Natural History of HPV Infection in Men: The HIM Study

Human Papillomavirus Clinical Trial

Official title:

Natural History of HPV Infection in Men: The HIM Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786760
• Other study ID #: MCC-13930
• Secondary ID: NCI CA098803-01a
• Status: Completed
• Start date: June 14, 2005
• Est. completion date: October 2014

Study information

• Verified date: January 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1431
• Est. completion date: October 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Human Papillomavirus
• Infections
• Papillomavirus Infections

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute, Inc.	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort Selection	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 ?² 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
Secondary	Incidence Rates of Specific HPV Type Infection	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.	4 years per participant

External Links

•   Moffitt Cancer Center Clinical Trials website