Human papillomavirus (HPV), a sexually transmitted infection, is strongly associated with invasive cervical, vulvar, and anal cancers in women, and penile and anal cancers in men. Internationally, the incidence of cervical cancer varies greatly, with high rates observed in Mexico and low rates observed in the US and Europe. In the US, Hispanic women have significantly elevated rates of disease compared with non-Hispanic whites. The sexual behavior of the male partner may be as or more important than a Hispanic or Mexican woman's personal sexual behavior in predicting her risk of HPV infection and cervical disease. Unfortunately, little is known regarding the prevalence, incidence, and clearance of HPV infections in men, hampering efforts to control infection in both men and women. We propose to conduct a large binational (US-Mexico) prospective study of men, the HPV in Men Study (HIM). The goal of this revised application is to further our understanding of the natural history of HPV infection in men so that effective programs can be developed to reduce HPV disease burden in both men and women. Specifically, our aims are to enroll a cohort of 3000 men who will be examined every six months for four years, determine the incidence and persistence of type-specific penile HPV infections, the humoral immune response to HPV infection, and assess the factors independently associated with acquisition, persistence, and clearance of type-specific HPV infections in men. We hypothesize that HPV infection type distribution in men differs by country, that most infections in men are transient, and that type-specific HPV antibody response occurs only among persistently positive men. In addition, we hypothesize that current condom use and circumcision confers reduced risk of incident HPV infection, and that other sexually acquired infections increase risk. Our proposed study is unique in that it will prospectively assess HPV infection in a large cohort of men in the US and Mexico, representing countries of high and low risk. The study is timely in that it will yield information on types of male infection and incidence of infection necessary to design vaccine efficacy studies in men. It is cost-effective, operating in Mexico with a significantly reduced cost per participant enrolled compared to the US, enrolling men representative of both countries, and partnering with industry to significantly reduce HPV genotyping costs.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA098803-04
Application #
7281209
Study Section
Epidemiology and Disease Control Subcommittee 2 (EDC)
Program Officer
Starks, Vaurice
Project Start
2004-09-27
Project End
2009-08-31
Budget Start
2007-09-01
Budget End
2008-08-31
Support Year
4
Fiscal Year
2007
Total Cost
$2,125,167
Indirect Cost
Name
H. Lee Moffitt Cancer Center & Research Institute
Department
Type
DUNS #
139301956
City
Tampa
State
FL
Country
United States
Zip Code
33612
Mainali, Bigyan; Schabath, Matthew B; Sudenga, Staci L et al. (2018) Variants in immune-related genes and genital HPV 16 persistence in men. Papillomavirus Res 7:11-14
Beachler, Daniel C; Pinto, Ligia A; Kemp, Troy J et al. (2018) An Examination of HPV16 Natural Immunity in Men Who Have Sex with Men (MSM) in the HPV in Men (HIM) Study. Cancer Epidemiol Biomarkers Prev 27:496-502
Nunes, Emily M; López, Rossana V M; Sudenga, Staci L et al. (2017) Concordance of Beta-papillomavirus across anogenital and oral anatomic sites of men: The HIM Study. Virology 510:55-59
Sudenga, Staci L; Nyitray, Alan G; Torres, B Nelson et al. (2017) Comparison of anal HPV natural history among men by country of residence: Brazil, Mexico, and the United States. J Infect 75:35-47
Rahman, Shams; Giuliano, Anna R; Rollison, Dana E et al. (2017) Cutaneous HPV and alpha-mucosal 9-valent HPV sero-status associations. Papillomavirus Res 4:54-57
Sudenga, Staci L; Torres, B Nelson; Fulp, William J et al. (2017) Country-specific HPV-related genital disease among men residing in Brazil, Mexico and The United States: The HIM study. Int J Cancer 140:337-345
Sudenga, Staci L; Torres, B Nelson; Silva, Roberto et al. (2017) Comparison of the Natural History of Genital HPV Infection among Men by Country: Brazil, Mexico, and the United States. Cancer Epidemiol Biomarkers Prev 26:1043-1052
da Silva, Roberto Jose Carvalho; Sudenga, Staci Lynn; Sichero, Laura et al. (2017) HPV-related external genital lesions among men residing in Brazil. Braz J Infect Dis 21:376-385
Hampras, Shalaka S; Rollison, Dana E; Giuliano, Anna R et al. (2017) Prevalence and Concordance of Cutaneous Beta Human Papillomavirus Infection at Mucosal and Cutaneous Sites. J Infect Dis 216:92-96
Nunes, Emily Montosa; Sudenga, Staci L; Gheit, Tarik et al. (2016) Diversity of beta-papillomavirus at anogenital and oral anatomic sites of men: The HIM Study. Virology 495:33-41

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