NCT00786760

Natural History of HPV Infection in Men: The HIM Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,431 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2005-06-14
• Primary completion: 2012-12-01
• Completion: 2014-10-01
• First posted: 2008-11-06
• Last updated: 2023-01-11

Locations

1 site across 1 country: United States