COVID-19 VaccinationNCT06156254
Community Care Intervention to Decrease COVID-19 Vaccination Inequities
A study testing Community Health Worker Intervention to Enhance Vaccination Behavior (CHW-VB) in people with COVID-19 Vaccination, run by RAND at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Vaccination
- What is being tested?
- Community Health Worker Intervention to Enhance Vaccination Behavior (CHW-VB)
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Sep 2023to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
-
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Brownsville Multi-Service Health Center
Brooklyn, New York, 11212
Bedford-Stuyvesant Family Health Center
Brooklyn, New York, 11216
Community Healthcare Network
New York, New York, 10010
Morris Heights Health Center
The Bronx, New York, 10453
About this study
Official title: 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.
Read the 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
- Being tested
- Community Health Worker Intervention to Enhance Vaccination Behavior (CHW-VB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker Intervention to Enhance Vaccination Behavior (CHW-VB)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker (CHW) Intervention to Enhance Vaccination Behavior | Experimental | 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. Receives: Behavioral: Community Health Worker Intervention to Enhance Vaccination Behavior (CHW-VB) |
| Usual Care | No intervention | Patients will receive the care that they would usually receive independent of the study but won't have access to the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 vaccine acceptance
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)
Measured: Baseline and 3 months
COVID-19 vaccine uptake
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.
Measured: Baseline and 3 months
Secondary outcomes (1)
Influenza vaccine uptake
As for COVID-19 update, we rely on a combination of survey self-report, EHR, and Healthix data.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start21 Sep 2023
- Primary completion21 Mar 2026
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Directors Network, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Marielena Lara, MD, MPH, Principal investigator, RANDLisa Meredith, PhD, Principal investigator, RANDJonathan Tobin, PhD, Principal investigator, Clinical Directors NetworkAndrea Cassells, MPH, Study director, Clinical Directors Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156254
- Sponsor's protocol ID
- HCAAD148
- Other IDs
- R01MD017232
- Status last verified
- Aug 2026
- First submitted
- 29 Nov 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39965727
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Community Care Intervention to Address Inequities in COVID-19 and Influenza Vaccination Among Adults Suffering From Disproportionate Chronic Disease
- ClinicalTrials.gov ID
- NCT06156254
- Acronym / sponsor ID
- HCAAD148
- Conditions
- COVID-19 Vaccination
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Clinical Directors Network, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 21 Mar 2026 (actual)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker (CHW) Intervention to Enhance Vaccination Behavior | Experimental | 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. |
| Usual Care | No intervention | –Patients will receive the care that they would usually receive independent of the study but won't have access to the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Community Health Worker (CHW) Intervention to Enhance Vaccination Behavior |
Primary outcome
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)
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.
1 secondary outcome
Influenza vaccine uptake
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 39965727Meredith 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marielena Lara, MD, MPH principal investigator
RAND
Lisa Meredith, PhD principal investigator
RAND
Jonathan Tobin, PhD principal investigator
Clinical Directors Network
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker Intervention to Enhance Vaccination Behavior (CHW-VB) in people with COVID-19 Vaccination, run by RAND at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 vaccine acceptance (time frame: Baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06156254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.