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

February 19, 2015 updated by: Lake Cumberland District Health Department

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

935

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Monticello, Kentucky, United States, 42633
        • Monticello High School
      • Monticello, Kentucky, United States, 42633
        • Wayne County High School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • School based delivery of HPV vaccine

What is the study measuring?

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
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
August 2012-June 2013
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
August 2012 -- June 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lake Cumberland District Health Department

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Christine Weyman, M.D., Lake Cumberland District Health Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

December 22, 2011

First Submitted That Met QC Criteria

February 3, 2012

First Posted (ESTIMATE)

February 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2015

Last Update Submitted That Met QC Criteria

February 19, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCDHD-12-HPV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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