Clinical trial NCT06156254: Community Care Intervention to Decrease COVID-19 Vaccination Inequities
Official title: Impact of a Community Care Intervention to Address Inequities in COVID-19 and Influenza Vaccination Among Adults Suffering From Disproportionate Chronic Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19 Vaccination
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Clinical Directors Network
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-12-05
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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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Primary outcomes:
measure: COVID-19 vaccine acceptance
timeFrame: Baseline and 3 months
measure: COVID-19 vaccine uptake
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Influenza vaccine uptake
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Morris Heights Health Center
state: New York
city: Brooklyn
country: United States
facility: Brownsville Multi-Service Health Center
state: New York
city: Brooklyn
country: United States
facility: Bedford-Stuyvesant Family Health Center
state: New York
city: New York
country: United States
facility: Community Healthcare Network
state: New York
Study officials:
affiliation: RAND
name: Marielena Lara, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: RAND
name: Lisa Meredith, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Directors Network
name: Jonathan Tobin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Directors Network
name: Andrea Cassells, MPH
role: STUDY_DIRECTOR
References: