Healthy, Immunized Communities Study

NCT03854734 | Completed Results

• 1 other identifier: Study000011289
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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).

Conditions

Vaccine Hesitancy; Communicable Diseases in Children

Keywords

Vaccinations; Vaccine hesitancy; School-based research

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Usual Care

NO INTERVENTION

Educational emails about broad health topics to keep control group engaged

Multi-Component Intervention

ACTIVE COMPARATOR

(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; Behavioral: Educational Material

Interventions

Community Event BEHAVIORAL

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

Multi-Component Intervention

Educational Material BEHAVIORAL

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

Multi-Component Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Related Links

• Peer-reviewed manuscript describing primary study outcomes

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

We experienced low parent participation in the intervention activities, potentially limiting the effectiveness of the intervention and resulting outcomes.

Results Point of Contact

• Title: Dr. Jennifer Kraschnewski, Professor of Medicine and Public Health Sciences
• Organization: Penn State College of Medicine

jkraschnewski@pennstatehealth.psu.edu

717-531-8161

Study Officials

• Jennifer Kraschnewski

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 26, 2019
• Study Start: February 14, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 9, 2023
• Last Updated: July 12, 2024
• Results First Posted: July 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)