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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01526551
First Posted: February 6, 2012
Last Update Posted: March 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Lake Cumberland District Health Department
  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: 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

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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
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

Responsible Party: Lake Cumberland District Health Department
ClinicalTrials.gov Identifier: NCT01526551     History of Changes
Other Study ID Numbers: LCDHD-12-HPV
First Submitted: December 22, 2011
First Posted: February 6, 2012
Results First Submitted: February 19, 2015
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:
Vaccines
Immunologic Factors
Physiological Effects of Drugs