Human Papillomavirus
Conditions
Keywords
HPV, Papillomavirus, Infection, Sexually transmitted disease, STD
Brief 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.
Interventions
OTHERCohort: 3000 men examined every 6 months for 4 years.
Prospectively assess HPV infection in a large cohort of men in the US , Mexico, and Brazil representing countries of low and high risk.
OTHERPilot study: 150 men examined every 6 months for 4 years.
Prospectively assess HPV infection in a large cohort of men in the US , Mexico, and Brazil representing countries of low and high risk.
Sponsors
National Cancer Institute (NCI)
H. Lee Moffitt Cancer Center and Research Institute
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Men between 18 and 70 years of age, living in Southern Florida, US; Sao Paulo, Brazil; or state of Morelos, Mexico. * Participant has never been told that they have penile or anal cancer or genital warts. * Willing to attend scheduled visits every 6 months in the next 4 years.
Exclusion criteria
* Prospective participants with symptoms of any STD (excluding HPV) during screening will not be eligible to participate in the study until the STD (Sexually Transmitted Disease) infection is gone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort Selection | 3 years, 3 months | The first specific aim is to establish the cohort of 3000 men ages 18 - 44 years who will be examined every 6 months for 4 years. To assess potential biases introduced by the run-in visit, Pearson's χ² test of association will be used to compare cohort participants and non-participants who attended the run-in visit with respect to known and potential HPV risk factors and HPV status. All analyses will be conducted using Intercooled STATA (StataCorp. 2001. Stata Statistical Software: Release 8.2 SE College Station, Texas: Stata Corporation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rates of Specific HPV Type Infection | 4 years per participant | The second specific aim is to determine the incidence and persistence of type-specific HPV infections. Estimates of the incidence rates of specific HPV type infection will be calculated on the basis of the number of cases in which a given type is detected for the first time in men who tested negative for that HPV type at baseline. |
Countries
United States
Outcome results
None listed