Rheumatic DiseasesNCT05822219
Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases
A study testing COVID-19 vaccine and booster training, and importance in people with Rheumatic Diseases and COVID-19 Vaccine, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Diseases, COVID-19 Vaccine, COVID-19
- What is being tested?
- COVID-19 vaccine and booster training, and importance
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leveraging Community-Academic Partnerships and Social Networks to Disseminate Vaccine-Related Information and Increase Vaccine Uptake Among Black Individuals With Rheumatic Diseases.
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.
Read the 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).
- Conditions
- Rheumatic Diseases, COVID-19 Vaccine, COVID-19, SLE
- Being tested
- COVID-19 vaccine and booster training, and importance
- Keywords
- Social network, Community based intervention, Vaccine uptake, Popular Opinion Leaders
- Medical subject headings
- Rheumatic Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccine and booster training, and importanceBehavioural
COVID-19 vaccine and booster information training
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 vaccine and booster training | Active comparator | Group training involving COVID-19 vaccine and booster information, including background, development, and myths. Receives: Behavioral: COVID-19 vaccine and booster training, and importance |
| COVID-19 vaccine and booster training with extra undisclosed component | Experimental | 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. Receives: Behavioral: COVID-19 vaccine and booster training, and importance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start15 Mar 2024
- Primary completion1 Apr 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two different group training arms related to COVID-19 vaccine uptake
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosalind Ramsey-Goldman, Northwestern University
- Investigators
- Rosalind Ramsey-Goldman, MD, DrPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822219
- Sponsor's protocol ID
- ACTIVATE
- Status last verified
- May 2026
- First submitted
- 20 Mar 2023
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final data sets from this project will include participant reported survey outcomes and will be de-identified in accordance with HIPAA guidelines. Several methods of resource sharing will be employed by this project including:1)Publishing of results in scientific journals and presentation at professional meetings 2)Replies to requests from individuals for data, and sent via secure methods such as password protected files 3)Posting of POL training curriculum after all data are collected on Dr. Ramsey-Goldman's (MPI) NU webpage 4)Posting study-specific adaptations made to social network survey on website of Dr. Dhand (Co-Investigator).
Publications
Sirek G, Erickson D, Muhammad LN, Losina E, Chandler MT, Son MB, Crespo-Bosque M, York M, Jean-Jacques M, Milaeger H, Pillai N, Roberson T, Chung A, Shramuk M, Osaghae E, Williams J, Ojikutu BO, Dhand A, Ramsey-Goldman R, Feldman CH. Community-engaged randomised controlled trial to disseminate COVID-19 vaccine-related information and increase uptake among Black individuals in two US cities with rheumatic conditions. BMJ Open. 2024 Aug 24;14(8):e087918. doi: 10.1136/bmjopen-2024-087918.
PubMed 39181556Sirek G, Ulysse S, Jacques Toussaint M, Nosamiefan C, Desrosiers L, Chandler M, Ramsey-Goldman R, Fleurissaint DJ, Feldman CH. A community-engaged approach to translate a Vaccine Hesitancy Scale into Haitian Creole. Vaccine. 2024 Apr 2;42(9):2127-2134. doi: 10.1016/j.vaccine.2024.02.079. Epub 2024 Mar 7.
PubMed 38458871
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Community-Academic Partnerships and Social Networks to Disseminate Vaccine-Related Information and Increase Vaccine Uptake Among Black Individuals With Rheumatic Diseases.
- ClinicalTrials.gov ID
- NCT05822219
- Acronym / sponsor ID
- ACTIVATE
- Conditions
- Rheumatic Diseases, COVID-19 Vaccine, COVID-19, SLE
- Keywords
- Social network, Community based intervention, Vaccine uptake, Popular Opinion Leaders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Boston Children's Hospital, Boston Medical Center
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two different group training arms related to COVID-19 vaccine uptake
| Arm | Type | Receives |
|---|---|---|
| COVID-19 vaccine and booster training | Active comparator | Behavioral: COVID-19 vaccine and booster training, and importanceGroup training involving COVID-19 vaccine and booster information, including background, development, and myths. |
| COVID-19 vaccine and booster training with extra undisclosed component | Experimental | Behavioral: COVID-19 vaccine and booster training, and importanceGroup 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
- 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.
Key exclusion criteria (2 listed)
- Under 18 years of age Pregnant women Institutionalized or incarcerated Those who are up to date on COVID vaccinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccine and booster training, and importanceCOVID-19 vaccine and booster information training | Behavioural | COVID-19 vaccine and booster training, COVID-19 vaccine and booster training with extra undisclosed component |
Primary outcome
Receipt of >1 COVID-19 vaccine or booster dose
Time frame: 6 months
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.
2 secondary outcomes
Change in COVID-19 vaccine hesitancy
Time frame: 6 months
Structure and composition of the Popular Opinion Leader outreach networks.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Derived from this study: PubMed 39181556Sirek G, Erickson D, Muhammad LN, Losina E, Chandler MT, Son MB, Crespo-Bosque M, York M, Jean-Jacques M, Milaeger H, Pillai N, Roberson T, Chung A, Shramuk M, Osaghae E, Williams J, Ojikutu BO, Dhand A, Ramsey-Goldman R, Feldman CH. Community-engaged randomised controlled trial to disseminate COVID-19 vaccine-related information and increase uptake among Black individuals in two US cities with rheumatic conditions. BMJ Open. 2024 Aug 24;14(8):e087918. doi: 10.1136/bmjopen-2024-087918.
- Derived from this study: PubMed 38458871Sirek G, Ulysse S, Jacques Toussaint M, Nosamiefan C, Desrosiers L, Chandler M, Ramsey-Goldman R, Fleurissaint DJ, Feldman CH. A community-engaged approach to translate a Vaccine Hesitancy Scale into Haitian Creole. Vaccine. 2024 Apr 2;42(9):2127-2134. doi: 10.1016/j.vaccine.2024.02.079. Epub 2024 Mar 7.
- Individual participant dataSharing planned: Yes. The final data sets from this project will include participant reported survey outcomes and will be de-identified in accordance with HIPAA guidelines. Several methods of resource sharing will be employed by this project including:1)Publishing of results in scientific journals and presentation at professional meetings 2)Replies to requests from individuals for data, and sent via secure methods such as password protected files 3)Posting of POL training curriculum after all data are collected on Dr. Ramsey-Goldman's (MPI) NU webpage 4)Posting study-specific adaptations made to social network survey on website of Dr. Dhand (Co-Investigator).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosalind Ramsey-Goldman, MD, DrPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 vaccine and booster training, and importance in people with Rheumatic Diseases and COVID-19 Vaccine, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of >1 COVID-19 vaccine or booster dose (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05822219, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.