Healthy, Immunized Communities Study

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Vaccine Hesitancy; Communicable Diseases in Children
• Intervention / Treatment: Behavioral: Community Event; Behavioral: Educational Material

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 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.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Educational emails about broad health topics to keep control group engaged
Active Comparator: Multi-Component Intervention; (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; Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.; Behavioral: Educational Material; Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Jennifer Kraschnewski, Penn State College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Actual): February 28, 2020
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Vaccinations; School-based research; Vaccine hesitancy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: Study000011289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The following steps will be taken to protect subjects' privacy interests: identification and recruitment of potential subjects follows procedures consistent with privacy standards; consent discussion and research interventions will take place in a private setting; the information being collected will be limited to only the minimum amount of data necessary to accomplish the research purposes; the people with access to the identifiable research data will be limited to the minimum necessary as specified in the application and consent process. To external researchers or sponsors, data will be sent sent/received in aggregate/metrics (just counts, no individual data).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No