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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | at time of interview |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | At time of interview |
| Knowledge of HPV |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 600 men (ages 18-59) who have agreed to participate in a periodic panel through the private survey company, Knowledge Networks.
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| Name | Affiliation | Role |
|---|---|---|
| Noel Brewer, PhD | The University of North Carolina at Chapel Hill, School of Public Health | Principal Investigator |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Participants | All study participants, this observational study was not a trial that involved multiple arms |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Participants | All study participants, this observational study was not a trial that involved multiple arms |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | One man reported having received human papillomavirus (HPV) vaccine so he was not asked willingness items which made the analytic sample size n=608 | Posted | Number | Participants | at time of interview |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Participants | All study participants, this observational study was not a trial that involved multiple arms |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Noel Brewer, PhD | The University of North Carolina at Chapel Hill, Gillings School of Global Public Health | 919-966-3282 | ntb1@unc.edu |
| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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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 |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
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| Counts |
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| Participants |
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| 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". | Posted | Number | Participants | At time of interview |
|
|
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| 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. | HPV knowledge items were only asked to those men who had heard of HPV prior to survey (n=430) | Posted | Mean | Standard Deviation | Correct Responses | At time of interview |
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| 0 |
| 609 |
| 0 |
| 609 |
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| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |