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: Completed
• 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 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.

• 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: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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
Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV)	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.	Participants were assessed at baseline and follow-up at 6 months.

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

Publications and helpful links

Helpful Links

• Peer-reviewed manuscript describing primary study outcomes

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 9, 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 (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

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