The Acceptability and Safety of the Shang Ring for Adult Male Circumcision in Rakai, Uganda. Godfrey Kigozi, Richard Musoke, Stephen Watya, Nehemiah Kighoma, Paschal Ssebbowa, David Serwadda, Fred Nalugoda, Frederick Makumbi, Philip Richard Lee, Marc Goldstein, Nelson Sewankambo, Maria Wawer, Ronald Gray

Background and Methods One of the constraints on Voluntary medical male circumcision (VMMC) service delivery is the time required for conventional surgery which limits the number of procedures per provider in a day. We assessed the acceptability and safety of the Shang Ring device relative to conventional surgery (dorsal slit) HIV-negative men aged 18 or more years who requested free VMMC were informed about the Shang Ring and dorsal slit surgical procedures. 47% (621/1322) of the men who came for pre-surgery assessment consented to study enrollment and were asked to choose one method. Men were followed at 7 days postoperatively to assess adverse events (AEs) related to surgery and to remove the Shang Ring. They were provided with acetaminophen tablets for postoperative pain control. Participants were followed up at 4 weeks postoperatively to ascertain late onset AEs and to assess wound healing.

Key findings 621 men were enrolled, 508 (81.8%) chose the Shang Ring and 113 the dorsal slit. The Shang Ring was provided to 504 men, among whom there were 4 failures of Ring placement (0.8%) which required surgical hemostasis and wound closure. 117 men received dorsal slit due to lack or ring size for 4 men who chose Shang. Surgery-related AEs were moderate; 2 post surgery pain, 1 bleeding, 1 insufficient skin removal and 1 wound dehiscence,1.0% (1.8% with device failure) compared to (0.8%) among dorsal slit men. Complete healing at 4 weeks was 84% with the Ring and 100% with dorsal slit. Resumption of sex before 4 weeks was 7.0% with the Ring and 15.0% dorsal slit The mean time for surgery was 6.1 minutes with the Ring and 17.7 minutes with the dorsal slit. Mean time for Ring removal was 2.2 minutes. Three men (0.6%) self removed the Shang Ring, one on day 5 and 2 on day 8. The wounds had healed well by week 4.

Important implications. The Shang Ring appears to be an acceptable and safe method of VMMC in rural Africa. Its introduction into VMMC programs could markedly reduce the time required for surgery and might increase the efficiency of VMMC services. Back up surgical facilities are needed in case of failures of ring placement, phimosis/tight skin or in case of lack of ring size. Wound healing is slower with the Shang Ring compared to the dorsal slit. Need for emphasis to delay resumption of sex until 6 weeks/complete healing. The need to return after ~ I week for Shang Ring removal adds to program burden. There is need to train and certify providers in device placement in order to minimize AEs. Ring displacements occurred in cases done earlier in the study. Need to do safety and acceptability studies among adolescents. Failure of Ring placement and adverse events related to surgery RESULTS Details of postoperative surgery-related adverse events

Acknowledgements NIAID/NIH – Funded the study Study Participants Rakai Health Sciences study team Forgaty ATRIP Training program