Vaccine Confidence Study Among Historically Marginalized Racial and Ethnic Groups

NCT ID: NCT06639386

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vaccine Hesitancy Vaccine Refusal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Stransky, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center, Pediatrics

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michelle Stransky, PhD

Role: CONTACT

617-414-6399

Maria P Gomez, BA

Role: CONTACT

617-414-6399

Facility Contacts

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Michelle Stransky, PhD

Role: primary

617-414-7424

Other Identifiers

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H-44825

Identifier Type: -

Identifier Source: org_study_id

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