Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05822219
• Other study ID #: ACTIVATE
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: July 31, 2027

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Neil Pillai, MS
• Phone: 312.503.3904
• Email: neil.pillai[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2027
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• COVID-19
• COVID-19 Vaccine
• Rheumatic Diseases
• SLE

Intervention

Behavioral:
• COVID-19 vaccine and booster training, and importance
COVID-19 vaccine and booster information training

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	Boston Children's Hospital, Boston Medical Center, Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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