Clinical trial NCT05822219: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rheumatic Diseases
COVID-19 Vaccine
COVID-19
SLE
Keywords: Social network
Community based intervention
Vaccine uptake
Popular Opinion Leaders
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Boston Children's Hospital
name: Boston Medical Center
First posted: 2023-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two different group training arms related to COVID-19 vaccine uptake
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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

Primary outcomes:
measure: Receipt of >1 COVID-19 vaccine or booster dose
timeFrame: 6 months
Secondary outcomes:
measure: Change in COVID-19 vaccine hesitancy
timeFrame: 6 months
measure: Structure and composition of the Popular Opinion Leader outreach networks.
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Rosalind Ramsey-Goldman, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
References: