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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Lake Cumberland District Health Department
ClinicalTrials.gov Identifier:
NCT01526551
First received: December 22, 2011
Last updated: February 19, 2015
Last verified: February 2015
  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
Human Papillomavirus
Other: HPV Vaccine and HPV-related Health Education
Other: Reduction of barriers

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

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

Primary Outcome Measures:
  • Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program [ Time Frame: August 2012-June 2013 ] [ Designated as safety issue: No ]
    Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program

  • Number of Students Who Completed HPV Vaccination as a Result of the School-based Program [ Time Frame: August 2012 -- June 2013 ] [ Designated as safety issue: No ]
    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


Enrollment: 935
Study Start Date: August 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526551

Locations
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
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
Results First Received: February 19, 2015
Last Updated: February 19, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Lake Cumberland District Health Department:
Human Papillomavirus

ClinicalTrials.gov processed this record on March 25, 2015