Circumcision in HIV-infected men and its effect on HIV transmission to female partners in Rakai, Uganda: a randomised controlled trial
- PMID: 19616720
- PMCID: PMC2905212
- DOI: 10.1016/S0140-6736(09)60998-3
Circumcision in HIV-infected men and its effect on HIV transmission to female partners in Rakai, Uganda: a randomised controlled trial
Abstract
Background: Observational studies have reported an association between male circumcision and reduced risk of HIV infection in female partners. We assessed whether circumcision in HIV-infected men would reduce transmission of the virus to female sexual partners.
Methods: 922 uncircumcised, HIV-infected, asymptomatic men aged 15-49 years with CD4-cell counts 350 cells per microL or more were enrolled in this unblinded, randomised controlled trial in Rakai District, Uganda. Men were randomly assigned by computer-generated randomisation sequence to receive immediate circumcision (intervention; n=474) or circumcision delayed for 24 months (control; n=448). HIV-uninfected female partners of the randomised men were concurrently enrolled (intervention, n=93; control, n=70) and followed up at 6, 12, and 24 months, to assess HIV acquisition by male treatment assignment (primary outcome). A modified intention-to-treat (ITT) analysis, which included all concurrently enrolled couples in which the female partner had at least one follow-up visit over 24 months, assessed female HIV acquisition by use of survival analysis and Cox proportional hazards modelling. This trial is registered with ClinicalTrials.gov, number NCT00124878.
Findings: The trial was stopped early because of futility. 92 couples in the intervention group and 67 couples in the control group were included in the modified ITT analysis. 17 (18%) women in the intervention group and eight (12%) women in the control group acquired HIV during follow-up (p=0.36). Cumulative probabilities of female HIV infection at 24 months were 21.7% (95% CI 12.7-33.4) in the intervention group and 13.4% (6.7-25.8) in the control group (adjusted hazard ratio 1.49, 95% CI 0.62-3.57; p=0.368).
Interpretation: Circumcision of HIV-infected men did not reduce HIV transmission to female partners over 24 months; longer-term effects could not be assessed. Condom use after male circumcision is essential for HIV prevention.
Funding: Bill & Melinda Gates Foundation with additional laboratory and training support from the National Institutes of Health and the Fogarty International Center.
Conflict of interest statement
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Comment in
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Male circumcision and HIV risks and benefits for women.Lancet. 2009 Jul 18;374(9685):182-4. doi: 10.1016/S0140-6736(09)61311-8. Lancet. 2009. PMID: 19616704 No abstract available.
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Male circumcision and risk of HIV in women.Lancet. 2009 Oct 31;374(9700):1497-8; author reply 1498. doi: 10.1016/S0140-6736(09)61898-5. Lancet. 2009. PMID: 19880009 No abstract available.
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Male circumcision for prevention of HIV transmission.Lancet. 2009 Oct 31;374(9700):1497. doi: 10.1016/S0140-6736(09)61897-3. Lancet. 2009. PMID: 19880010 No abstract available.
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Male circumcision for prevention of HIV transmission.Lancet. 2009 Oct 31;374(9700):1497. doi: 10.1016/S0140-6736(09)61896-1. Lancet. 2009. PMID: 19880011 No abstract available.
References
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- Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007;369(9562):643–656. - PubMed
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- Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007;369(9562):657–666. - PubMed
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- WHO/UNAIDS. New Data on Male Circumcision and HIV Prevention: Policy and Programme Implications. 2007. Ref Type: Report.
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