Clinical trial NCT03854734: Healthy, Immunized Communities Study
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine Hesitancy
Communicable Diseases in Children
Keywords: Vaccinations
Vaccine hesitancy
School-based research
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-02-26
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV)
timeFrame: Participants were assessed at baseline and follow-up at 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Jennifer Kraschnewski
role: PRINCIPAL_INVESTIGATOR
References: