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

Human Papillomavirus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526551
• Other study ID #: LCDHD-12-HPV
• Status: Completed
• Phase: N/A
• First received: December 22, 2011
• Last updated: February 19, 2015
• Start date: August 2012
• Est. completion date: August 2013

Study information

• Verified date: February 2015
• Source: Lake Cumberland District Health Department
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 935
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 20 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

Other:
• HPV Vaccine and HPV-related Health Education
Increased education of HPV-related diseases and HPV vaccine
• Reduction of barriers
Eliminate structural and financial barriers to being vaccinated

Locations

Country	Name	City	State
United States	Monticello High School	Monticello	Kentucky
United States	Wayne County High School	Monticello	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Lake Cumberland District Health Department	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program	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	No
Primary	Number of Students Who Completed HPV Vaccination as a Result of the School-based Program	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	No