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NCT Number: NCT06156254

Community Care Intervention to Decrease COVID-19 Vaccination Inequities

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bedford-Stuyvesant Family Health Center, Brooklyn, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

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Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Cassells, MPH

CONTACT

[email protected]

212-382-0699 ext. 227

Jackie Cortez, MPH

CONTACT

[email protected]

212-382-0699 ext. 244

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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