Vaccine Confidence Study Among Historically Marginalized Racial and Ethnic Groups

Examining Underlying Factors and Root Cause of Successful Evidence Based Interventions (EBIs) Among Historically Marginalized Racial and Ethnic Groups Using the Consolidated Framework for Implementation Research (CFIR)

Achieving optimal vaccination rates is vital for protecting the health and well-being of all individuals. This specific study focuses on the MMR and RSV vaccines in pregnancy and early childhood, which have been shown to reduce RSV and MMR-related illnesses, hospitalizations, and deaths. Efforts to improve vaccination rates have not been equally effective across the entire population; this has resulted in poorer outcomes from interventions for certain populations who are vaccine-hesitant.

This study seeks to understand how to best increase vaccine confidence in marginalized populations. To do this, the investigators will interview parents of children who receive care at Boston Medical Center (BMC), Community Health Workers and other Clinical providers at BMC, leading experts in the fields of vaccine confidence and implementation science, and key public health stakeholders/officials.

Study Overview

• Status: Recruiting
• Conditions: Vaccine Hesitancy; Vaccine Refusal

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Maria P Gomez, BA; Phone Number: 617-414-6399; Email: Maria.GomezCampo@bmc.org
• Study Contact Backup: Name: Michelle Stransky, PhD; Phone Number: 617-414-6399; Email: Michelle.Stransky@bmc.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center
      • Contact: Michelle Stransky, PhD; Phone Number: 617-414-7424; Email: Michelle.Stransky@bmc.org

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The population of 30 adult parents of children 12-24 months will be identified from a clinical database of patients registered at Boston Medical Center (BMC).

The 35 clinicians will be identified from from Pediatrics, Family Medicine, or obstetrics and gynecology (OB/GYN) at BMC. The sample will include 20 Community Health Workers, 10 pediatric/family Medicine clinicians, and 5 Obstetricians. Recruitment will focus on clinicians who have a history of successful vaccine-specific Evidence-Based Interventions (EBIs) beyond BMC and its affiliated CHCs.

The 15 evidence based interventions (EBI) experts will be identified from a review of published peer-review articles in the fields of vaccine EBIs, implementation science, and prenatal genetic counseling.

Description

Inclusion Criteria:

Parent and child-

• The birthing parent of any age of a child (aged 12-24 months) who receives primary care at Boston Medical Center
• A birthing parent who is registered as a patient at Boston Medical Center
• The birthing parent must have been pregnant between the months of October and February (RSV season)
• The birthing parent must be comfortable completing an interview in English, Spanish, or Haitian Creole.

Clinician

• Clinical provider (including Community Health Workers, Physicians, Physician Assistants and Nurse Practitioners) aged 18+ years at Boston Medical Center within Pediatrics, Family Medicine, or OB/GYN. These clinicians will have been involved in past or current successful vaccine-specific Evidence Based Interventions (EBI) beyond BMC and its affiliated Community Health Center (CHC).

EBI Expert

• Content experts (aged 18+ years) in the areas of Implementation Science, Vaccine-specific EBIs, and Prenatal genetic counseling

Exclusion Criteria:

• Clinical provider (including Community Health Workers, Physicians, Physician Assistants and Nurse Practitioners) at NON-BMC clinic/Community Health Center
• Content experts - NON-Vaccine evidence based interventions (EBIs)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Parents of children 12-24 months; 30 birthing parents and their 12-24 month old infants will be enrolled into the study. Study activities (enrollment and interviews) can be conducted with participants in English, Haitian Creole, or Spanish.
Clinicians; 35 clinicians at BMC will be recruited to participate in anonymous, one-time interviews. The sample will include 20 Community Health Workers, 10 pediatric/family Medicine clinicians, and 5 Obstetricians. Recruitment will focus on clinicians who have a history of successful vaccine-specific Evidence-Based Interventions (EBIs) beyond BMC and its affiliated CHCs.
Evidence Based Intervention (EBI) Experts; 15 EBI Experts will be identified from a literature review of published peer-review articles in the fields of vaccine EBIs, implementation science, and prenatal genetic counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine confidence from the parents' perspective	Interviews will be conducted with parents and themes will be abstracted that relate to vaccine confidence. Counts of participants for each theme will be reported.	1 day
Vaccine confidence from the clinicians' perspective	Interviews will be conducted with clinicians and themes will be abstracted that relate to vaccine confidence. Counts of participants for each theme will be reported.	1 day
Vaccine confidence from the EBI Experts' perspective	Interviews will be conducted with EBI experts and themes will be abstracted that relate to vaccine confidence. Counts of participants for each theme will be reported.	1 day

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Michelle Stransky, PhD, Boston Medical Center, Pediatrics

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: MMR vaccine; Vaccine confidence; RSV vaccine; Marginalized populations
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Treatment Refusal; Vaccination Refusal; Vaccination Hesitancy
• Other Study ID Numbers: H-44825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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