Clinical trial NCT05875779: Peer Education as a Strategy to Promote Vaccine Acceptance
Official title: Developing Vaccine Educators Within Practices of Community Healthcare Providers: a Pragmatic, Randomized Controlled Trial of Peer Education to Promote Vaccine Acceptance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine Acceptance
Keywords: Vaccine confidence
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 154
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Month 3 Post-Enrollment
Secondary outcomes:
measure: 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
timeFrame: Month 1 Post-Enrollment
measure: Percentage of Days Under-immunized at 3 Months among Participants Ages 0 Months to 18 Months at Enrollment
timeFrame: Month 1 Post-Enrollment
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Grossman School of Medicine, Division of Infectious Diseases
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ellie Carmody, MD
role: PRINCIPAL_INVESTIGATOR
References: