Community Care Intervention to Decrease COVID-19 Vaccination Inequities
Impact of a Community Care Intervention to Address Inequities in COVID-19 and Influenza Vaccination Among Adults Suffering From Disproportionate Chronic Disease
2 other identifiers
interventional
800
1 country
4
Brief Summary
The purpose of this study is to find out if a community health workers (CHW) intervention conducted in Federally Qualified Health Centers (FQHCs) can increase the number of adults with chronic illnesses who are up-to-date with their COVID-19 and influenza vaccines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 21, 2023
CompletedFirst Submitted
Initial submission to the registry
November 29, 2023
CompletedFirst Posted
Study publicly available on registry
December 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
May 13, 2025
May 1, 2025
2.7 years
November 29, 2023
May 7, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
COVID-19 vaccine acceptance
COVID-19 vaccine acceptance at 3 months is measured by a survey self-report survey item asking participants to rate the following statement on a 5-to Likert scale (from 1 = strongly disagree to 5 = strongly agree): "If I was not up-to-date with the COVID-19 vaccines recommended for me, I would get the missing vaccinations." This variable is dichotomized to COVID-19 vaccine acceptance (0 = strongly disagree/disagree/neutral; 1 = agree/strongly agree)
Baseline and 3 months
COVID-19 vaccine uptake
COVID-19 vaccine uptake is defined based on information gathered by multiple sources combining data obtained from patient survey self-reports, EHR data, and Healthix data. We also confirm receipt of the vaccine by asking the participant to see their COVID-19 vaccination card. Vaccination extracted data is from Healthix, the largest Regional Health Information Organization (RHIO) and from a wide array of facilities providing vaccinations will be pulled, including hospitals, health centers, ambulatory care sites, community vaccination sites, and pharmacies.
Baseline and 3 months
Secondary Outcomes (1)
Influenza vaccine uptake
Baseline and 3 months
Study Arms (2)
Community Health Worker (CHW) Intervention to Enhance Vaccination Behavior
EXPERIMENTALPatients randomized to the CHW intervention will receive up to 3 psychoeducational sessions in English or Spanish targeting the specific reason(s) why a patient is not up to date with their COVID-19 vaccine. CHWs will use motivational interviewing techniques to promote vaccination behaviors.
Usual Care
NO INTERVENTIONPatients will receive the care that they would usually receive independent of the study but won't have access to the intervention.
Interventions
Patients randomized to the CHW intervention will receive up to 3 psychoeducational sessions in English or Spanish targeting the specific reason(s) why a patient is not up to date with their COVID-19 vaccine. CHWs will use motivational interviewing techniques to promote vaccination behaviors.
Eligibility Criteria
You may not qualify if:
- Eligibility criteria: Have received a COVID-19 vaccine but not received an updated COVID-19 vaccine at the time of recruitment AND self-report being told by a physician they have one of the following health conditions; high blood pressure/hypertension OR diabetes OR asthma OR overweight/obese OR a one of the following mental health condition (probable depression, probable generalized anxiety, or probable PTSD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RANDlead
- Clinical Directors Networkcollaborator
- National Institute on Minority Health and Health Disparities (NIMHD)collaborator
Study Sites (4)
Brownsville Multi-Service Health Center
Brooklyn, New York, 11212, United States
Bedford-Stuyvesant Family Health Center
Brooklyn, New York, 11216, United States
Community Healthcare Network
New York, New York, 10010, United States
Morris Heights Health Center
The Bronx, New York, 10453, United States
Related Publications (1)
Meredith LS, Tobin JN, Cassells A, Howell K, Hernandez HG, Gidengil C, Williamson S, Dong L, Timmins G, Alvarado G, Holder T, Cortez Lainez J, Lin TJ, Lara M. Boost your health (Refuerza tu Salud): Design of a randomized controlled trial of a community health worker intervention to reduce inequities in COVID-19 and influenza vaccinations. Contemp Clin Trials. 2025 Jun;153:107848. doi: 10.1016/j.cct.2025.107848. Epub 2025 Feb 16.
PMID: 39965727DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Marielena Lara, MD, MPH
RAND
- PRINCIPAL INVESTIGATOR
Lisa Meredith, PhD
RAND
- PRINCIPAL INVESTIGATOR
Jonathan Tobin, PhD
Clinical Directors Network
- STUDY DIRECTOR
Andrea Cassells, MPH
Clinical Directors Network
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2023
First Posted
December 5, 2023
Study Start
September 21, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be available by the completion of the study on 2/28/27
- Access Criteria
- The study's deidentified participant-level data will be made publicly available
We will deposit deidentified participant-level data, survey instruments, and variable descriptions to the NIMH Data Archive in accordance with the NIH Data Management and Sharing Policy.