title: Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes.
abstract: OBJECTIVE
  To assess the safety, effectiveness, and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia.
  
  
  METHODS
  We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing.
  
  
  RESULTS
  Four hundred and ninety-six men comprised the analysis population, with 255 in the Standard Sizing arm and 241 in the Modified Sizing arm. Three men experienced a moderate or severe AEs (0.6%), including 2 in the Standard Sizing arm (0.8%) and 1 in the Modified Sizing arm (0.4%). 73.2% of participants were completely healed at the scheduled day 42 healing check visit, with similar percentages across study arms. Virtually all (99.6%) men, regardless of study arm, stated that they were very satisfied or satisfied with the appearance of their circumcised penis, and 98.6% stated that they would recommend ShangRing circumcision to family/friends.
  
  
  CONCLUSIONS
  The moderate/severe AE rate was low and similar in the 2 study arms, suggesting that provision of one-half the number of adult device sizes is sufficient for safe service delivery. Effectiveness, time to healing, and acceptability were similar in the study arms. The simplicity of the ShangRing technique, and its relative speed, could facilitate VMMC program goals. In addition, sufficiency of fewer device sizes would simplify logistics and inventory.
authors.affiliation: *Global Health Department, FHI 360, Durham, NC; †Department of Surgery, University Teaching Hospital, Lusaka, Zambia; ‡FHI 360, Lusaka, Zambia; and §FHI 360, Nairobi, Kenya.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Feldblum
authors.forename: Robert
authors.initials: R
authors.lastname: Zulu
authors.forename: David
authors.initials: D
authors.lastname: Linyama
authors.forename: Sarah
authors.initials: S
authors.lastname: Long
authors.forename: Thikazi Jere
authors.initials: TJ
authors.lastname: Nonde
authors.forename: Jaim Jou
authors.initials: JJ
authors.lastname: Lai
authors.forename: Joshua
authors.initials: J
authors.lastname: Kashitala
authors.forename: Valentine
authors.initials: V
authors.lastname: Veena
authors.forename: Prisca
authors.initials: P
authors.lastname: Kasonde
mesh_terms: D000293:Adolescent; D000328:Adult; D002944:Circumcision, Male / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult