Natural History of HPV Infection in Men: The HIM Study

January 10, 2023 updated by: H. Lee Moffitt Cancer Center and Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1431

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

  1. Men ages 18-44; a pilot study group, ages 45-70;
  2. residents of 3 sites - southern Florida, US, Sao Paulo, Brazil, or state of Morelos, Mexico
  3. report no prior diagnosis of penile or anal cancers
  4. have never been diagnosed with genital and anal warts
  5. have not participated in a HPV vaccine study
  6. report no prior diagnosis with acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV)
  7. report no current penile discharge or burning during urination
  8. are not currently being treated for a sexually transmitted disease
  9. have not been imprisoned or homeless during the last 6 months
  10. have not been in drug treatment during the last 6 months
  11. no plan to relocate in the next 4 years
  12. willing to comply with 10 scheduled visits every 6 months for 4 years

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1. Men ages 18 - 44 years
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.
2. Men ages 45 - 70 years
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort Selection
Time Frame: 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).
3 years, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rates of Specific HPV Type Infection
Time Frame: 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.
4 years per participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Anna Giuliano, Ph.D., H. Lee Moffitt Cancer Center and Research Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2005

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

November 5, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (Estimate)

November 6, 2008

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-13930
  • NCI CA098803-01a1 (Other Identifier: National Cancer Institute (NCI))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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