Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases
Leveraging Community-Academic Partnerships and Social Networks to Disseminate Vaccine-Related Information and Increase Vaccine Uptake Among Black Individuals With Rheumatic Diseases.
1 other identifier
interventional
60
1 country
1
Brief Summary
To establish the efficacy of a community-based POL (Popular Opinion Leader) intervention with two different trainings designed to increase COVID-19 vaccine and booster uptake and reduce hesitancy among social networks of Black individuals with rheumatic conditions. The investigators will also determine the structure and composition of the personal and outreach social networks of POLs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2023
CompletedFirst Posted
Study publicly available on registry
April 20, 2023
CompletedStudy Start
First participant enrolled
March 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2027
ExpectedApril 6, 2025
February 1, 2025
2 years
March 20, 2023
April 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Receipt of >1 COVID-19 vaccine or booster dose
This will be measured as documentation of receipt of \>1 additional COVID-19 vaccine or booster dose above network members' baseline number of doses, scored yes or no.
6 months
Secondary Outcomes (2)
Change in COVID-19 vaccine hesitancy
6 months
Structure and composition of the Popular Opinion Leader outreach networks.
6 months
Study Arms (2)
COVID-19 vaccine and booster training
ACTIVE COMPARATORGroup training involving COVID-19 vaccine and booster information, including background, development, and myths.
COVID-19 vaccine and booster training with extra undisclosed component
EXPERIMENTALGroup training involving COVID-19 vaccine and booster information, including background, development, and myths. Contains extra training component that is undisclosed until the end of the study so as not to introduce bias.
Interventions
COVID-19 vaccine and booster information training
Eligibility Criteria
You may qualify if:
- POLs:
- years old; All genders; English-speaking; Self-identify as Black and/or African descent; Received ≥1 dose of a COVID-19 vaccine after 8.31.2022 (bivalent booster or updated COVID-19 vaccine \[2023-2024\] formula)
- Social network members:
- At least 18 years of age; All genders; English-speaking or Haitian Creole or Spanish-speaking if the POL also speaks Haitian Creole or Spanish; Not have received the updated COVID-19 vaccine 2023-2024 formula; Recent (within 3 months) COVID-19 infection and either undecided or no intention of receiving the vaccine.
You may not qualify if:
- Both POLs and social network members:
- Under 18 years of age Pregnant women Institutionalized or incarcerated Those who are up to date on COVID vaccinations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- Brigham and Women's Hospitalcollaborator
- Boston Children's Hospitalcollaborator
- Boston Medical Centercollaborator
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
Related Publications (2)
Sirek G, Erickson D, Muhammad LN, Losina E, Chandler MT, Son MB, Crespo-Bosque M, York M, Jean-Jacques M, Milaeger H, Pillai N, Roberson T, Chung A, Shramuk M, Osaghae E, Williams J, Ojikutu BO, Dhand A, Ramsey-Goldman R, Feldman CH. Community-engaged randomised controlled trial to disseminate COVID-19 vaccine-related information and increase uptake among Black individuals in two US cities with rheumatic conditions. BMJ Open. 2024 Aug 24;14(8):e087918. doi: 10.1136/bmjopen-2024-087918.
PMID: 39181556DERIVEDSirek G, Ulysse S, Jacques Toussaint M, Nosamiefan C, Desrosiers L, Chandler M, Ramsey-Goldman R, Fleurissaint DJ, Feldman CH. A community-engaged approach to translate a Vaccine Hesitancy Scale into Haitian Creole. Vaccine. 2024 Apr 2;42(9):2127-2134. doi: 10.1016/j.vaccine.2024.02.079. Epub 2024 Mar 7.
PMID: 38458871DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rosalind Ramsey-Goldman, MD, DrPH
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Participants are unblinded but study has non-disclosure component of keeping the difference between the two training arms as non-disclosed until the conclusion of the study.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator - Chicago
Study Record Dates
First Submitted
March 20, 2023
First Posted
April 20, 2023
Study Start
March 15, 2024
Primary Completion
March 31, 2026
Study Completion (Estimated)
March 30, 2027
Last Updated
April 6, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Resource sharing will be made available in a timely manner and no later than 12 months after the publication of the main findings from the final data set.
- Access Criteria
- Any investigator who wishes to obtain data from this Project will do so with a Resource Sharing Agreement that provides for 1) a commitment to using the resources only for research purposes and not to identify an individual participant.2) a commitment to securing resources using appropriate computer technology.3) a commitment to destroy or return the resources after analyses are completed.4) cover the cost of preparing data including programming time and other tasks required to transfer the dataset.
The final data sets from this project will include participant reported survey outcomes and will be de-identified in accordance with HIPAA guidelines. Several methods of resource sharing will be employed by this project including:1)Publishing of results in scientific journals and presentation at professional meetings 2)Replies to requests from individuals for data, and sent via secure methods such as password protected files 3)Posting of POL training curriculum after all data are collected on Dr. Ramsey-Goldman's (MPI) NU webpage 4)Posting study-specific adaptations made to social network survey on website of Dr. Dhand (Co-Investigator).