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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to evaluate the impact of a school-based Human Papillomavirus (HPV) vaccination program to determine if the combination of increased disease and vaccine education coupled with the removal of barriers will positively impact the HPV vaccination uptake and completion rates among students.
The purpose of this study is to evaluate the impact of a school-based HPV vaccination program. The intervention will consists of: provision of HPV vaccine information and consent forms for parents delivered in the back-to-school packets; school-nurse delivered student education; removal of barriers (scheduling, transportation and parental presence); changing of social norms; and the provision of free HPV vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Schools | Experimental | High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV Vaccine and HPV-related Health Education and Reduction of barriers to being vaccinated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV Vaccine and HPV-related Health Education | Other | Increased education of HPV-related diseases and HPV vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program | Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program | August 2012-June 2013 |
| Number of Students Who Completed HPV Vaccination as a Result of the School-based Program | Number of students who returned a parental consent form and ultimately completed the full HPV vaccination series as a result of the school-based program | August 2012 -- June 2013 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Weyman, M.D. | Lake Cumberland District Health Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monticello High School | Monticello | Kentucky | 42633 | United States | ||
| Wayne County High School |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention School | High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic HPV Vaccine and Disease Education: Increased education of disease and vaccine Reduction of barriers: eliminate barriers to being vaccinated |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Reduction of barriers | Other | Eliminate structural and financial barriers to being vaccinated |
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| Monticello |
| Kentucky |
| 42633 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention School | High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic HPV Vaccine and Disease Education: Increased education of disease and vaccine Reduction of barriers: eliminate barriers to being vaccinated |
| 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, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Grade | Number | participants |
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| Insurance Status | Number | participants |
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| Prior doses (baseline) | Number | participants |
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| 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 | Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program | Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program | Posted | Number | participants | August 2012-June 2013 |
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| Primary | Number of Students Who Completed HPV Vaccination as a Result of the School-based Program | Number of students who returned a parental consent form and ultimately completed the full HPV vaccination series as a result of the school-based program | Posted | Number | participants | August 2012 -- June 2013 |
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August 2012-June 2013
Staff developed and implemented a protocol that allowed for documentation of adverse vaccine reactions among all vaccine-receiving students.
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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 | Intervention School | High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic HPV Vaccine and Disease Education: Increased education of disease and vaccine Reduction of barriers: eliminate barriers to being vaccinated | 0 | 511 | 0 | 511 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robin Vanderpool | University of Kentucky College of Public Health | 859-218-2102 | robin@kcr.uky.edu |
| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 11th grade |
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| 12th grade |
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| missing |
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| No Insurance |
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| Underinsured |
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| Unknown |
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| 2 |
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| 3 |
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