Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05822219
Collaborator
Brigham and Women's Hospital (Other), Boston Children's Hospital (Other), Boston Medical Center (Other)
60
1
2
48
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: COVID-19 vaccine and booster training, and importance
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two different group training arms related to COVID-19 vaccine uptakeTwo different group training arms related to COVID-19 vaccine uptake
Masking:
None (Open Label)
Masking Description:
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.
Primary Purpose:
Health Services Research
Official Title:
Leveraging Community-Academic Partnerships and Social Networks to Disseminate Vaccine-Related Information and Increase Vaccine Uptake Among Black Individuals With Rheumatic Diseases.
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Apr 30, 2027

Arms and Interventions

Arm Intervention/Treatment
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
COVID-19 vaccine and booster information training

Experimental: COVID-19 vaccine and booster training with extra nondisclosed 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
COVID-19 vaccine and booster information training

Outcome Measures

Primary Outcome Measures

  1. Receipt of >1 COVID-19 vaccine or booster dose [6 months]

    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.

Secondary Outcome Measures

  1. Change in COVID-19 vaccine hesitancy [6 months]

    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.

  2. Structure and composition of the Popular Opinion Leader outreach networks. [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
POLs:

18-85 years old All genders English-speaking Self-identify as Black Any ethnicity

Social network members:

At least 18 years of age All genders English-speaking or Haitian Creole or Spanish if the POL speaks Spanish Not be fully vaccinated

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University
  • Brigham and Women's Hospital
  • Boston Children's Hospital
  • Boston Medical Center

Investigators

  • Principal Investigator: Rosalind Ramsey-Goldman, MD, DrPH, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rosalind Ramsey-Goldman, Principal Investigator - Chicago, Northwestern University
ClinicalTrials.gov Identifier:
NCT05822219
Other Study ID Numbers:
  • ACTIVATE
First Posted:
Apr 20, 2023
Last Update Posted:
Apr 20, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rosalind Ramsey-Goldman, Principal Investigator - Chicago, Northwestern University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2023