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Completed

NCT Number: NCT04568590

Promoting Altruism to Enhance Vaccine Acceptance

Subjects enrolled in this study are eligible for the seasonal influenza vaccine. The purpose of this research study is to figure out if increasing individuals' awareness of the benefits of herd immunity, specifically to the local pediatric oncology community, can improve vaccination uptake rates.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Univesity Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

The purpose of this study is to identify associations with influenza vaccine hesitancy, including parental demographics and altruism score, in families with healthy children attending two pediatric practices.

Also, in the cohort of families with baseline vaccine hesitancy, to assess the effectiveness of a pilot educational intervention focusing on the development of herd immunity for pediatric oncology patients by measuring:

  • The change in vaccine hesitancy scores pre- and post-intervention.
  • The rate of influenza vaccine uptake compared to historic controls from previous influenza seasons.

Another aim is to explore the relationship between baseline influenza vaccine hesitancy rates and baseline altruism scores. Effectiveness of this intervention is dependent on parental altruism levels; therefore, the study team also seeks to determine if there is an association between parental altruism and vaccine hesitancy for their children.

This is a single-arm prospective cohort study. The study will enroll legal guardians of children who are influenza vaccine-eligible to measure their vaccine hesitancy scores, altruism scores, and the impact of an educational intervention focused on herd immunity on the guardians' vaccine hesitancy score.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All legal guardians of children aged 6 months and up who are influenza vaccine-eligible and present to the pediatric clinic.

Exclusion criteria

  • Legal guardians of children who are not influenza vaccine-eligible including children less than 6 months of age, children on immunosuppressive medications, and children with underlying medical conditions resulting in an immunocompromised state.

Treatment and study plan

Educational intervention

Behavioral

If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average > 3), they will be given the informational handout along with a brief script.

Primary outcomes

  1. Change in Vaccine Hesitancy Scores Pre- and Post-Intervention.

    Time frame: Baseline (Pre-intervention) and Post-Intervention, up to 4 hours

    8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score >/= 3. Score range is 1-5 and > or = 3 is considered vaccine hesitant.

  2. Pre-Intervention Vaccine Hesitancy Score

    Time frame: baseline

    8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score >/= 3. Score range is 1-5 and > or = 3 is considered vaccine hesitant.

  3. Post-Intervention Vaccine Hesitancy Score

    Time frame: Post-Intervention up to 4 Hours

    8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score >/= 3. Score range is 1-5 and > or = 3 is considered vaccine hesitant.

Secondary outcomes

  1. Rate of Influenza Vaccine Uptake

    Time frame: baseline

    The subject's child's electronic health record will be accessed to document whether that patient received the seasonal influenza vaccine during the baseline visit.

  2. Pre-Intervention Altruism Scale

    Time frame: baseline

    Scale ranges from 20-100 with a higher score denoting higher altruism.

Other outcomes

  1. Complex Interaction Interviews

    Time frame: Month 9

    Motivational interviews will be conducted with 20 vaccine-hesitant participants, and with four study volunteers. Each motivational interview will be conducted by the same person. Data from these interviews will be entered directly into a Research Electronic Data Capture database and analyzed using Statistical Analysis Software (SAS v9.4).

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Cohort Study to Determine the Effect of an Educational Intervention Focusing on Herd Immunity to Enhance Vaccination Uptake Rates

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 29, 2020
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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