Natural History of HPV Infection in Men: The HIM Study

NCT ID: NCT00786760

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1431 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-06-14
• Study Completion Date: 2014-10-31

Brief 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.

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.

Conditions

Human Papillomavirus

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

1. Men ages 18 - 44 years

Cohort: 3000 men examined every 6 months for 4 years.

Intervention Type: OTHER

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

Pilot study: 150 men examined every 6 months for 4 years.

Intervention Type: OTHER

Prospectively assess HPV infection in a large cohort of men in the US , Mexico, and Brazil representing countries of low and high risk.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Giuliano, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Tampa, Florida, United States

Countries

United States

Other Identifiers

NCI CA098803-01a1

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-13930

Identifier Type: -

Identifier Source: org_study_id