A Study to Compare the Impact of a School Based HPV Program on Vaccination Uptake and Completion Rates

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study to Compare the Impact of a School Based HPV Vaccination Program on Vaccination Uptake and Completion Rates Among High School Students in Rural, Southeastern Kentucky

Conditions
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Human Papillomavirus

Intervention / Treatment
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* Other: HPV Vaccine and HPV-related Health Education
* Other: Reduction of barriers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have not completed three dose series of HPV vaccine Must be a student at Wayne County or Monticello High School in KY Exclusion Criteria: Completed three dose series Pregnant Contraindication to vaccine ingredients

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Schools<br>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. | Other: HPV Vaccine and HPV-related Health Education<br>* Increased education of HPV-related diseases and HPV vaccine<br>Other: Reduction of barriers<br>* Eliminate structural and financial barriers to being vaccinated<br>* Other names: School based delivery of HPV vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papillomavirus