Natural History of HPV Infection in Men: The HIM Study

NCT00786760 | Completed

• 2 other identifiers: MCC-13930NCI CA098803-01a1
• Study Type: observational
• Target: 1,431
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus

Keywords

HPV; Papillomavirus; Infection; Sexually transmitted disease; STD

Outcome Measures

Primary Outcomes (1)

• 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 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 Outcomes (1)

• Incidence Rates of Specific HPV Type Infection

  4 years per participant

Study Arms (2)

1. Men ages 18 - 44 years

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

2. Men ages 45 - 70 years

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

Interventions

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

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

1. Men ages 18 - 44 years

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Tampa, Florida, 33612, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

This study will create a specimen repository with which to test future novel hypotheses related to HPV infection among men. To assess other genetic, infectious, or environmental factors that may influence acquisition and persistence of HPV infections in men, whole blood, serum, exfoliated penile cell samples, and oral cells will be stored in aliquots for future analyses as funding becomes available. Using banked specimens preserved for DNA, RNA, and protein analyses, we will be able to assess novel biomarkers such as methylation status of oncogenic HPV, polymorphisms in genes involved in innate immunity (e.g., TLR genes), and mRNA of the E6 and E7 HPV oncoproteins in the future.

MeSH Terms

Conditions

Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna Giuliano, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 6, 2008
• Study Start: June 14, 2005
• Primary Completion: December 1, 2012
• Study Completion: October 1, 2014
• Last Updated: January 11, 2023

Record last verified: 2023-01

Locations

US (1)