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

The purpose of this study is to find out if a community health workers (CHW) interventionconducted in Federally Qualified Health Centers (FQHCs) can increase the number of adultswith chronic illnesses who are up-to-date with their COVID-19 and influenza vaccines.

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.

Recruiting
COVID-19 Vaccination

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.

Eligibility Criteria

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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Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Morris Heights Health Center
Bronx, New York, United States

Brownsville Multi-Service Health Center
Brooklyn, New York, United States

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

Community Healthcare Network
New York, New York, United States

Contacts

Andrea Cassells, MPH
212-382-0699 - 227
acass@cdnetwork.org

Jackie Cortez, MPH
212-382-0699 ext. 244
CDNresearch5@cdnetwork.org

NCT Number
MeSH Terms
COVID-19