Peer Education as a Strategy to Promote Vaccine Acceptance

Vaccine Acceptance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05875779
• Other study ID #: 21-01526
• Status: Completed
• Phase: N/A
• Start date: March 6, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: August 1, 2023
• Est. primary completion date: May 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Vaccine Acceptance

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.

Locations

Country	Name	City	State
United States	NYU Grossman School of Medicine, Division of Infectious Diseases	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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