Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases

NCT ID: NCT05822219

Last Updated: 2025-04-06

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2027-03-30

Brief Summary

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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.

Detailed Description

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Through community-academic partnerships in Boston and Chicago, investigators will recruit and randomly assign POLs who identify as Black with rheumatic conditions to two training arms in each city. Arms 1 and 2 will receive the same core curriculum addressing COVID-19 vaccine hesitancy, safety and efficacy. POLs will work in their communities to distributed information they learned in the trainings to members of their social network. The investigators will gather information about these social networks, assessing for differences in characteristics such as size, location, and who is in it (percentage of family, percentage Black, percentage with rheumatic conditions).

Conditions

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Rheumatic Diseases COVID-19 Vaccine COVID-19 SLE

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two different group training arms related to COVID-19 vaccine uptake
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

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.

Study Groups

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COVID-19 vaccine and booster training

Group training involving COVID-19 vaccine and booster information, including background, development, and myths.

Group Type ACTIVE_COMPARATOR

COVID-19 vaccine and booster training, and importance

Intervention Type BEHAVIORAL

COVID-19 vaccine and booster information training

COVID-19 vaccine and booster training with extra undisclosed component

Group 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.

Group Type EXPERIMENTAL

COVID-19 vaccine and booster training, and importance

Intervention Type BEHAVIORAL

COVID-19 vaccine and booster information training

Interventions

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COVID-19 vaccine and booster training, and importance

COVID-19 vaccine and booster information training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

POLs:

18-85 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.

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Rosalind Ramsey-Goldman

Principal Investigator - Chicago

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rosalind Ramsey-Goldman, MD, DrPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39181556 (View on PubMed)

Sirek 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.

Reference Type DERIVED
PMID: 38458871 (View on PubMed)

Other Identifiers

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ACTIVATE

Identifier Type: -

Identifier Source: org_study_id

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