Natural History of HPV Infection in Men: The HIM Study
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
Observational Model: Ecologic or Community, Time Perspective: Prospective
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).
3 years, 3 months
Anna Giuliano, Ph.D.
H. Lee Moffitt Cancer Center and Research Institute, Inc.
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center and Research Institute, Inc.||Tampa, Florida 33612|