- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00799474
Men's Beliefs About Associations Between HPV, Cancers, and HPV Vaccination
February 25, 2016 updated by: University of North Carolina, Chapel Hill
This research focuses on men who have sex with men (MSM) who are at higher risk of anal cancer.
The survey will evaluate their beliefs about anal and oral cancer, their knowledge about role of human papillomavirus (HPV) infection in these cancers, and their knowledge of HPV vaccination and anal Pap smears.
Approximately 12% of subjects will be HIV-positive.
Study Overview
Status
Completed
Conditions
Detailed Description
Little research has examined men's understanding of what causes anal and oral cancers and whether HPV vaccination can play a potential protective role.
This research focuses on men who have sex with men (MSM) who are at notably elevated risk of anal cancer, and seeks to characterize their beliefs about anal and oral cancer, knowledge about the etiological role of HPV infection in these cancers, as well as their knowledge of HPV vaccination and anal Pap smears.
We will also study heterosexual men.
Study Type
Observational
Enrollment (Actual)
609
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
Approximately 600 men (ages 18-59) who have agreed to participate in a periodic panel through the private survey company, Knowledge Networks.
Description
Inclusion Criteria:
- male
- aged 18-59
- answered question about sexual orientation
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Willingness to Receive the Human Papillomavirus (HPV) Vaccine
Time Frame: at time of interview
|
Measured participants' willingness to receive HPV vaccine.
Participants were asked how willing they would be to get HPV vaccine if it were approved for use in males.
A 5-point scale ranging from "definitely not willing" to "definitely willing" was used to meausure willingness.
|
at time of interview
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Awareness of HPV Vaccine
Time Frame: At time of interview
|
Measured if participants had heard of HPV vaccine prior to survey.
Participants were asked if they had heard to HPV vaccine prior to the survey and had response options of "yes", "no", and "I don't know".
|
At time of interview
|
|
Knowledge of HPV
Time Frame: At time of interview
|
Assessed participants' knowledge of HPV by summing correct responses to nine HPV knowledge items.
Questions addressed what diseases are associated with HPV, how HPV is transmitted, and how common HPV infection is.
For each item, participants were classified as having answered the item correctly or incorrectly.
|
At time of interview
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Noel Brewer, PhD, The University of North Carolina at Chapel Hill, School of Public Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
November 26, 2008
First Submitted That Met QC Criteria
November 26, 2008
First Posted (Estimate)
November 27, 2008
Study Record Updates
Last Update Posted (Estimate)
March 24, 2016
Last Update Submitted That Met QC Criteria
February 25, 2016
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Merck-558377
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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