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Grant Details

Grant Number: 5R01CA114773-05 Interpret this number
Primary Investigator: Smith, Jennifer
Organization: Univ Of North Carolina Chapel Hill
Project Title: Effect of Male Circumcision on Penile HPV Infection
Fiscal Year: 2009
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Abstract

DESCRIPTION (provided by applicant): Human papillomavirus (HPV) is the central cause of invasive cervical cancer (ICC) in women, and other anogenital cancers, including anal, penile, vaginal and vulvar cancers. Public health intervention strategies are needed to reduce the genital acquisition of high-risk HPV types to prevent these cancers that affect women and men. Given that men are important in transmitting HPV to their female sexual partners, interventions that reduce HPV acquisition and persistence in men could be an important HPV prevention strategy benefiting both men and women. Limited cross-sectional data suggest that male circumcision may reduce the carriage of penile HPV infection. However, proof that male circumcision reduces HPV penile infection acquisition and/or persistence can only be obtained through the conduct of a prospective, randomized clinical trial (RCT). The University of North Carolina, in collaboration with the UNIM (Universities of Nairobi, Illinois and Manitoba Reproductive Health Project) Male Health Clinic, The University of Illinois at Chicago, the University of Nairobi, the Albert Einstein College of Medicine in New York City, and the Vrije Universiteit Medical Center in Amsterdam proposes to study of the effect of male circumcision on the risk and natural history of penile HPV infection in young, sexually active men in Kisumu, Kenya. This proposed study of penile HPV infection is nested within an ongoing "parent" RCT to assess the effect of male circumcision in reducing HIV incidence in 18-24 year-old men in Kisumu that began in February 2002. This HPV project proposes to determine the type-specific HPV DNA prevalence in penile exfoliated cell samples currently being collected as part of the ongoing RCT of male circumcision. An estimated 2,442 men are expected to contribute penile exfoliated cell specimens from two anatomical sites (the shaft and glans/coronal sulcus). These sample are being collected at enrollment and at the 6-, 12-, 18- and 24- month follow-up visits. Specimens will be tested using a sensitive PCR assay to detect a wide-range of HPV DNA types. HPV viral load of samples positive for HPV types 16, 18, 31, 33 and 45 will be determined using a real-time PCR. A new clinical examination (a visual inspection with 3% acetic acid and aided magnification) will be added to this ongoing RCT at the final 24-month visit to determine the presence of penile lesions (i.e., flat lesions, papular lesions, or condolymata acuminate). Study results will provide the most definitive evidence to date regarding the effect of male circumcision on HPV infection and penile lesions in men. If male circumcision is found to be effective and safe in reducing HPV infection or penile lesions in men, it could in turn reduce HPV prevalence and associated cervical neoplasia in women.

