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Completed

NCT Number: NCT01526551

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

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.

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Key information

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monticello High School, Monticello, Kentucky, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPV Vaccine and HPV-related Health Education

Other

Increased education of HPV-related diseases and HPV vaccine

Reduction of barriers

Other

Eliminate structural and financial barriers to being vaccinated

Other names: School based delivery of HPV vaccine

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Lake Cumberland District Health Department

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 6, 2012
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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