Natural History of HPV Infection in Men: The HIM Study

• ClinicalTrials.gov Identifier: NCT00786760
• Recruitment Status: Active, not recruiting
• First Posted: November 6, 2008
• Last Update Posted: August 5, 2019
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): H. Lee Moffitt Cancer Center and Research Institute

Tracking Information

• First Submitted Date: November 5, 2008
• First Posted Date: November 6, 2008
• Last Update Posted Date: August 5, 2019
• Actual Study Start Date: June 14, 2005
• Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 11, 2011)

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).

• Original Primary Outcome Measures (submitted: November 5, 2008): Determine the incidence and persistence of type-specific penile HPV infections 37 HPV types that commonly infect the genital tract among men residing in the US , Mexico, and Brazil. Study the humoral immune response to HPV infection. [ Time Frame: 4 years per participant ]
• Change History: Complete list of historical versions of study NCT00786760 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: October 11, 2011)

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.

• Original Secondary Outcome Measures (submitted: November 5, 2008): Identify factors (e.g., sexual behavior, condom use, circumcision, concurrent sexually transmitted infections) independently associated with acquisition, persistence, and clearance of type-specific HPV infections in men. [ Time Frame: 4 years per participant ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Natural History of HPV Infection in Men: The HIM Study
• Official Title: Natural History of HPV Infection in Men: The HIM Study
• 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.
• Study Type: Observational
• Study Design: Observational Model: Ecologic or Community; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

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.

• 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

• Condition: Human Papillomavirus

Intervention

• 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.

Study Groups/Cohorts

• 1. Men ages 18 - 44 years
  Intervention: Other: Cohort: 3000 men examined every 6 months for 4 years.
• 2. Men ages 45 - 70 years
  Intervention: Other: Pilot study: 150 men examined every 6 months for 4 years.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 8, 2012): 1431
• Original Estimated Enrollment (submitted: November 5, 2008): 1000
• Estimated Study Completion Date: May 2020
• Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00786760
• Other Study ID Numbers: MCC-13930; NCI CA098803-01a1 ( Other Identifier: National Cancer Institute (NCI) )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• 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.

• PRS Account: H. Lee Moffitt Cancer Center and Research Institute
• Verification Date: August 2019