The study population consisted of men who met the following eligibility criteria: (a) ages 18 to 70 years; (b) residents of one of three sites—São Paulo, Brazil; the state of Morelos, Mexico; or southern Florida, United States; (c) reported no prior diagnosis of penile or anal cancers; (d) have never been diagnosed with genital or anal warts; (e) currently report no symptoms of a sexually transmitted infection or treatment for a sexually transmitted infection; (f) not participating in an HPV vaccine study; (g) no history of HIV or AIDS; (h) no history of imprisonment, homelessness, or drug treatment during the past 6 months; and (i) willing to comply with 10 scheduled visits every 6 months for 4 years with no plans to relocate within the next 4 years.
Men were recruited from three different population sources—the general population, universities, and organized health care systems (Mexico only)—to increase access to men with a broad range of ages, sexual behaviors, and HPV risk. In Brazil, men were recruited from the general population at a facility for urogenital care (Centro de Referencia e Tratamento de Doencas Sexualmente Transmissiveis e AIDS) and through general media advertising. Men presenting for non–sexually transmitted infection–related conditions were enrolled in the present study. In addition, the spouses and partners of women participating in a large cohort study of the natural history of HPV infection and risk of cervical neoplasia conducted in São Paulo since 1993 were also recruited.
At the Cuernavaca, Mexico site, the underlying population was comprised of employees and beneficiaries of the Instituto Mexicano de Seguro Social, factory employees, and officials of the Mexican army that are permanently assigned to this geographic area. In the United States, the underlying population was from the University of South Florida and the greater Tampa metropolitan area. Flyers and posters were distributed throughout the campus and community, and we administered monthly educational presentations. In addition, men from the broader Tampa Bay, FL community were recruited through the mail and media using brochures and flyers as well as advertisements in local and university papers.