Healthy, Immunized Communities Study

NCT ID: NCT03854734

Last Updated: 2024-07-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-14

Study Completion Date

2023-02-09

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 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.

Conditions

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Vaccine Hesitancy Communicable Diseases in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators
Following collection of baseline data, schools will be randomized. Study staff measuring the primary outcome will be blinded to school group assignment. Given the intervention, it is not possible to blind participants to group assignment.

Study Groups

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Usual Care

Educational emails about broad health topics to keep control group engaged

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type ACTIVE_COMPARATOR

Community Event

Intervention Type BEHAVIORAL

Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.

Educational Material

Intervention Type BEHAVIORAL

Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants

Interventions

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Community Event

Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.

Intervention Type BEHAVIORAL

Educational Material

Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Kraschnewski

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Kraschnewski

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

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Penn State College of Medicine

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://doi.org/10.1016/j.jvacx.2023.100273

Peer-reviewed manuscript describing primary study outcomes

Other Identifiers

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Study000011289

Identifier Type: -

Identifier Source: org_study_id

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