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Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases

Primary Purpose

Rheumatic Diseases, COVID-19 Vaccine, COVID-19

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COVID-19 vaccine and booster training, and importance
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rheumatic Diseases focused on measuring Social network, Community based intervention, Vaccine uptake, Popular Opinion Leaders

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: POLs: 18-85 years old All genders English-speaking Self-identify as Black and/or African American and/or African descent (Dominican, Haitian) Any ethnicity Social network members: At least 18 years of age All genders English-speaking or Haitian Creole or Spanish-speaking 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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

COVID-19 vaccine and booster training

COVID-19 vaccine and booster training with extra nondisclosed component

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 20, 2023
Last Updated
October 12, 2023
Sponsor
Northwestern University
Collaborators
Brigham and Women's Hospital, Boston Children's Hospital, Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05822219
Brief Title
Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases
Official Title
Leveraging Community-Academic Partnerships and Social Networks to Disseminate Vaccine-Related Information and Increase Vaccine Uptake Among Black Individuals With Rheumatic Diseases.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
April 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Brigham and Women's Hospital, Boston Children's Hospital, Boston Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Diseases, COVID-19 Vaccine, COVID-19, SLE
Keywords
Social network, Community based intervention, Vaccine uptake, Popular Opinion Leaders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two 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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 vaccine and booster training
Arm Type
Active Comparator
Arm Description
Group training involving COVID-19 vaccine and booster information, including background, development, and myths.
Arm Title
COVID-19 vaccine and booster training with extra nondisclosed component
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
COVID-19 vaccine and booster training, and importance
Intervention Description
COVID-19 vaccine and booster information training
Primary Outcome Measure Information:
Title
Receipt of >1 COVID-19 vaccine or booster dose
Description
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 Outcome Measure Information:
Title
Change in COVID-19 vaccine hesitancy
Description
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
Title
Structure and composition of the Popular Opinion Leader outreach networks.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: POLs: 18-85 years old All genders English-speaking Self-identify as Black and/or African American and/or African descent (Dominican, Haitian) Any ethnicity Social network members: At least 18 years of age All genders English-speaking or Haitian Creole or Spanish-speaking 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neil Pillai, MS
Phone
312.503.3904
Email
neil.pillai@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Holly R. Milaeger, MPH
Phone
312.503.0251
Email
holly.milaeger@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosalind Ramsey-Goldman, MD, DrPH
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosalind Ramsey-Goldman
Phone
312-503-0542
Email
rgramsey@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Neil Pillai, MS
Phone
3125030542
Email
rgramsey@northwestern.edu

12. IPD Sharing Statement

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Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases

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