Human PapillomavirusNCT00786760
Natural History of HPV Infection in Men: The HIM Study
An observational study of Human Papillomavirus, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus
- What is being tested?
- Cohort: 3000 men examined every 6 months for 4 years. and Pilot study: 150 men examined every 6 months for 4 years.
- How many people
- 1,431 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2005to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute, Inc.
Tampa, Florida, 33612
About this study
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.
Read the 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
- Being tested
- Cohort: 3000 men examined every 6 months for 4 years., Pilot study: 150 men examined every 6 months for 4 years.
- Keywords
- HPV, Papillomavirus, Infection, Sexually transmitted disease, STD
- Medical subject headings
- Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 1. Men ages 18 - 44 years | Not described Receives: Other: Cohort: 3000 men examined every 6 months for 4 years. | |
| 2. Men ages 45 - 70 years | Not described Receives: Other: Pilot study: 150 men examined every 6 months for 4 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 years, 3 months
Secondary outcomes (1)
Incidence Rates of Specific HPV Type Infection
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.
Measured: 4 years per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study start14 Jun 2005
- Primary completionDec 2012
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human PapillomavirusStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,431 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anna Giuliano, Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786760
- Sponsor's protocol ID
- MCC-13930
- Other IDs
- NCI CA098803-01a1
- Status last verified
- Jan 2023
- First submitted
- 5 Nov 2008
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of HPV Infection in Men: The HIM Study
- ClinicalTrials.gov ID
- NCT00786760
- Acronym / sponsor ID
- MCC-13930
- Conditions
- Human Papillomavirus
- Keywords
- HPV, Papillomavirus, Infection, Sexually transmitted disease, STD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,431 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Jun 2005 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 1. Men ages 18 - 44 years |
| 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. | Other | 2. Men ages 45 - 70 years |
Primary outcome
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).
1 secondary outcome
Incidence Rates of Specific HPV Type Infection
Time frame: 4 years per participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Giuliano, Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort Selection (time frame: 3 years, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.