Healthy, Immunized Communities Study

Vaccine Hesitancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03854734
• Other study ID #: Study000011289
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 14, 2019
• Est. completion date: February 28, 2023

Study information

• Verified date: December 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Communicable Diseases in Children
• Infections
• Vaccine Hesitancy

Intervention

Behavioral:
• Community Event
Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.
• Educational Material
Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants

Locations

Country	Name	City	State
United States	Penn State College of Medicine	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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