TY - JOUR
T1 - Effect of circumcision of HIV-negative men on transmission of human papillomavirus to HIV-negative women
T2 - A randomised trial in Rakai, Uganda
AU - Wawer, Maria J.
AU - Tobian, Aaron Ar
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.
AU - Chen, Michael Z.
AU - Reynolds, Steven J.
AU - Quinn, Thomas C.
AU - Gray, Ronald H.
N1 - Funding Information:
The study was funded by the Bill & Melinda Gates Foundation (22006.02) and the National Institutes of Health (U1AI51171) . The Fogarty International Center (5D43TW001508 and 2D43TW000010-19-AITRP) contributed to training. National Institute of Allergy and Infectious Diseases (NIAID), NIH grants (U01-A1-068613 and 3U01-AI075115-03S1) and NIAID Intramural Program provided laboratory support. AART was supported by the Johns Hopkins University Clinician Scientist Award. We thank the study participants and the Rakai Community Advisory Board whose commitment and cooperation made this study possible. We thank Edward M'bidde, Director, Uganda Virus Research Institute, for his continuing support, and Renee Ridzon of the Bill & Melinda Gates Foundation and Melanie Bacon of National Institutes of Health for their assistance with the trial.
Funding Information:
PEG received research funding from Roche Molecular Diagnostics, who manufacture the HPV genotyping test used in this study. The other authors declare that they have no conflicts of interest.
PY - 2011
Y1 - 2011
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.
AB - 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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U2 - 10.1016/S0140-6736(10)61967-8
DO - 10.1016/S0140-6736(10)61967-8
M3 - Article
C2 - 21216000
AN - SCOPUS:78651414245
SN - 0140-6736
VL - 377
SP - 209
EP - 218
JO - The Lancet
JF - The Lancet
IS - 9761
ER -