Community Care Intervention to Decrease COVID-19 Vaccination Inequities

NCT ID: NCT06156254

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-21
• Study Completion Date: 2026-06-01

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.

Conditions

COVID-19 Vaccination

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Usual Care

Patients will receive the care that they would usually receive independent of the study but won't have access to the intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

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)

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Directors Network

NETWORK

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

RAND

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marielena Lara, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

RAND

Lisa Meredith, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Jonathan Tobin, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Directors Network

Andrea Cassells, MPH

Role: STUDY_DIRECTOR

Clinical Directors Network

Locations

Brownsville Multi-Service Health Center

Brooklyn, New York, United States

Site Status: NOT_YET_RECRUITING

Bedford-Stuyvesant Family Health Center

Brooklyn, New York, United States

Site Status: RECRUITING

Community Healthcare Network

New York, New York, United States

Site Status: NOT_YET_RECRUITING

Morris Heights Health Center

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Andrea Cassells, MPH

Role: CONTACT

acass@cdnetwork.org

212-382-0699 ext. 227

Jackie Cortez, MPH

Role: CONTACT

CDNresearch5@cdnetwork.org

212-382-0699 ext. 244

Facility Contacts

Center

Role: primary

References

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.

Reference Type: DERIVED

PMID: 39965727 (View on PubMed)

Other Identifiers

R01MD017232

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HCAAD148

Identifier Type: -

Identifier Source: org_study_id