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Clinical Trials/NCT03854734
NCT03854734
Completed
Not Applicable

A Randomized Study to Determine the Efficacy of a Multi-tiered Community- and School-based Approach to Enhance School-aged Children's Recommended Vaccinations.

Milton S. Hershey Medical Center1 site in 1 country148 target enrollmentFebruary 14, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vaccine Hesitancy
Sponsor
Milton S. Hershey Medical Center
Enrollment
148
Locations
1
Primary Endpoint
Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV)
Status
Completed
Last Updated
last year

Overview

Brief Summary

This project aims to understand how improving vaccine education and awareness can impact the number of parents who vaccinate, or intend to vaccine, their middle school-aged children with age-appropriate vaccines, including human papillomavirus (HPV), meningitis (MCV) and tetanus, diphtheria, pertussis (TDap).

Detailed Description

Vaccines are considered one of the greatest public health successes. Unfortunately, an increasing rate of parental resistance in recent years has led to a reemergence of vaccine-preventable diseases. This project seeks to determine the effect of a multi-tiered school and community-based approach to improving rates of parental intent to vaccinate for middle school-aged vaccinations including Human Papillomavirus (HPV), meningitis (MCV) and Tetanus, Diphtheria, Pertussis (TDap). By randomizing participating schools, parents receiving the intervention participated in (1) a community-based event to raise parental awareness of the importance of vaccination and (2) a social marketing campaign targeting parents' attitudes and knowledge around vaccinations. The Investigators hypothesized that participation in this study would increase parental intention to vaccinate. In addition, this study intended to improve rates of recommended vaccination among middle school-aged children, as measured through vaccine uptake information required for annual entry into Pennsylvania public schools. The Penn State team brings a breadth of experience in pediatrics, community-engaged research, adolescent health, and engagement with schools.

Registry
clinicaltrials.gov
Start Date
February 14, 2019
End Date
February 9, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Kraschnewski

Principal Investigator

Milton S. Hershey Medical Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV)

Time Frame: Participants were assessed at baseline and follow-up at 6 months.

Parental intent to vaccinate their adolescent child with Tdap, MCV, and HPV vaccines, was dichotomized for each vaccine in the survey. Tdap and MCV included the options 1) intention to vaccinate/vaccinated ("plan to get this shot before the first day of 7th grade" or "up-to-date with this shot") or 2) no intention to vaccinate ("no plans to get this shot" or "have or plan to submit an exemption for this shot"). The HPV variable excluded the option "have or plan to submit an exemption for this shot" as vaccine is not required for school entry. Variables (Tdap, MCV, HPV) were compared within and between treatment groups from baseline to 6 mo. follow up with a generalized estimating equations model using the framework of a log-binomial logistic regression model. Risk ratios resulting from these models were used to quantify the magnitude and direction of any significant differences.

Study Sites (1)

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