Peer Education as a Strategy to Promote Vaccine Acceptance

Developing Vaccine Educators Within Practices of Community Healthcare Providers: a Pragmatic, Randomized Controlled Trial of Peer Education to Promote Vaccine Acceptance

Effective interventions to improve uptake of vaccines among hesitant groups are urgently needed. Peer education is an effective intervention in modifying health behaviors in other conditions and may be effective in promoting vaccine confidence but has not been studied. To fill this knowledge gap, we will enroll approximately 152 parents of children age 0-18 months who are eligible for pneumococcal conjugate (PCV-13) vaccine and randomize them 1:1 to a peer-led vaccine education intervention or usual care.

Study Overview

• Status: Completed
• Conditions: Vaccine Acceptance
• Intervention / Treatment: Behavioral: Peer-led vaccine education intervention

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Grossman School of Medicine, Division of Infectious Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. A parent of a child aged 0 to 18 months born at ≥35 weeks' gestation who is eligible for a dose of PCV-13. Eligibility by age defined as follows:

   1. Age 0-6 months: never received first dose or is >8 weeks from last dose (3 doses scheduled in this age group at 2, 4, and 6 months)
   2. Age 7-11 months: never received first dose or is > 8 weeks from last dose (2 doses scheduled in this age group if started at 7 months)
   3. 12-18 months: never received first dose, is >8 weeks from last dose (2 doses scheduled in this age group if started at 12 months) or is due for booster at 12-18 months having received primary series between age 2-11 months.
2. Self-identifies as Orthodox Jewish.
3. Is able to provide informed consent.

Exclusion Criteria:

1. Unable to communicate verbally in English or Yiddish
2. Unwilling or unable to utilize a Yiddish in-person or telephone interpreter
3. Has already participated in this study as an eligible adult or parent. A parent will only be able to participate in this study once (i.e. for only one child in the family that is eligible)
4. Has an appointment at clinic that day to specifically receive vaccines.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peer-led vaccine education intervention; Parents randomized to peer-led vaccine education intervention.	Behavioral: Peer-led vaccine education intervention; The intervention will be delivered face-to-face by a trained peer-educator and will consist of one session of 10-20 minutes. Peer vaccine educators will receive written vaccine materials for distribution. These materials will present content that accurately represents the risks and benefits of vaccination. Responsibilities of the vaccine educators will be to: provide motivational interviewing with patients, provide vaccine counseling, address questions and concerns regarding available vaccines, brief clinical provider on hesitant patients and areas of their vaccine-related concerns, and provide follow-up with participants at day 30, day 60 and day 90 for additional engagement.
No Intervention: Usual Care; Parents randomized to usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Ages 0 Months to 18 Months at Enrollment who Receive at least One Dose of PCV-13 Vaccine by 3 Months Post-Enrollment	Outcome will be determined via review of patient medical chart.	Month 3 Post-Enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Ages 1 Month to 18 Months at Enrollment who Receive at least One Dose of PCV-13 Vaccine by 1 Month Post-Enrollment	Outcome will be determined via review of patient medical chart.	Month 1 Post-Enrollment
Percentage of Days Under-immunized at 3 Months among Participants Ages 0 Months to 18 Months at Enrollment	To obtain the percentage of days underimmunized, investigators will sum the days late across all 4 doses of PCV-13 doses and will divide this by the maximum cumulative number of days a child could be late if they had received no vaccine doses by their age one month post study enrollment. If a dose was never received, the maximum number of days late a child could be for dose will be: age at enrollment in days+31 days minus the latest age in days in which that dose should have been received.	Month 1 Post-Enrollment

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Ellie Carmody, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2022
• Primary Completion (Actual): May 27, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Vaccine confidence
• Other Study ID Numbers: 21-01526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Ellie Carmody, MD, ellie.carmody@nyulangone.org.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to ellie.carmody@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No