Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases

March 13, 2024 updated by: Rosalind Ramsey-Goldman, Northwestern University

Leveraging Community-Academic Partnerships and Social Networks to Disseminate Vaccine-Related Information and Increase Vaccine Uptake Among Black Individuals With Rheumatic Diseases.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 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
COVID-19 vaccine and booster information training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receipt of >1 COVID-19 vaccine or booster dose
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in COVID-19 vaccine hesitancy
Time Frame: 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.
6 months
Structure and composition of the Popular Opinion Leader outreach networks.
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Boston Children's Hospital
Brigham and Women's Hospital
Boston Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2024

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

April 7, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTIVATE (Immune Tolerance Network)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on COVID-19 vaccine and booster training, and importance

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe