School Located Adolescent Vaccination Study

Not Applicable

Completed

• Conditions: School Located Vaccine Program
• Interventions: Behavioral: School Located Vaccine (SLV) Program

• Registration Number: NCT01719679
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The provision of adolescent vaccination in a school setting will be feasible and acceptable to parents as evidenced by the number and percentage of students immunized within each school compared to those in schools without a program. The likelihood of vaccination for diphtheria, tetanus, and pertussis (Tdap), human papillomavirus (HPV), and meningococcal conjugate vaccine (MCV4) and all three combined) among eligible students enrolled in schools with a comprehensive school-based immunization program will be significantly higher than that of students enrolled in schools without a school-based immunization program.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2011-08
• Study Completion: 2011-10
• Status Verified: 2012-09
• Study First Submitted: 2012-10-30
• Study First Submitted QC: 2012-10-30
• Study First Posted: 2012-11-01
• Last Update Submitted: 2012-12-31
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• 2000 (1000 at intervention schools and 1000 in control schools) randomly selected students enrolled in 6th - 8th grade at randomly selected schools
• students who appear to be in need of one or more immunizations of interest at the beginning of the school year
• students enrolled in school by October 1st registration deadline will be included in the analysis

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Exclusion Criteria

• students who appear to have had all immunizations of interest at the beginning of the school year
• students enrolled after the October 1 school registration deadline will be excluded from the analysis
• students enrolled in grades other than 6th, 7th, or 8th grade will not be eligible to participate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
School Located Vaccine (SLV) Program	School Located Vaccine (SLV) Program	A vaccine program carried out by a community vaccinator will be conducted in a limited number of participating schools. The program will be open to the students enrolled at the participating schools

Primary Outcome Measures

Name	Time	Method
The likelihood of vaccination among eligible 6th grade students with one or more needed vaccines in intervention schools compared to control schools.	end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011	The vaccination status of eligible students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
The likelihood of vaccination among eligible 6th grade students with Tdap vaccine in intervention schools compared to control schools.	end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011	The Tdap vaccination status of eligible students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
The likelihood of vaccination among eligible 6th grade students with MCV4 vaccine in intervention schools compared to control schools.	end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011	The MCV4 vaccination status of eligible students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
The likelihood of vaccination among eligible 6th grade female students with HPV vaccine in intervention schools compared to control schools.	end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011	The HPV vaccination status of eligible female students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.

Secondary Outcome Measures

Name	Time	Method
The likelihood of vaccination with Tdap vaccine among eligible 7th and 8th grade students enrolled at intervention schools compared to control schools.	end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011	The Tdap vaccination status of students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
The likelihood of vaccination with one or more HPV vaccines among eligible 7th and 8th grade female students enrolled in intervention schools compared to control schools.	end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011	The HPV vaccination status of eligible female students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
The likelihood of MCV4 vaccination among eligible 7th and 8th students enrolled in intervention schools compared to control schools.	end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011	The MCV4 vaccination status of eligible 7th and 8th grade students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
The likelihood of HPV vaccine series completion among female students in intervention schools compared to control schools.	end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011	The HPV vaccine status of female students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.

Trial Locations

Locations (2)

Kaiser Permanente Colorado; 🇺🇸 Denver, Colorado, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States