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

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

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  1. 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

  2. Background • 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

  3. Objective • To report results from continued follow-up of circumcised and uncircumcised men up to 54 months post-randomization.

  4. Methods - Follow-up • 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.

  5. Methods - Statistical Analyses • 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

  6. RESULTS

  7. Number of HIV Seroconversions by 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)

  8. Continued Follow-up December, 2006 – March, 2010 • 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

  9. Baseline Characteristics of Controls: 619 Circumcised vs 774 Uncircumcised

  10. 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.

  11. 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

  12. Number of HIV Seroconversions by 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)

  13. Seroconversions by Month of StudyThrough 54 Months of Follow-upAs Treated RR = 0.34 [0.23, 0.51]

  14. Annualized Incidence p = 0.0007 # per 100 person- years Uncirced

  15. Estimated Cumulative Incidence [95% CI] 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

  16. Limitations • 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%).

  17. Conclusions • 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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