Overview

This trial is active, not recruiting.

Condition human papillomavirus
Treatments cohort: 3000 men examined every 6 months for 4 years., pilot study: 150 men examined every 6 months for 4 years.
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborator National Cancer Institute (NCI)
Start date June 2005
End date February 2016
Trial size 1431 participants
Trial identifier NCT00786760, MCC-13930, NCI CA098803-01a1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective prospective
Arm
cohort: 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.
pilot 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.

Primary Outcomes

Measure
Cohort Selection
time frame: 3 years, 3 months

Secondary Outcomes

Measure
Incidence Rates of Specific HPV Type Infection
time frame: 4 years per participant

Eligibility Criteria

Male participants from 18 years up to 70 years old.

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.

Additional Information

Official title Natural History of HPV Infection in Men: The HIM Study
Principal investigator Anna Giuliano, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.