Effect of circumcision of HIV-negative men on transmission of human papillomavirus to HIV-negative women: A randomised trial in Rakai, Uganda

Maria J. Wawer, Aaron Ar Tobian, Godfrey Kigozi, Xiangrong Kong, Patti E. Gravitt, David Serwadda, Fred Nalugoda, Frederick Makumbi, Victor Ssempiija, Nelson Sewankambo, Stephen Watya, Kevin P. Eaton, Amy E. Oliver, Michael Z. Chen, Steven J. Reynolds, Thomas C. Quinn, Ronald H. Gray

Research output: Contribution to journalArticle

Abstract

Randomised trials show that male circumcision reduces the prevalence and incidence of high-risk human papillomavirus (HPV) infection in men. We assessed the efficacy of male circumcision to reduce prevalence and incidence of high-risk HPV in female partners of circumcised men. In two parallel but independent randomised controlled trials of male circumcision, we enrolled HIV-negative men and their female partners between 2003 and 2006, in Rakai, Uganda. With a computer-generated random number sequence in blocks of 20, men were assigned to undergo circumcision immediately (intervention) or after 24 months (control). HIV-uninfected female partners (648 of men from the intervention group, and 597 of men in the control group) were simultaneously enrolled and provided interview information and self-collected vaginal swabs at baseline, 12 months, and 24 months. Vaginal swabs were tested for high-risk HPV by Roche HPV Linear Array. Female HPV infection was a secondary endpoint of the trials, assessed as the prevalence of high-risk HPV infection 24 months after intervention and the incidence of new infections during the trial. Analysis was by intention-to-treat. An as-treated analysis was also done to account for study-group crossovers. The trials were registered, numbers NCT00425984 and NCT00124878. During the trial, 18 men in the control group underwent circumcision elsewhere, and 31 in the intervention group did not undergo circumcision. At 24-month follow-up, data were available for 544 women in the intervention group and 488 in the control group; 151 (27·8) women in the intervention group and 189 (38·7) in the control group had high-risk HPV infection (prevalence risk ratio=0·72, 95 CI 0·60-0·85, p=0·001). During the trial, incidence of high-risk HPV infection in women was lower in the intervention group than in the control group (20·7 infections vs 26·9 infections per 100 person-years; incidence rate ratio=0·77, 0·63-0·93, p=0·008). Our findings indicate that male circumcision should now be accepted as an efficacious intervention for reducing the prevalence and incidence of HPV infections in female partners. However, protection is only partial; the promotion of safe sex practices is also important. The Bill & Melinda Gates Foundation, National Institutes of Health, and Fogarty International Center.

Original languageEnglish (US)
Pages (from-to)209-218
Number of pages10
JournalThe Lancet
Volume377
Issue number9761
DOIs
StatePublished - Jan 15 2011

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Uganda
Papillomavirus Infections
HIV
Male Circumcision
Incidence
Control Groups
Infection
Safe Sex
Intention to Treat Analysis
National Institutes of Health (U.S.)
Cross-Over Studies
Randomized Controlled Trials
Odds Ratio
Interviews

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Effect of circumcision of HIV-negative men on transmission of human papillomavirus to HIV-negative women : A randomised trial in Rakai, Uganda. / Wawer, Maria J.; Tobian, Aaron Ar; Kigozi, Godfrey; Kong, Xiangrong; Gravitt, Patti E.; Serwadda, David; Nalugoda, Fred; Makumbi, Frederick; Ssempiija, Victor; Sewankambo, Nelson; Watya, Stephen; Eaton, Kevin P.; Oliver, Amy E.; Chen, Michael Z.; Reynolds, Steven J.; Quinn, Thomas C.; Gray, Ronald H.

In: The Lancet, Vol. 377, No. 9761, 15.01.2011, p. 209-218.

