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.