Vaccine Confidence Study Among Historically Marginalized Racial and Ethnic Groups

NCT06639386 | Recruiting

• 1 other identifier: H-44825
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaccine Hesitancy; Vaccine Refusal

Keywords

Vaccine confidence; Marginalized populations; MMR vaccine; RSV vaccine

Outcome Measures

Primary Outcomes (3)

• 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.

  12 months

• 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.

  12 months

• 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.

  12 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Vaccination Hesitancy; Vaccination Refusal

Condition Hierarchy (Ancestors)

Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Michelle Stransky, PhD

  Boston Medical Center, Pediatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Stransky, PhD

CONTACT

617-414-6399; mlstrans@bu.edu

Maria P Gomez, BA

CONTACT

617-414-6399; Maria.GomezCampo@bmc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: January 31, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

US (1)