Clinical trial NCT06639386: Vaccine Confidence Study Among Historically Marginalized Racial and Ethnic Groups
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vaccine Hesitancy
Vaccine Refusal
Keywords: Vaccine confidence
Marginalized populations
MMR vaccine
RSV vaccine
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2024-10-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Vaccine confidence from the parents' perspective
timeFrame: 12 months
measure: Vaccine confidence from the clinicians' perspective
timeFrame: 12 months
measure: Vaccine confidence from the EBI Experts' perspective
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Pediatrics
name: Michelle Stransky, PhD
role: PRINCIPAL_INVESTIGATOR
References: