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Natural History of HPV Infection in Men: The HIM Study


N/A
18 Years
70 Years
Open (Enrolling)
Male
Human Papillomavirus

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Trial Information

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
as well.


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.

Type of Study:

Observational

Study Design:

Observational Model: Ecologic or Community, Time Perspective: Prospective

Outcome Measure:

Cohort Selection

Outcome Description:

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).

Outcome Time Frame:

3 years, 3 months

Safety Issue:

No

Principal Investigator

Anna Giuliano, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute, Inc.

Authority:

United States: Institutional Review Board

Study ID:

MCC-13930

NCT ID:

NCT00786760

Start Date:

June 2005

Completion Date:

July 2014

Related Keywords:

  • Human Papillomavirus
  • HPV
  • Papillomavirus
  • Infection
  • Sexually transmitted disease
  • STD

Name

Location
H. Lee Moffitt Cancer Center and Research Institute, Inc. Tampa, Florida  33612