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Active, not recruitingNCT05822219Updated May 29, 2026

Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases

An interventional study of COVID-19 vaccine and booster training, and importance in Rheumatic Diseases, COVID-19 Vaccine and COVID-19, sponsored by Northwestern University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by Northwestern University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
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Study 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.

Read the detailed description

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).

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Conditions studied

  • Rheumatic Diseases
  • COVID-19 Vaccine
  • COVID-19
  • SLE

Keywords

  • Social network
  • Community based intervention
  • Vaccine uptake
  • Popular Opinion Leaders
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In context

Rheumatic Diseases

377 studies on the registry are indexed under Rheumatic Diseases; 79 are open to participants now.

This study's planned enrollment of 60 is below the median of 74 across 210 interventional studies indexed under Rheumatic Diseases.

Browse Rheumatic Diseases studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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

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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    COVID-19 vaccine and booster training

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

    Behavioral: COVID-19 vaccine and booster training, and importance

  • Experimental
    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.

    Behavioral: COVID-19 vaccine and booster training, and importance

Interventions

  • BehavioralCOVID-19 vaccine and booster training, and importance

    COVID-19 vaccine and booster information training

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What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. Change in COVID-19 vaccine hesitancy

    This will be measured as the network members' absolute change in vaccine hesitancy scale score comparing 6 months to baseline between the two study arms, using the validated 10-item Likert Vaccine Hesitancy Scale, score range 10-50.

    Time frame: 6 months

  2. Structure and composition of the Popular Opinion Leader outreach networks.

    A mixed methods social network assessment tool will be used to compare the structures and compositions of the outreach social networks of the Popular Opinion Leaders between the two intervention arms. This is not scored but rather used to create social network map and to understand characteristics of social networks.

    Time frame: 6 months

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Study locations

1 site
  • Northwestern University
    Chicago, Illinois 60611, United States
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References and documents

Publications

  • 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. PubMed 39181556 ↗
  • 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. PubMed 38458871 ↗

Individual participant data

Plan to share: Yes — 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).

Supporting information: Study protocol

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05822219
Lead sponsor
Northwestern University
Collaborators
Brigham and Women's Hospital, Boston Children's Hospital, Boston Medical Center
Responsible party
Rosalind Ramsey-Goldman (Principal Investigator - Chicago, Northwestern University) — Principal investigator
First posted
Apr 20, 2023
Start date
Mar 15, 2024
Primary completion
Apr 1, 2026
Completion
Dec 31, 2027 (estimated)
Last update
May 29, 2026

Study contacts

Rosalind Ramsey-Goldman, MD, DrPH
principal investigator · Northwestern University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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