Peer Education as a Strategy to Promote Vaccine Acceptance

NCT05875779 | Completed

• 1 other identifier: 21-01526
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccine Acceptance

Keywords

Vaccine confidence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Percentage of Days Under-immunized at 3 Months among Participants Ages 0 Months to 18 Months at Enrollment

  Month 1 Post-Enrollment

Study Arms (2)

Peer-led vaccine education intervention

EXPERIMENTAL

Parents randomized to peer-led vaccine education intervention.

Behavioral: Peer-led vaccine education intervention

Usual Care

NO INTERVENTION

Parents randomized to usual care.

Interventions

Peer-led vaccine education intervention BEHAVIORAL

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.

Peer-led vaccine education intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)
• 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)
• 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.
• Self-identifies as Orthodox Jewish.
• Is able to provide informed consent.

You may not qualify if:

• Unable to communicate verbally in English or Yiddish
• Unwilling or unable to utilize a Yiddish in-person or telephone interpreter
• 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)
• Has an appointment at clinic that day to specifically receive vaccines.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Grossman School of Medicine, Division of Infectious Diseases

New York, New York, 10016, United States

Location

Related Publications (1)

• Hoffman E, Kahan T, Auerbach E, Brody H, Abramson NN, Haiken S, Shields D, Elyasi A, Ifrah S, Frenkel-Schick A, Zyskind I, Knoll M, Carmody E. Peer education as a strategy to promote vaccine acceptance: A randomized controlled trial within New York community healthcare practices. Vaccine. 2024 Nov 14;42 Suppl 5:126028. doi: 10.1016/j.vaccine.2024.05.076. Epub 2024 Jun 10.

  PMID: 38862308 DERIVED

Study Officials

• Ellie Carmody, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: March 6, 2022
• Primary Completion: May 27, 2023
• Study Completion: August 1, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

US (1)