BACKGROUND: Circumcision devices can facilitate adult voluntary medical male circumcision programs for HIV prevention. The World Health Organization recommends field studies to confirm the safety of devices in local settings. METHODS: We evaluated the safety of the ShangRing device in routine service delivery by measuring adverse event (AE) rates overall and by HIV status. We enrolled men aged 18-54 years and scheduled them for 2 post-circumcision follow-up visits at day 7 for device removal and days 35-42. Men were examined to document AEs and healing and to ascertain client acceptability. Provider preferences were also assessed. RESULTS: We enrolled 1163 men (557 in Kenya and 606 in Zambia); the as-treated analysis population comprised 1149 men, including 84 HIV-positive men. There were no serious AEs and 2 severe AEs: 1 severe wound dehiscence and 1 severe pain, both of which resolved with treatment. There were 18 moderate/severe AEs among 16 men (1.4% of men; 95% confidence interval: 0.8% to 2.3%). The most common AE was wound dehiscence (9 men, 0.8%). Healing was similar between HIV-infected and uninfected men, with 85.7% and 87.3% completely healed at days 35-42. Most men (94.8%) were very satisfied with post-circumcision appearance of the penis, and almost all would recommend a ShangRing procedure. Nineteen of 21 providers preferred the ShangRing over conventional surgery. CONCLUSIONS: The ShangRing has an excellent safety profile with few hemorrhagic and infectious complications. The ShangRing is well accepted by clients and preferred by providers, making it a potential boon to the scale-up of adult voluntary medical male circumcision in African countries.
BACKGROUND: Circumcision devices can facilitate adult voluntary medical male circumcision programs for HIV prevention. The World Health Organization recommends field studies to confirm the safety of devices in local settings. METHODS: We evaluated the safety of the ShangRing device in routine service delivery by measuring adverse event (AE) rates overall and by HIV status. We enrolled men aged 18-54 years and scheduled them for 2 post-circumcision follow-up visits at day 7 for device removal and days 35-42. Men were examined to document AEs and healing and to ascertain client acceptability. Provider preferences were also assessed. RESULTS: We enrolled 1163 men (557 in Kenya and 606 in Zambia); the as-treated analysis population comprised 1149 men, including 84 HIV-positive men. There were no serious AEs and 2 severe AEs: 1 severe wound dehiscence and 1 severe pain, both of which resolved with treatment. There were 18 moderate/severe AEs among 16 men (1.4% of men; 95% confidence interval: 0.8% to 2.3%). The most common AE was wound dehiscence (9 men, 0.8%). Healing was similar between HIV-infected and uninfected men, with 85.7% and 87.3% completely healed at days 35-42. Most men (94.8%) were very satisfied with post-circumcision appearance of the penis, and almost all would recommend a ShangRing procedure. Nineteen of 21 providers preferred the ShangRing over conventional surgery. CONCLUSIONS: The ShangRing has an excellent safety profile with few hemorrhagic and infectious complications. The ShangRing is well accepted by clients and preferred by providers, making it a potential boon to the scale-up of adult voluntary medical male circumcision in African countries.
Authors: Stephanie M Davis; Helen Baker; Jessica M Gross; Sharon L Leslie; Cynthia M Z Chasokela; Julia Samuelson; Carlos Toledo Journal: J Assoc Nurses AIDS Care Date: 2021 Jan-Feb 01 Impact factor: 1.809
Authors: Quentin D Awori; Richard K Lee; Phillip S Li; Jared N Moguche; Dan Ouma; Betsy Sambai; Marc Goldstein; Mark A Barone Journal: J Int AIDS Soc Date: 2017-07-12 Impact factor: 5.396
Authors: Quentin D Awori; Richard K Lee; Philip S Li; Robert Zulu; Kawango Agot; Stephanie Combes; Raymond O Simba; Catherine Hart; Jaim Jou Lai; Zude Zyambo; Marc Goldstein; Paul J Feldblum; Mark A Barone Journal: J Acquir Immune Defic Syndr Date: 2016-06-01 Impact factor: 3.731
Authors: Mark A Barone; Philip S Li; Robert Zulu; Quentin D Awori; Kawango Agot; Stephanie Combes; Raymond O Simba; Richard K Lee; Catherine Hart; Jaim Jou Lai; Zude Zyambo; Marc Goldstein; Paul J Feldblum; David C Sokal Journal: J Acquir Immune Defic Syndr Date: 2016-06-01 Impact factor: 3.731