Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases

Study Overview
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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).

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

Conditions
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SLE, Rheumatic Diseases, COVID-19 Vaccine, COVID-19

Intervention / Treatment
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* Behavioral: COVID-19 vaccine and booster training, and importance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two different group training arms related to COVID-19 vaccine uptake
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: COVID-19 vaccine and booster training<br>Group training involving COVID-19 vaccine and booster information, including background, development, and myths. | Behavioral: COVID-19 vaccine and booster training, and importance<br>* COVID-19 vaccine and booster information training<br>|
| Experimental: COVID-19 vaccine and booster training with extra nondisclosed component<br>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<br>* COVID-19 vaccine and booster information training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social network, Community based intervention, Vaccine uptake, Popular Opinion Leaders