Robert C. Bailey Stephen Moses University of Illinois at Chicago University of Manitoba

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The Protective Effect of Adult Male Circumcision against HIV Acquisition Is Sustained for at least 54 Months: Results from the Kisumu, Kenya Trial. Robert C. Bailey Stephen Moses University of Illinois at Chicago University of Manitoba Corette Parker Kawango Agot
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The Protective Effect of Adult Male Circumcision against HIV Acquisition Is Sustained for at least 54 Months: Results from the Kisumu, Kenya Trial Robert C. Bailey Stephen Moses University of Illinois at Chicago University of Manitoba Corette Parker Kawango Agot RTI International Impact Research & Development Ian Maclean John Krieger University of Manitoba University of Washington J.O. Ndinya-Achola Carolyn Williams University of Nairobi Div of AIDS, NIAID, NIH Supported by Division of AIDS, NIAID, National Institutes of Health and the Canadian Institutes of Health Research Background HIV Acquisition Is Sustained for at least 54 Months: Results from the Kisumu, Kenya Trial
  • Previously, we reported findings from our randomized controlled trial of male circumcision to reduce HIV incidence in 18 – 24 year-olds
  • 60% protective effect against HIV acquisition in modified intent to treat analysis
  • December 12, 2006 NIAID was advised by the DSMB to unblind the study.
  • December 15, 2006, we began offering circumcision to the controls.
  • Remaining participants were reconsented for continued follow-up beginning March, 2007
  • Objective HIV Acquisition Is Sustained for at least 54 Months: Results from the Kisumu, Kenya Trial
  • To report results from continued follow-up of circumcised and uncircumcised men up to 54 months post-randomization.
  • Methods - Follow-up HIV Acquisition Is Sustained for at least 54 Months: Results from the Kisumu, Kenya Trial
  • 2784 men ages 18 -24 years randomized to circumcision or delayed circumcision.
  • All participants: HIV testing, behavioural questionnaire, medical examination, STD testing and HIV prevention counselling at baseline and every 6 months thereafter.
  • HIV testing: double parallel rapid tests; ELISA and sensitive PCR for confirmation
  • Circumcised men: Post-operative check-ups at 3, 8 and 30 days after the procedure.
  • From December 15, 2006, controls have been offered circumcision.
  • Methods - Statistical Analyses HIV Acquisition Is Sustained for at least 54 Months: Results from the Kisumu, Kenya Trial
  • Chi-square tests / Fisher’s exact tests for categorical data
  • One-way analysis of variance for ordinal measures
  • Kaplan-Meier estimates and Cox proportional hazards models for HIV status with time
  • RESULTS HIV Acquisition Is Sustained for at least 54 Months: Results from the Kisumu, Kenya Trial Number of HIV Seroconversions HIV Acquisition Is Sustained for at least 54 Months: Results from the Kisumu, Kenya Trialby Month of Study through 24 MonthsModified Intent-to-treat Incidence in Circumcision = 1.8% Incidence in Controls = 4.0% RR = 0.40 (0.23, 0.69) Continued Follow-up December, 2006 – March, 2010 HIV Acquisition Is Sustained for at least 54 Months: Results from the Kisumu, Kenya Trial
  • 1740 men eligible to consent to extended follow-up
  • 1552 (89%) consented
  • 767 circumcision group
  • 785 control group
  • 1469 (95%) remain on study
  • 49% (387/795) of those in control group have been circumcised
  • Baseline Characteristics of Controls: HIV Acquisition Is Sustained for at least 54 Months: Results from the Kisumu, Kenya Trial 619 Circumcised vs 774 Uncircumcised Baseline Characteristics of Controls: Circumcised vs Uncircumcised
  • No differences in controls who circumcised versus controls who remained uncircumcised in:
  • Demographics
  • Physical characteristics
  • Laboratory results for STIs
  • Sexual histories
  • No differences versus circumcision group.
  • Cumulative HIV Seroincidence over 54 Months: Circumcision Group versus Controls when Not Circumcised RR = 0.36 [0.24, 0.55] M12 M24 M36 M48 M54 Number of HIV Seroconversions Group versusby Month of StudyThrough 54 Months of Follow-up Incidence in Circumcision = 4.0% Incidence in Controls = 10.6% RR = 0.36 (0.24, 0.55) Seroconversions by Month of Study Group versusThrough 54 Months of Follow-upAs Treated RR = 0.34 [0.23, 0.51] Annualized Incidence Group versus p = 0.0007 # per 100 person- years Uncirced Estimated Cumulative Incidence [95% CI] Group versus by Study Visit VisitCircumcisedUncircumcisedp-value M30 1.7% [1.1, 2.7] 5.1% [3.8, 6.6] p<0.0001 M36 2.0% [1.3, 3.1] 6.6% [5.0, 8.6] p<0.0001 M42 2.6% [1.8, 3.9] 7.5% [5.8, 9.8] p<0.0001 M48 3.3% [2.3, 4.8] 8.9% [6.9, 11.5] p<0.0002 M54 4.0% [2.8, 5.7] 10.6% [8.2, 13.6] p<0.0002 Limitations Group versus
  • The random assignment has been broken.
  • Fewer men remain in the study than originally enrolled.
  • Fewer person-years of exposure accrue at each interval since the trial was unblinded.
  • Many of those eligible for delayed circumcision have not yet opted to be circumcised (49%).
  • Conclusions Group versus
  • The 60% protective effect of circumcision against HIV acquisition found in sexually active men in Kisumu, Kenya over 24 months is clearly sustained, and possibly strengthened, over 4.5 years of study.
  • These results provide further support for policy makers, donors and implementers to scale up comprehensive, safe, voluntary medical male circumcision in appropriate regions as rapidly as possible.
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