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

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ClinicalTrials.gov Identifier: NCT01526551
Recruitment Status : Completed
First Posted : February 6, 2012
Results First Posted : March 6, 2015
Last Update Posted : March 6, 2015
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Lake Cumberland District Health Department

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Other: HPV Vaccine and HPV-related Health Education Other: Reduction of barriers Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 935 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : August 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Schools
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
Increased education of HPV-related diseases and HPV vaccine

Other: Reduction of barriers
Eliminate structural and financial barriers to being vaccinated
Other Name: School based delivery of HPV vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program [ Time Frame: August 2012-June 2013 ]
    Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program

  2. Number of Students Who Completed HPV Vaccination as a Result of the School-based Program [ Time Frame: August 2012 -- June 2013 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01526551


Locations
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United States, Kentucky
Monticello High School
Monticello, Kentucky, United States, 42633
Wayne County High School
Monticello, Kentucky, United States, 42633
Sponsors and Collaborators
Lake Cumberland District Health Department
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Christine Weyman, M.D. Lake Cumberland District Health Department
More Information
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Responsible Party: Lake Cumberland District Health Department
ClinicalTrials.gov Identifier: NCT01526551    
Other Study ID Numbers: LCDHD-12-HPV
First Posted: February 6, 2012    Key Record Dates
Results First Posted: March 6, 2015
Last Update Posted: March 6, 2015
Last Verified: February 2015
Keywords provided by Lake Cumberland District Health Department:
Human Papillomavirus
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs