Anus NeoplasmsNCT00799474
Men's Beliefs About Associations Between HPV, Cancers, and HPV Vaccination
An observational study of Anus Neoplasms, run by University of North Carolina, Chapel Hill.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anus Neoplasms
- How many people
- 609 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Jan 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 59 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Approximately 600 men (ages 18-59) who have agreed to participate in a periodic panel through the private survey company, Knowledge Networks.
Who may be able to join
- male
- aged 18-59
- answered question about sexual orientation
Who cannot join
- none
About this study
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.
Read the 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.
- Conditions
- Anus Neoplasms
- Medical subject headings
- Anus Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to Receive the Human Papillomavirus (HPV) Vaccine
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.
Measured: at time of interview
Secondary outcomes (2)
Awareness of HPV Vaccine
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".
Measured: At time of interview
Knowledge of HPV
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.
Measured: At time of interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anus NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Noel Brewer, PhD, Principal investigator, The University of North Carolina at Chapel Hill, School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799474
- Sponsor's protocol ID
- Merck-558377
- Status last verified
- Jan 2010
- First submitted
- 26 Nov 2008
- Last updated
- 24 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Men's Beliefs About Associations Between HPV, Cancers, and HPV Vaccination
- ClinicalTrials.gov ID
- NCT00799474
- Acronym / sponsor ID
- Merck-558377
- Conditions
- Anus Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Dec 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 27 Nov 2008 (estimated)
- Results
- Posted 15 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Approximately 600 men (ages 18-59) who have agreed to participate in a periodic panel through the private survey company, Knowledge Networks.
Key inclusion criteria (3 listed)
- male
- aged 18-59
- answered question about sexual orientation
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Awareness of HPV Vaccine
Time frame: At time of interview
Knowledge of HPV
Time frame: At time of interview
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Noel Brewer, PhD principal investigator
The University of North Carolina at Chapel Hill, School of Public Health
Questions about this trial
What is this clinical trial studying?
An observational study of Anus Neoplasms, run by University of North Carolina, Chapel Hill.
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 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 15 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Willingness to Receive the Human Papillomavirus (HPV) Vaccine (time frame: at time of interview). 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 24 Mar 2016.