Natural History of HPV Infection in Men: The Health in Men Study
Anna R.Giuliano, Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida
Funded since 2004
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 in the United States and Europe. In the United States, 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. Little is known about
the prevalence, incidence, and clearance of HPV infections in men, however,
hampering efforts to control infection in both men and women.
The investigators are conducting a large, bi-national (U.S.-Mexico) prospective
study of men in order to further our understanding of the natural history
of HPV infection among them, so that effective programs can be developed
to reduce its burden in both men and women. The aims are to:
- enroll a cohort of 3,000 men who will be examined every six months
for four years,
- determine the incidence and persistence of type-specific penile HPV
infections,
- determine 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.
The investigators hypothesize that distribution of type of HPV infection
in men differs by country, most infections in men are transient, and that
type-specific HPV antibody response occurs only among persistently HPV-positive
men. They also hypothesize that current condom use and circumcision confer
reduced risk of incident HPV infection and that other sexually acquired
infections increase risk.
The study is unique because it will prospectively assess HPV infection
in a large cohort of men in the United States and Mexico, representing
countries of high and low risk. It also is timely because it will yield
information on types of male infection and incidence of infection necessary
to design vaccine efficacy studies in men. Further, the study is cost-effective,
operating in Mexico with a significantly reduced cost-per-participant
enrolled compared to the United States, enrolling men representative of
both countries, and partnering with industry to significantly reduce HPV
genotyping costs.
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