Research output: Contribution to journalArticle

Wawer, Maria J. ; Tobian, Aaron Ar ; Kigozi, Godfrey ; Kong, Xiangrong ; Gravitt, Patti E. ; Serwadda, David ; Nalugoda, Fred ; Makumbi, Frederick ; Ssempiija, Victor ; Sewankambo, Nelson ; Watya, Stephen ; Eaton, Kevin P. ; Oliver, Amy E. ; Chen, Michael Z. ; Reynolds, Steven J. ; Quinn, Thomas C. ; Gray, Ronald H. / Effect of circumcision of HIV-negative men on transmission of human papillomavirus to HIV-negative women : A randomised trial in Rakai, Uganda. In: The Lancet. 2011 ; Vol. 377, No. 9761. pp. 209-218.
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abstract = "Randomised trials show that male circumcision reduces the prevalence and incidence of high-risk human papillomavirus (HPV) infection in men. We assessed the efficacy of male circumcision to reduce prevalence and incidence of high-risk HPV in female partners of circumcised men. In two parallel but independent randomised controlled trials of male circumcision, we enrolled HIV-negative men and their female partners between 2003 and 2006, in Rakai, Uganda. With a computer-generated random number sequence in blocks of 20, men were assigned to undergo circumcision immediately (intervention) or after 24 months (control). HIV-uninfected female partners (648 of men from the intervention group, and 597 of men in the control group) were simultaneously enrolled and provided interview information and self-collected vaginal swabs at baseline, 12 months, and 24 months. Vaginal swabs were tested for high-risk HPV by Roche HPV Linear Array. Female HPV infection was a secondary endpoint of the trials, assessed as the prevalence of high-risk HPV infection 24 months after intervention and the incidence of new infections during the trial. Analysis was by intention-to-treat. An as-treated analysis was also done to account for study-group crossovers. The trials were registered, numbers NCT00425984 and NCT00124878. During the trial, 18 men in the control group underwent circumcision elsewhere, and 31 in the intervention group did not undergo circumcision. At 24-month follow-up, data were available for 544 women in the intervention group and 488 in the control group; 151 (27·8) women in the intervention group and 189 (38·7) in the control group had high-risk HPV infection (prevalence risk ratio=0·72, 95 CI 0·60-0·85, p=0·001). During the trial, incidence of high-risk HPV infection in women was lower in the intervention group than in the control group (20·7 infections vs 26·9 infections per 100 person-years; incidence rate ratio=0·77, 0·63-0·93, p=0·008). Our findings indicate that male circumcision should now be accepted as an efficacious intervention for reducing the prevalence and incidence of HPV infections in female partners. However, protection is only partial; the promotion of safe sex practices is also important. The Bill & Melinda Gates Foundation, National Institutes of Health, and Fogarty International Center.",
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AU - Kigozi, Godfrey

AU - Kong, Xiangrong

AU - Gravitt, Patti E.

AU - Serwadda, David

AU - Nalugoda, Fred

AU - Makumbi, Frederick

AU - Ssempiija, Victor

AU - Sewankambo, Nelson

AU - Watya, Stephen

AU - Eaton, Kevin P.

AU - Oliver, Amy E.

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AU - Gray, Ronald H.

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N2 - Randomised trials show that male circumcision reduces the prevalence and incidence of high-risk human papillomavirus (HPV) infection in men. We assessed the efficacy of male circumcision to reduce prevalence and incidence of high-risk HPV in female partners of circumcised men. In two parallel but independent randomised controlled trials of male circumcision, we enrolled HIV-negative men and their female partners between 2003 and 2006, in Rakai, Uganda. With a computer-generated random number sequence in blocks of 20, men were assigned to undergo circumcision immediately (intervention) or after 24 months (control). HIV-uninfected female partners (648 of men from the intervention group, and 597 of men in the control group) were simultaneously enrolled and provided interview information and self-collected vaginal swabs at baseline, 12 months, and 24 months. Vaginal swabs were tested for high-risk HPV by Roche HPV Linear Array. Female HPV infection was a secondary endpoint of the trials, assessed as the prevalence of high-risk HPV infection 24 months after intervention and the incidence of new infections during the trial. Analysis was by intention-to-treat. An as-treated analysis was also done to account for study-group crossovers. The trials were registered, numbers NCT00425984 and NCT00124878. During the trial, 18 men in the control group underwent circumcision elsewhere, and 31 in the intervention group did not undergo circumcision. At 24-month follow-up, data were available for 544 women in the intervention group and 488 in the control group; 151 (27·8) women in the intervention group and 189 (38·7) in the control group had high-risk HPV infection (prevalence risk ratio=0·72, 95 CI 0·60-0·85, p=0·001). During the trial, incidence of high-risk HPV infection in women was lower in the intervention group than in the control group (20·7 infections vs 26·9 infections per 100 person-years; incidence rate ratio=0·77, 0·63-0·93, p=0·008). Our findings indicate that male circumcision should now be accepted as an efficacious intervention for reducing the prevalence and incidence of HPV infections in female partners. However, protection is only partial; the promotion of safe sex practices is also important. The Bill & Melinda Gates Foundation, National Institutes of Health, and Fogarty International Center.

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