title: Randomized trial of the Shang Ring for adult male circumcision with removal at one to three weeks: delayed removal leads to detachment.
abstract: OBJECTIVE
  To assess healing with Shang Ring removal at different prespecified times; whether spontaneous detachment occurs with delayed removal; problems, complaints, and acceptability of wearing the device; satisfaction among participants; and acceptability of the procedure among providers.
  
  
  METHODS
  Fifty HIV-negative men underwent a Shang Ring circumcision in Kenya. Men were randomly assigned for device removal at 7 (15 men), 14 (15 men), or 21 days (20 men). Follow-up visits were at 7, 14, 21, 28, and 42 days after circumcision and 2 days after removal.
  
  
  RESULTS
  Circumcision and device removal were conducted without significant problems. Mean times for circumcision and device removal were 6.5 (SD = 2.4) and 2.5 (SD = 0.8) minutes, respectively. Complete detachment of the device occurred in 22 (66.7%) men who wore it more than 7 days. Seven men (14.0%) with partial detachments requested removal 8-14 days postcircumcision due to pain/discomfort. Healing progressed normally in all participants; cumulative probabilities of complete healing were similar across groups. No severe or serious adverse events occurred. Acceptability among participants was high. Providers reported that Shang Ring circumcision was "very easy" compared with the forceps-guided procedure.
  
  
  CONCLUSIONS
  The Shang Ring is safe and easy to use according to label instructions (7 day removal). Detachments occurred without significant problems, although some men requested removal of partially detached rings. Removal time had little effect on healing. These data help allay concerns about men not returning for ring removal and expand the evidence base suggesting the Shang Ring could facilitate rapid male circumcision rollout in sub-Saharan Africa.
authors.affiliation: EngenderHealth, New York, NY 10001, USA. mbarone@engenderhealth.org
authors.forename: Mark A
authors.initials: MA
authors.lastname: Barone
authors.forename: Quentin D
authors.initials: QD
authors.lastname: Awori
authors.forename: Philip S
authors.initials: PS
authors.lastname: Li
authors.forename: Raymond O
authors.initials: RO
authors.lastname: Simba
authors.forename: Mark A
authors.initials: MA
authors.lastname: Weaver
authors.forename: Jairus O
authors.initials: JO
authors.lastname: Okech
authors.forename: Alex O
authors.initials: AO
authors.lastname: Aduda
authors.forename: Peter
authors.initials: P
authors.lastname: Cherutich
authors.forename: Nicholas
authors.initials: N
authors.lastname: Muraguri
authors.forename: John Masasabi
authors.initials: JM
authors.lastname: Wekesa
authors.forename: Jared
authors.initials: J
authors.lastname: Nyanchoka
authors.forename: Paul
authors.initials: P
authors.lastname: Perchal
authors.forename: Puneet
authors.initials: P
authors.lastname: Masson
authors.forename: Richard
authors.initials: R
authors.lastname: Lee
authors.forename: Marc
authors.initials: M
authors.lastname: Goldstein
authors.forename: Jackson
authors.initials: J
authors.lastname: Kioko
authors.forename: Ojwang'
authors.initials: O
authors.lastname: Lusi
authors.forename: David C
authors.initials: DC
authors.lastname: Sokal
mesh_terms: D000293:Adolescent; D000328:Adult; D002944:Circumcision, Male / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D015658:HIV Infections / Q000517:prevention & control; D018023:HIV Seronegativity; D006801:Humans; D007630:Kenya; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D013997:Time Factors; D014945:Wound Healing; D055815:Young Adult