Community Care Intervention to Decrease COVID-19 Vaccination Inequities

May 12, 2026 updated by: RAND

Impact of a Community Care Intervention to Address Inequities in COVID-19 and Influenza Vaccination Among Adults Suffering From Disproportionate Chronic Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Many factors contribute to inequities in vaccination rates among racial and ethnic minorities, including differences in vaccine acceptance and intention and related variability in social behavioral norms, knowledge, risk perception, trust, and structural barriers. The World Health Organization has called for community health workers (CHWs) as a key strategy to address vaccination inequities among vulnerable populations worldwide. CHWs are trusted messengers and cultural brokers that can address barriers to vaccination access and provide language, culturally, and literacy-appropriate information to promote awareness of and motivation to partake in protective vaccination behaviors. CHWs can have a central role in Federally Qualified Health Centers (FQHCs) by helping link their mostly non-White patients with health care and community resources.

This study examines whether a CHW intervention can be effective in increasing vaccination rates by providing education, help with behavior changes, and assistance in navigating barriers to increase equal access to vaccination. The CHW intervention consists of 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. According to the reason(s), the CHW implements strategies to educate, motivate, and help navigate any access barriers to getting vaccinated. CHWs use motivational interviewing techniques to encourage patients to get vaccinated. Patients also receive educational flyers designed by a local artist addressing their own COVID-19 vaccination knowledge gaps. Toward the end of each session, the CHW works with the patient to create a Patient Action Plan with steps the patient can take to overcome their barriers to vaccination.

RAND and Clinical Directors Network (CDN) are conducting a randomized controlled trial (RCT) in New York City FHQCs to determine the efficacy of the CHW intervention to improve vaccine acceptance and uptake among racial/ethnic minority adults with any of 7 chronic conditions (asthma, diabetes, hypertension, obesity, depression, anxiety disorder, or PTSD). This research study plans to randomly assign (like the flip of a coin) a total of 800 patients to a "Usual Care Group" (400 patients who will continue to receive usual care with no changes) or "CHW Group" (400 patients who will receive the CHW intervention and usual care).

The following four research questions guide the study:

  • What makes being up to date for COVID and Flu vaccines difficult for people with chronic illness?
  • Can a CHW intervention help patients be up to date with the COVID and Flu vaccines?
  • What about the CHW intervention specifically works for different types of patients?
  • What can help expand the CHW program to more people for a longer time?

The main study hypothesis is that participants assigned to the intervention will exhibit significantly higher vaccine acceptance and actual increases in vaccination rates.

If the intervention is effective, it has the potential to decrease disparities in severe illness resulting from COVID-19 and influenza by increasing vaccination rates among racial and ethnic minority populations with chronic illness. Since FQHCs employ CHWs to help deliver care to patients with chronic illnesses, the intervention would be easily implementable and scalable for future COVID-19 and influenza vaccination seasons.

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11212
        • Not yet recruiting
        • Brownsville Multi-Service Health Center
        • Contact:
          • Center
      • Brooklyn, New York, United States, 11216
        • Recruiting
        • Bedford-Stuyvesant Family Health Center
      • New York, New York, United States, 10010
        • Not yet recruiting
        • Community Healthcare Network
      • The Bronx, New York, United States, 10453
        • Recruiting
        • Morris Heights Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:18 years or older AND speak English or Spanish AND have no obvious physical or cognitive impairment that would make them unable to complete the assessment (as indicated by confusion or inability to understand the questions).

Exclusion Criteria: not willing to consent OR acutely sick OR have high suicide risk

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)

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Community Health Worker (CHW) Intervention to Enhance Vaccination Behavior
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.
Behavioral: Community Health Worker Intervention to Enhance Vaccination Behavior (CHW-VB)
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.
No Intervention: Usual Care
Patients will receive the care that they would usually receive independent of the study but won't have access to the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 vaccine acceptance
Time Frame: Baseline and 3 months
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
Time Frame: Baseline and 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influenza vaccine uptake
Time Frame: Baseline and 3 months
As for COVID-19 update, we rely on a combination of survey self-report, EHR, and Healthix data.
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RAND

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
Clinical Directors Network

Investigators

  • Principal Investigator: Jonathan Tobin, PhD, Clinical Directors Network
  • Principal Investigator: Marielena Lara, MD, MPH, RAND
  • Principal Investigator: Lisa Meredith, PhD, RAND
  • Study Director: Andrea Cassells, MPH, Clinical Directors Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCAAD148
  • R01MD017232 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be available by the completion of the study on 2/28/27

IPD Sharing Access Criteria

The study's deidentified participant-level data will be made publicly available

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19 Vaccination

Clinical Trials on Community Health Worker Intervention to Enhance Vaccination Behavior (CHW-VB)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe