Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases

N/AActive Not RecruitingNCT05822219

Northwestern University60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Rheumatic Diseases COVID-19 Vaccine COVID-19 SLE

Interventions

COVID-19 vaccine and booster training, and importanceBEHAVIORAL

COVID-19 vaccine and booster information training

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Northwestern University

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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

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

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

Data from ClinicalTrials.gov

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