Natural History of HPV Infection in Men: The HIM Study
Condition: Human Papillomavirus
MeSH terms: Infections; Papillomavirus Infections
Study type: Observational

Summary: 
      The purpose of this study is to learn about the natural history of Human Papillomavirus (HPV)
      infection in men. The study will also find out what factors are linked to HPV in men
      including other sexually transmitted diseases (STDs). If participants test positive for
      syphilis, gonorrhea or chlamydia, we are required by law to report the results to the Florida
      Department of Health. Participants will be able to get free medical treatment from the
      Florida Department of Health for these STDs. Participants will be given a written report of
      the results of the STD testing.
    

Detailed description: 
      The study protocol will include a pre-enrollment run-in visit, a baseline visit (enrollment),
      and 8 additional visits after enrollment scheduled 6 months apart. Intervals of every 6
      months were chosen to insure that both acquisition and loss of infections may be assessed, as
      studies in women indicate that median duration of oncogenic infections ranges between 7-9
      months. Informed consent will occur during the run-in visit. The run-in and follow-up visits
      will include questionnaire administration, visual inspection of the skin and external
      genitalia, and the collection of urine, blood, oral cells, and penile skin samples If
      anogenital lesions are present at any of the clinic visits, they will be sampled as well.
    

Intervention name(s): Cohort: 3000 men examined every 6 months for 4 years.; Pilot study: 150 men examined every 6 months for 4 years.
Intervention type(s): Other; Other
Intervention description(s): Prospectively assess HPV infection in a large cohort of men in the US , Mexico, and Brazil representing countries of low and high risk.; Prospectively assess HPV infection in a large cohort of men in the US , Mexico, and Brazil representing countries of low and high risk.
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        1. Men ages 18-44; a pilot study group, ages 45-70;

          2. residents of 3 sites - southern Florida, US, Sao Paulo, Brazil, or state of Morelos,
             Mexico

          3. report no prior diagnosis of penile or anal cancers

          4. have never been diagnosed with genital and anal warts

          5. have not participated in a HPV vaccine study

          6. report no prior diagnosis with acquired immune deficiency syndrome (AIDS) or human
             immunodeficiency virus (HIV)

          7. report no current penile discharge or burning during urination

          8. are not currently being treated for a sexually transmitted disease

          9. have not been imprisoned or homeless during the last 6 months

         10. have not been in drug treatment during the last 6 months

         11. no plan to relocate in the next 4 years

         12. willing to comply with 10 scheduled visits every 6 months for 4 years
      
Biospecimen description: 
      This study will create a specimen repository with which to test future novel hypotheses
      related to HPV infection among men. To assess other genetic, infectious, or environmental
      factors that may influence acquisition and persistence of HPV infections in men, whole blood,
      serum, exfoliated penile cell samples, and oral cells will be stored in aliquots for future
      analyses as funding becomes available. Using banked specimens preserved for DNA, RNA, and
      protein analyses, we will be able to assess novel biomarkers such as methylation status of
      oncogenic HPV, polymorphisms in genes involved in innate immunity (e.g., TLR genes), and mRNA
      of the E6 and E7 HPV oncoproteins in the future.
    
Keywords: HPV; Papillomavirus; Infection; Sexually transmitted disease; STD