title: Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial.
abstract: BACKGROUND
  Ecological and observational studies suggest that male circumcision reduces the risk of HIV acquisition in men. Our aim was to investigate the effect of male circumcision on HIV incidence in men.
  
  
  METHODS
  4996 uncircumcised, HIV-negative men aged 15-49 years who agreed to HIV testing and counselling were enrolled in this randomised trial in rural Rakai district, Uganda. Men were randomly assigned to receive immediate circumcision (n=2474) or circumcision delayed for 24 months (2522). HIV testing, physical examination, and interviews were repeated at 6, 12, and 24 month follow-up visits. The primary outcome was HIV incidence. Analyses were done on a modified intention-to-treat basis. This trial is registered with ClinicalTrials.gov, with the number NCT00425984.
  
  
  RESULTS
  Baseline characteristics of the men in the intervention and control groups were much the same at enrollment. Retention rates were much the same in the two groups, with 90-92% of participants retained at all time points. In the modified intention-to-treat analysis, HIV incidence over 24 months was 0.66 cases per 100 person-years in the intervention group and 1.33 cases per 100 person-years in the control group (estimated efficacy of intervention 51%, 95% CI 16-72; p=0.006). The as-treated efficacy was 55% (95% CI 22-75; p=0.002); efficacy from the Kaplan-Meier time-to-HIV-detection as-treated analysis was 60% (30-77; p=0.003). HIV incidence was lower in the intervention group than it was in the control group in all sociodemographic, behavioural, and sexually transmitted disease symptom subgroups. Moderate or severe adverse events occurred in 84 (3.6%) circumcisions; all resolved with treatment. Behaviours were much the same in both groups during follow-up.
  
  
  CONCLUSIONS
  Male circumcision reduced HIV incidence in men without behavioural disinhibition. Circumcision can be recommended for HIV prevention in men.
authors.affiliation: Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD 21215, USA. rgray@jhsph.edu
authors.forename: Ronald H
authors.initials: RH
authors.lastname: Gray
authors.forename: Godfrey
authors.initials: G
authors.lastname: Kigozi
authors.forename: David
authors.initials: D
authors.lastname: Serwadda
authors.forename: Frederick
authors.initials: F
authors.lastname: Makumbi
authors.forename: Stephen
authors.initials: S
authors.lastname: Watya
authors.forename: Fred
authors.initials: F
authors.lastname: Nalugoda
authors.forename: Noah
authors.initials: N
authors.lastname: Kiwanuka
authors.forename: Lawrence H
authors.initials: LH
authors.lastname: Moulton
authors.forename: Mohammad A
authors.initials: MA
authors.lastname: Chaudhary
authors.forename: Michael Z
authors.initials: MZ
authors.lastname: Chen
authors.forename: Nelson K
authors.initials: NK
authors.lastname: Sewankambo
authors.forename: Fred
authors.initials: F
authors.lastname: Wabwire-Mangen
authors.forename: Melanie C
authors.initials: MC
authors.lastname: Bacon
authors.forename: Carolyn F M
authors.initials: CF
authors.lastname: Williams
authors.forename: Pius
authors.initials: P
authors.lastname: Opendi
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Reynolds
authors.forename: Oliver
authors.initials: O
authors.lastname: Laeyendecker
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Quinn
authors.forename: Maria J
authors.initials: MJ
authors.lastname: Wawer
mesh_terms: D000293:Adolescent; D000328:Adult; D002944:Circumcision, Male / Q000009:adverse effects*; D017280:Condoms / Q000706:statistics & numerical data; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016012:Poisson Distribution; D014454:Uganda / Q000453:epidemiology