title: Field study of adult male circumcision using the ShangRing in routine clinical settings in Kenya and Zambia.
abstract: 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.affiliation: *FHI 360, Durham, NC; †Center for Male Reproductive Medicine and Surgery, Department of Urology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY; ‡University Teaching Hospital, Lusaka, Zambia; §EngenderHealth, Kisumu, Kenya; ‖Impact Research and Development Organization, Kisumu, Kenya; ¶Homa Bay District Hospital, Homa Bay, Kenya; #Zambia Prevention, Care and Treatment Partnership (ZPCT), FHI 360, Lusaka, Zambia; and **EngenderHealth, New York, NY.
authors.forename: David C
authors.initials: DC
authors.lastname: Sokal
authors.forename: Philip S
authors.initials: PS
authors.lastname: Li
authors.forename: Robert
authors.initials: R
authors.lastname: Zulu
authors.forename: Quentin D
authors.initials: QD
authors.lastname: Awori
authors.forename: Kawango
authors.initials: K
authors.lastname: Agot
authors.forename: Raymond O
authors.initials: RO
authors.lastname: Simba
authors.forename: Stephanie
authors.initials: S
authors.lastname: Combes
authors.forename: Richard K
authors.initials: RK
authors.lastname: Lee
authors.forename: Catherine
authors.initials: C
authors.lastname: Hart
authors.forename: Jaim J
authors.initials: JJ
authors.lastname: Lai
authors.forename: Zude
authors.initials: Z
authors.lastname: Zyambo
authors.forename: Marc
authors.initials: M
authors.lastname: Goldstein
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Feldblum
authors.forename: Mark A
authors.initials: MA
authors.lastname: Barone
mesh_terms: D000293:Adolescent; D000328:Adult; D002944:Circumcision, Male / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D015658:HIV Infections / Q000517:prevention & control; D006801:Humans; D007630:Kenya; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D014945:Wound Healing; D055815:Young Adult; D015024:Zambia