Healthy, Immunized Communities Study

Study Overview
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Brief Summary
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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
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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 will participate in (1) a community-based event to raise parental awareness of the importance of vaccination and (2) a social marketing to target parents' attitudes and knowledge around vaccinations. The Investigators hypothesize that participation in this study will increase parental intention to vaccinate. In addition, this study intends 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.

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

Conditions
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Vaccine Hesitancy, Communicable Diseases in Children

Intervention / Treatment
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* Behavioral: Community Event
* Behavioral: Educational Material


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 18 years or older Parents and guardians of children who attend a School District of Lancaster middle schools Individuals who read and understand English Individuals with an email address Exclusion Criteria Individuals who are non-English speaking Parents/Guardians <18 years or older who do not have children attending a middle school in the School District of Lancaster Individuals who do not have an email address Individuals who plan on moving out of the Lancaster City area in the next year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Educational emails about broad health topics to keep control group engaged | |
| Active Comparator: Multi-Component Intervention<br>(1) a community event to raise parental awareness of the importance of vaccination; (2) social marketing to target parents' attitudes and knowledge around vaccinations in the form of educational material | Behavioral: Community Event<br>* Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.<br>Behavioral: Educational Material<br>* Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intention by parents to vaccinate school-aged children, as measured by survey | The change between the pre- and post-intervention proportions will be compared within the study groups as well as between the two groups using a generalized estimating equations (GEE) model that includes factors for time, study group, and the interaction between the time and study group. Given that there is no specific power calculation for a GEE model, this study will focus on a subcomponent of this analysis for the comparison of the change within the intervention group between pre and post and double the sample size to account for the control group. The comparison of the change between the pre- and post-intervention proportions could be accomplished with a McNemar's test. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of recommended vaccination among school-aged children | Evaluate pre and post-intervention rates for the intervention vs. control schools schools as provided in aggregate level by the school district | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccinations, Vaccine hesitancy, School-based research