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Publications

Higher HPV16 and HPV18 Penile Viral Loads Are Associated With Decreased Human Papillomavirus Clearance in Uncircumcised Kenyan Men.
Authors: Senkomago V. , Backes D.M. , Hudgens M.G. , Poole C. , Meshnick S.R. , Agot K. , Moses S. , Snijders P.J. , Meijer C.J. , Hesselink A.T. , et al. .
Source: Sexually transmitted diseases, 2016 09; 43(9), p. 572-8.
PMID: 27513384
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Acquisition and persistence of human papillomavirus 16 (HPV-16) and HPV-18 among men with high-HPV viral load infections in a circumcision trial in Kisumu, Kenya.
Authors: Senkomago V. , Backes D.M. , Hudgens M.G. , Poole C. , Agot K. , Moses S. , Snijders P.J. , Meijer C.J. , Hesselink A.T. , Schlecht N.F. , et al. .
Source: The Journal of infectious diseases, 2015-03-01; 211(5), p. 811-20.
EPub date: 2014-09-26.
PMID: 25261492
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Risk of HIV acquisition among circumcised and uncircumcised young men with penile human papillomavirus infection.
Authors: Rositch A.F. , Mao L. , Hudgens M.G. , Moses S. , Agot K. , Backes D.M. , Nyagaya E. , Snijders P.J. , Meijer C.J. , Bailey R.C. , et al. .
Source: AIDS (London, England), 2014-03-13; 28(5), p. 745-52.
PMID: 24149088
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Growing evidence that HPV infection is associated with an increase in HIV acquisition: exploring the issue of HPV vaccination.
Authors: Rositch A.F. , Gravitt P.E. , Smith J.S. .
Source: Sexually transmitted infections, 2013 Aug; 89(5), p. 357.
PMID: 23858496
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Knowledge, attitudes, practices, and perceived risk of cervical cancer among Kenyan women: brief report.
Authors: Sudenga S.L. , Rositch A.F. , Otieno W.A. , Smith J.S. .
Source: International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, 2013 Jun; 23(5), p. 895-9.
PMID: 23694983
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Sexual behaviour and less frequent bathing are associated with higher human papillomavirus incidence in a cohort study of uncircumcised Kenyan men.
Authors: Backes D.M. , Snijders P.J. , Hudgens M.G. , Bailey R.C. , Bogaarts M. , Agot K. , Agingu W. , Moses S. , Meijer C.J. , Smith J.S. .
Source: Sexually transmitted infections, 2013 Mar; 89(2), p. 148-55.
EPub date: 2012-09-01.
PMID: 22941862
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Vaccine-relevant human papillomavirus (HPV) infections and future acquisition of high-risk HPV types in men.
Authors: Rositch A.F. , Hudgens M.G. , Backes D.M. , Moses S. , Agot K. , Nyagaya E. , Snijders P.J. , Meijer C.J. , Bailey R.C. , Smith J.S. .
Source: The Journal of infectious diseases, 2012-09-01; 206(5), p. 669-77.
EPub date: 2012-06-18.
PMID: 22711906
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Male circumcision is associated with a lower prevalence of human papillomavirus-associated penile lesions among Kenyan men.
Authors: Backes D.M. , Bleeker M.C. , Meijer C.J. , Hudgens M.G. , Agot K. , Bailey R.C. , Ndinya-Achola J.O. , Hayombe J. , Hogewoning C.J. , Moses S. , et al. .
Source: International journal of cancer, 2012-04-15; 130(8), p. 1888-97.
EPub date: 2011-08-02.
PMID: 21618520
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Multiple human papillomavirus infections and type competition in men.
Authors: Rositch A.F. , Poole C. , Hudgens M.G. , Agot K. , Nyagaya E. , Moses S. , Snijders P.J. , Meijer C.J. , Bailey R.C. , Smith J.S. .
Source: The Journal of infectious diseases, 2012-01-01; 205(1), p. 72-81.
EPub date: 2011-11-04.
PMID: 22058418
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Discrete-time semi-Markov modeling of human papillomavirus persistence.
Authors: Mitchell C.E. , Hudgens M.G. , King C.C. , Cu-Uvin S. , Lo Y. , Rompalo A. , Sobel J. , Smith J.S. .
Source: Statistics in medicine, 2011-07-30; 30(17), p. 2160-70.
EPub date: 2011-05-03.
PMID: 21538985
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Age-specific prevalence of human papillomavirus infection in males: a global review.
Authors: Smith J.S. , Gilbert P.A. , Melendy A. , Rana R.K. , Pimenta J.M. .
Source: The Journal of adolescent health : official publication of the Society for Adolescent Medicine, 2011 Jun; 48(6), p. 540-52.
PMID: 21575812
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HPV vaccine acceptability among Kenyan women.
Authors: Becker-Dreps S. , Otieno W.A. , Brewer N.T. , Agot K. , Smith J.S. .
Source: Vaccine, 2010-07-12; 28(31), p. 4864-7.
EPub date: 2010-06-04.
PMID: 20566394
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Increased risk of HIV acquisition among Kenyan men with human papillomavirus infection.
Authors: Smith J.S. , Moses S. , Hudgens M.G. , Parker C.B. , Agot K. , Maclean I. , Ndinya-Achola J.O. , Snijders P.J. , Meijer C.J. , Bailey R.C. .
Source: The Journal of infectious diseases, 2010-06-01; 201(11), p. 1677-85.
PMID: 20415595
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Prevalence and risk factors of human papillomavirus infection by penile site in uncircumcised Kenyan men.
Authors: Smith J.S. , Backes D.M. , Hudgens M.G. , Bailey R.C. , Veronesi G. , Bogaarts M. , Agot K. , Ndinya-Achola J.O. , Maclean I. , Agingu W. , et al. .
Source: International journal of cancer, 2010-01-15; 126(2), p. 572-7.
PMID: 19626601
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Herpes simplex virus type 2 antibody detection performance in Kisumu, Kenya, using the Herpeselect ELISA, Kalon ELISA, Western blot and inhibition testing.
Authors: Smith J.S. , Bailey R.C. , Westreich D.J. , Maclean I. , Agot K. , Ndinya-Achola J.O. , Hogrefe W. , Morrow R.A. , Moses S. .
Source: Sexually transmitted infections, 2009 Apr; 85(2), p. 92-6.
EPub date: 2008-10-27.
PMID: 18955387
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Human papillomavirus detection by penile site in young men from Kenya.
Authors: Smith J.S. , Moses S. , Hudgens M.G. , Agot K. , Franceschi S. , Maclean I.W. , Ndinya-Achola J.O. , Parker C.B. , Pugh N. , Meijer C.J. , et al. .
Source: Sexually transmitted diseases, 2007 Nov; 34(11), p. 928-34.
PMID: 17621251
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