Peer Education as a Strategy to Promote Vaccine Acceptance

Not Applicable

Completed

• Conditions: Vaccine Acceptance
• Interventions: Behavioral: Peer-led vaccine education intervention

• Registration Number: NCT05875779
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-06
• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-25
• Primary Completion: 2023-05-27
• Status Verified: 2023-08
• Study Completion: 2023-08-01
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer-led vaccine education intervention	Peer-led vaccine education intervention	Parents randomized to peer-led vaccine education intervention.

Primary Outcome Measures

Name	Time	Method
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	Month 3 Post-Enrollment	Outcome will be determined via review of patient medical chart.

Secondary Outcome Measures

Name	Time	Method
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	Month 1 Post-Enrollment	Outcome will be determined via review of patient medical chart.
Percentage of Days Under-immunized at 3 Months among Participants Ages 0 Months to 18 Months at Enrollment	Month 1 Post-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.

Trial Locations

Locations (1)

NYU Grossman School of Medicine, Division of Infectious Diseases; 🇺🇸 New York, New York, United States