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

Not Applicable

Completed

• Conditions: Human Papillomavirus
• Interventions: Other: HPV Vaccine and HPV-related Health Education; Other: Reduction of barriers

• Registration Number: NCT01526551
• Lead Sponsor: Lake Cumberland District Health Department

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2012-02-03
• Study First Posted: 2012-02-06
• Study Start: 2012-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-02
• Results First Submitted: 2015-02-19
• Results First Submitted QC: 2015-02-19
• Last Update Submitted: 2015-02-19
• Results First Posted: 2015-03-06
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 935

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Schools	Reduction of barriers	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.
Intervention Schools	HPV Vaccine and HPV-related Health Education	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.

Primary Outcome Measures

Name	Time	Method
Number of Students Who Completed HPV Vaccination as a Result of the School-based Program	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
Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program	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

Trial Locations

Locations (2)

Monticello High School; 🇺🇸 Monticello, Kentucky, United States

Wayne County High School; 🇺🇸 Monticello, Kentucky, United States