A Study to Compare the Impact of a School Based HPV Program on Vaccination Uptake and Completion Rates
1 other identifier
interventional
935
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2011
CompletedFirst Posted
Study publicly available on registry
February 6, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
March 6, 2015
CompletedMarch 6, 2015
February 1, 2015
1 year
December 22, 2011
February 19, 2015
February 19, 2015
Conditions
Keywords
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
EXPERIMENTALHigh 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.
Interventions
Increased education of HPV-related diseases and HPV vaccine
Eliminate structural and financial barriers to being vaccinated
Eligibility Criteria
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
Wayne County High School
Monticello, Kentucky, 42633, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Robin Vanderpool
- Organization
- University of Kentucky College of Public Health
Study Officials
- PRINCIPAL INVESTIGATOR
Christine Weyman, M.D.
Lake Cumberland District Health Department
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