Natural History of HPV Infection in Men: The HIM Study

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Human Papillomavirus

Treatments: Other: Cohort: 3000 men examined every 6 months for 4 years.; Other: Pilot study: 150 men examined every 6 months for 4 years.

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00786760

MCC-13930

NCI CA098803-01a1 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,431 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,431 participants in 2 patient groups

1. Men ages 18 - 44 years

Treatment:

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

2. Men ages 45 - 70 years

Treatment:

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