NCT01526551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
935

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 6, 2015

Completed
Last Updated

March 6, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

December 22, 2011

Results QC Date

February 19, 2015

Last Update Submit

February 19, 2015

Conditions

Keywords

Human Papillomavirus

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Intervention Schools

EXPERIMENTAL

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 EducationOther: Reduction of barriers

Interventions

Increased education of HPV-related diseases and HPV vaccine

Intervention Schools

Eliminate structural and financial barriers to being vaccinated

Also known as: School based delivery of HPV vaccine
Intervention Schools

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Must have not completed three dose series of HPV vaccine
  • Must be a student at Wayne County or Monticello High School in KY

You may not qualify if:

  • Completed three dose series
  • Pregnant
  • Contraindication to vaccine ingredients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Monticello High School

Monticello, Kentucky, 42633, United States

Location

Wayne County High School

Monticello, Kentucky, 42633, United States

Location

MeSH Terms

Interventions

Papillomavirus Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Dr. Robin Vanderpool
Organization
University of Kentucky College of Public Health

Study Officials

  • Christine Weyman, M.D.

    Lake Cumberland District Health Department

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2011

First Posted

February 6, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

March 6, 2015

Results First Posted

March 6, 2015

Record last verified: 2015-02

Locations