Anus Neoplasms
Conditions
Brief 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. 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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
University of North Carolina, Chapel Hill
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* male * aged 18-59 * answered question about sexual orientation
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Willingness to Receive the Human Papillomavirus (HPV) Vaccine | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Awareness of HPV Vaccine | 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. |
| Knowledge of HPV | 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. |
Participant flow
Recruitment details
Data was collected for this cross-sectional study through an online survey. Of the 874 men invited to participate, 609 (70%) completed the online survey. A pilot test was conducted between December 29, 2008 and January 4, 2009, and the main survey was conducted between January 6, 2009 and January 26, 2009.
Participants by arm
| Arm | Count |
|---|---|
| Study Participants All study participants, this observational study was not a trial that involved multiple arms | 609 |
| Total | 609 |
Baseline characteristics
| Characteristic | Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 609 Participants |
| Age, Continuous | 44.5 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment United States | 609 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 609 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 609 |
| serious Total, serious adverse events | 0 / 609 |
Outcome results
Primary
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.
Time frame: at time of interview
Population: One man reported having received human papillomavirus (HPV) vaccine so he was not asked willingness items which made the analytic sample size n=608
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Participants | Willingness to Receive the Human Papillomavirus (HPV) Vaccine | 338 Participants |
Secondary
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.
Time frame: At time of interview
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Participants | Awareness of HPV Vaccine | 415 Participants |
Secondary
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.
Time frame: At time of interview
Population: HPV knowledge items were only asked to those men who had heard of HPV prior to survey (n=430)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Participants | Knowledge of HPV | 4.01 Correct Responses | Standard Deviation 2.42 |