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

This study is not yet open for participant recruitment.
Verified February 2012 by Lake Cumberland District Health Department
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Lake Cumberland District Health Department
ClinicalTrials.gov Identifier:
NCT01526551
First received: December 22, 2011
Last updated: February 3, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Human Papillomavirus
 Other: HPV Vaccine and Disease Education
Other: Reduction of barriers
Other: Survey
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
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

Further study details as provided by Lake Cumberland District Health Department:

Primary Outcome Measures:
  • Change in number of participants, by gender, who receive HPV vaccination [ Time Frame: Baseline and One Year ] [ Designated as safety issue: No ]
    Number of participants who have received HPV vaccination prior to start of study


Secondary Outcome Measures:
  • Change in number of participants, by gender, who complete the HPV vaccination series [ Time Frame: Baseline and One Year ] [ Designated as safety issue: No ]
    Number of participants who have complete the HPV vaccination series prior to start of study


Estimated Enrollment: 891
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention School
High school students attending Wayne County and Monticello Ind. schools
 Other: HPV Vaccine and Disease Education
Increased education of disease and vaccine
Other Names:
  • HPV Vaccine Information Sheet
  • HPV Disease Education Sheet
  • HPV Disease Education Video
Other: Reduction of barriers
eliminate barriers to being vaccinated
Other Name: School based delivery of HPV vaccine.
No Intervention: No intervention
observational; no intervention.
 Other: Survey
No intervention- survey only
Other Names:
  • No intervention given.
  • Patient survey regarding HPV vaccine status only.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526551

Contacts
Contact: Christine Weyman, M.D. 606-678-4761 ext 1110 christine.weyman@lcdhd.org
Contact: Carol Huckelby 606-678-4761 ext 1140 carola.huckelby@lcdhd.org

Locations
United States, Kentucky
Wayne County High School Not yet recruiting
Monticello, Kentucky, United States, 42633
Contact: Amy D Edwards, RN     606-348-5575     amyd.edwards@lcdhd.org    
Principal Investigator: Christine Weyman, MD            
Monticello High School Not yet recruiting
Monticello, Kentucky, United States, 42633
Contact: Kristi D Upchurch, RN     606-348-1814     kristid.upchurch@lcdhd.org    
Principal Investigator: Christine Weyman, MD            
Sponsors and Collaborators
Lake Cumberland District Health Department
Merck
Investigators
Principal Investigator: Christine Weyman, M.D. Lake Cumberland District Health Department
  More Information

No publications provided

Responsible Party: Lake Cumberland District Health Department
ClinicalTrials.gov Identifier: NCT01526551     History of Changes
Other Study ID Numbers: LCDHD-12-HPV
Study First Received: December 22, 2011
Last Updated: February 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Lake Cumberland District Health Department:
Human Papillomavirus

ClinicalTrials.gov processed this record on May 22, 2013