Experience with ShangRing circumcision in Malawi voluntary medical male circumcision program

BACKGROUND: Malawi has implemented voluntary medical male circumcision (VMMC) for HIV prevention since 2008. Between 2015 and 2019, the country evaluated ShangRing (collar clamp) device through pilot, active (AAES), and passive (PAES) adverse event surveillance to inform its use within the program. We present lessons learned for the period May 2015 to December 2020.
DESCRIPTION: The ShangRing device was first introduced in Malawi in 2015, through implementation pilot( n=498) in one fixed site to assess safety and acceptability among males 18 to 49 years. The device safety and acceptability were further evaluated in 10 sites under AAES from April to September 2019 (n=1862). Following favorable results, the device was endorsed in October 2019 for routine services under PAES. Since endorsement, 5,104 ShangRing circumcisions have been conducted in 15 sites (Blantyre) by December 2020, with an overall low moderate(MAEs) and severe(SAEs) adverse event (AE) rate of 0.001%(5/5104) reported. The MAEs(2) were post removal wound disruptions while SAEs(3) were ring displacements requiring surgical intervention.
LESSONS LEARNED: During the pilot phase, the AE rate was 1.4% (7/498, MAEs), and 98% (488/498) of males circumcised were happy with cosmetic outcome. During AAES, the AE rate was low (0.0005%: 1/1862,SAE) compared to the national acceptable rate (1%), and 31(82%) out of 38 ShangRing clients separately interviewed were satisfied with placement and removal procedures because of less pain experienced. ShangRing circumcision has short placement procedure time (7 minutes, AAES; 5 minutes, PAES) compared to the time taken on conventional surgical techniques (15 minutes). Key challenge associated with ShangRing circumcision is the requirement for multiple device sizes (15) leading to frequent sites stock outs.
CONCLUSIONS: ShangRing circumcision is safe, fast, and acceptable in Malawi context. It prevents potential penile glans injuries and urethral fistulas associated with deep stitches of conventional surgical techniques, especially among younger clients (10-14 years). The national program should promote ShangRing circumcision as an equivalent alternative to conventional surgical circumcision, and should scale it up to accelerate achievement of national and global prevention targets.