Vaccine HesitancyNCT06639386
Vaccine Confidence Study Among Historically Marginalized Racial and Ethnic Groups
An observational study of Vaccine Hesitancy and Vaccine Refusal, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy, Vaccine Refusal
- Type of treatment
- Vaccines
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Medical subject headings
- Vaccination Hesitancy, Vaccination Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start31 Jan 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine HesitancyStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Michelle Stransky, PhD, Principal investigator, Boston Medical Center, Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639386
- Sponsor's protocol ID
- H-44825
- Status last verified
- Jul 2026
- First submitted
- 10 Oct 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06639386
- Acronym / sponsor ID
- H-44825
- Conditions
- Vaccine Hesitancy, Vaccine Refusal
- Keywords
- Vaccine confidence, Marginalized populations, MMR vaccine, RSV vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vaccine confidence from the parents' perspective
Time frame: 1 day
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.
Vaccine confidence from the clinicians' perspective
Time frame: 1 day
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.
Vaccine confidence from the EBI Experts' perspective
Time frame: 1 day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Stransky, PhD principal investigator
Boston Medical Center, Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Hesitancy and Vaccine Refusal, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine confidence from the parents' perspective (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.