9;320(5877):749-50
references.pmid: 18467575
references.citation: J Acquir Immune Defic Syndr. 2011 May 1;57(1):e7-12
references.pmid: 21346586
references.citation: J Acquir Immune Defic Syndr. 2012 Sep 1;61(1):49-55
references.pmid: 22739133
references.citation: PLoS One. 2008 May 21;3(5):e2212
references.pmid: 18493593
references.citation: J Acquir Immune Defic Syndr. 2014 Apr 1;65(4):447-55
references.pmid: 24583615
references.citation: PLoS One. 2008 Aug 06;3(8):e2679
references.pmid: 18682725
references.citation: Urol Int. 2007;78(3):235-40
references.pmid: 17406133
references.citation: J Acquir Immune Defic Syndr. 2012 Jul 1;60(3):e82-9
references.pmid: 22343180
references.citation: AIDS. 2012 Mar 13;26(5):609-15
references.pmid: 22210632
references.citation: Lancet. 2011 Jan 15;377(9761):209-18
references.pmid: 21216000
references.citation: Lancet. 2008 Aug 16;372(9638):585-99
references.pmid: 18687456
references.citation: PLoS Med. 2011 Nov;8(11):e1001132
references.pmid: 22140367
references.citation: AIDS. 2008 Mar 12;22(5):567-74
references.pmid: 18316997
references.citation: J Infect Dis. 2009 Jan 1;199(1):14-9
references.pmid: 19086814
references.citation: Lancet. 1999 Nov 20;354(9192):1813-5
references.pmid: 10577659
references.citation: AIDS. 2008 Sep 12;22(14):1841-50
references.pmid: 18753931