WELBC04 - Oral Abstract
A field study of male circumcision using the Shang Ring, a minimally-invasive disposable device, in routine clinical settings in Kenya and Zambia
Presented by Mark A Barone (United States).
M.A. Barone1, P.S. Li2, R. Zulu3, Q.D. Awori4, K. Agot5, S. Combes6, R.O. Simba7, R. Lee2, C. Hart6, J.J. Lai6, Z. Zyambo8, M. Goldstein2, D.C. Sokal6
1EngenderHealth, New York, United States, 2Weill Cornell Medical College, Department of Urology, New York, United States, 3University Teaching Hospital, Lusaka, Zambia, 4EngenderHealth, Nairobi, Kenya, 5Impact Research and Development Organization, Kisumu, Kenya, 6FHI 360, Durham, United States, 7Homa Bay District Hospital, Homa Bay, Kenya, 8ZPCT, FHI 360, Lusaka, Zambia
Background: Circumcision devices have the potential to facilitate medical male circumcision (MMC) programs for HIV prevention in sub-Saharan Africa. Studies in China and Africa demonstrated advantages of the Shang Ring, a minimally-invasive disposable circumcision device, compared to conventional surgery. We conducted a non-comparative prospective field study to confirm the safety of Shang Ring circumcision during routine service delivery.
Methods: Shang Ring circumcisions were provided to men aged 18-54 years seeking MMC at 10 sites in Kenya and Zambia. Men were followed-up at 7 and 35-42 days post-circumcision.
Results: We enrolled 1,161 men, 556 in Kenya and 605 in Zambia; the as-treated analysis population included 1,149 men, 84 were HIV-positive. The overall rate of post-operative procedure-related adverse events (AEs) was 1.6% (95% CI: .93-2.46). There were no serious AEs and two severe AEs, one wound dehiscence and one post-operative pain; both resolved with treatment. Healing was similar among HIV-infected and uninfected men; 85.7% and 87.3% completely healed by the 35-42 day visit. Pain from the device caused little interference with daily life. Overall, 21.3% of men reported returning to normal activities on the day of circumcision, with 95% doing so by the third day. The mean (SD) highest degree of pain reported during an erection with the ring is place was 3.5 (1.9) on a scale of 1-10 (lowest to highest). Two men had early device removal before the scheduled day seven visit because of pain. Most men (94.8%) were very satisfied with the appearance of their circumcised penis. Almost all (98.8%) said they would recommend Shang Ring circumcision to others. Non-physicians performed 97% of the procedures; 70.5% of the circumcisions were conducted at sites without previous Shang Ring experience. There were no AEs during the circumcisions and few (1.1%) problems encountered during ring removal. Of the 19 providers, 17 preferred the Shang Ring over conventional surgery.
Conclusion: The Shang Ring was safe and easy to use in routine services. It was well liked by clients and preferred by providers. Evidence to date indicates that the Shang Ring could facilitate rapid roll-out of MMC in sub-Saharan Africa.
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