AzTrials
AzTrials

COVID 19Phase 2NCAP2NCT06614361

Community-based Behavioral Intervention to Increase Vaccination Using MOST

A Phase 2 study testing Health education on COVID and flu vaccination, Nurse-led shared decision-making and Text messages in people with COVID 19 and Influenza, run by New York University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The proposed study responds to the need for community-engaged interventions to increase vaccine uptake among populations experiencing health disparities. We focus on COVID-19 and influenza vaccination, both of which now require annual vaccines. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
COVID 19, Influenza
What is being tested?
Health education on COVID and flu vaccination, Nurse-led shared decision-making and Text messages
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Apr 2025to 1 Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • -

About this study

Official title: Community-based Behavioral Intervention to Increase COVID-19 and Influenza Vaccination for African American/ Black and Latino Persons: An Optimization Randomized Controlled Trial

The proposed study responds to the need for community-engaged interventions to increase vaccine uptake among populations experiencing health disparities. We focus on COVID-19 and influenza vaccination, both of which now require annual vaccines. Among those at highest risk for morbidity, hospitalization, and mortality are African American/Black and Latino (ABBL) persons who are not up-to-date on these vaccinations. Only 20-28% of adult AABL persons are up-to-date on COVID-19 vaccination, compared to 31% of White persons, and only 30-40% of AABL persons receive the influenza vaccine annually compared to \>55% among White persons. AABL experience serious impediments to COVID-19 (and to a lesser extent, influenza) vaccination at individual- (e.g., distrust, insufficient knowledge, low perceived risk, cognitive biases), social- (e.g., peer norms), and structural-levels of influence (e.g., poor access). Taken together, these comprise multi-level vaccine hesitancy. Factors that promote vaccination include trusted AABL health educators (peers, nurses), tapping into altruism and collective responsibility, circumventing cognitive biases, and reducing structural barriers. Without efforts to address multi-level vaccine hesitancy, rates of COVID-19 and influenza vaccination will remain unacceptably low and racial/ethnic health disparities in infectious disease morbidity and mortality will persist. The proposed study is led by a collaborative team at New York University and the Northern Manhattan Improvement Corporation. It uses the multiphase optimization strategy (MOST), an engineering-inspired framework, to test effects of individual candidate intervention components in a factorial design and then optimize a multi-component intervention made up of the most cost-effective combination of components. Staying up-to-date with COVID-19 vaccination (confirmed with documentary evidence) is the primary outcome, and influenza vaccination is the secondary outcome. We have identified four promising candidate components, with an emphasis on brevity, low-touch, and future scalability: A) nurse-led shared decision making, B) a text message intervention, C) modest lottery prizes for vaccination, and D) peer navigation to vaccination appointments. Participants will be N=560 community-residing adult English and Spanish-speaking AABL persons who are not up-to-date on COVID-19 and influenza vaccinations but with at least one COVID-19 vaccine dose.

Read the detailed description

The proposed study responds to the need for community-engaged interventions to increase vaccine uptake among populations experiencing health disparities. We focus on COVID-19 and influenza vaccination, both of which now require annual vaccines. Among those at highest risk for morbidity, hospitalization, and mortality are African American/Black and Latino (ABBL) persons who are not up-to-date on these vaccinations. Only 20-28% of adult AABL persons are up-to-date on COVID-19 vaccination, compared to 31% of White persons, and only 30-40% of AABL persons receive the influenza vaccine annually compared to \>55% among White persons. AABL experience serious impediments to COVID-19 (and to a lesser extent, influenza) vaccination at individual- (e.g., distrust, insufficient knowledge, low perceived risk, cognitive biases), social- (e.g., peer norms), and structural-levels of influence (e.g., poor access). Taken together, these comprise multi-level vaccine hesitancy. Factors that promote vaccination include trusted AABL health educators (peers, nurses), tapping into altruism and collective responsibility, circumventing cognitive biases, and reducing structural barriers. Without efforts to address multi-level vaccine hesitancy, rates of COVID-19 and influenza vaccination will remain unacceptably low and racial/ethnic health disparities in infectious disease morbidity and mortality will persist. The proposed study is led by a collaborative team at New York University and the Northern Manhattan Improvement Corporation. It uses the multiphase optimization strategy (MOST), an engineering-inspired framework, to test effects of individual candidate intervention components in a factorial design and then optimize a multi-component intervention made up of the most cost-effective combination of components. Staying up-to-date with COVID-19 vaccination (confirmed with documentary evidence) is the primary outcome, and influenza vaccination is the secondary outcome. We have identified four promising candidate components, with an emphasis on brevity, low-touch, and future scalability: A) nurse-led shared decision making, B) a text message intervention, C) modest lottery prizes for vaccination, and D) peer navigation to vaccination appointments. Participants will be N=560 community-residing adult English and Spanish-speaking AABL persons who are not up-to-date on COVID-19 and influenza vaccinations but with at least one COVID-19 vaccine dose. Specific aims are: Aim 1) identify which of four components contribute meaningfully to improvement in the outcomes; Aim 2) identify mediators (e.g., altruism, norms) and moderators (e.g., sociodemographic characteristics, distrust) of the effects of each component; and Aim 3) build the most cost-effective intervention package(s). Participants will be randomly assigned to an experimental condition, and assessed at 3- and 6-months post-baseline; N=45 participants will engage in qualitative in-depth interviews. We will also uncover, describe, and plan for implementation issues so the optimized intervention can be rapidly scaled up by community-based and outpatient health organizations.

Conditions
COVID 19, Influenza
Being tested
Health education on COVID and flu vaccination, Nurse-led shared decision-making, Text messages, Lottery prize for vaccination, Peer navigation
Keywords
COVID-19, influenza, vaccination
Medical subject headings
COVID-19, Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health education on COVID and flu vaccinationBehavioural

    1 session (30 min) with a health educator on vaccination

  • Nurse-led shared decision-makingBehavioural

    1 session and FU calls with a trained nurse

  • Text messagesBehavioural

    Health \& wellness interactive text message (TM) intervention (12 weeks, 2 texts/week)

  • Lottery prize for vaccinationBehavioural

    Modest lottery prize for COVID vaccination

  • Peer navigationBehavioural

    Peer navigation (4 months duration, contact as needed).

Study groups in NCT06614361
Study groupRoleWhat they receive
Experimental Condition 1ExperimentalCore session
Receives: Behavioral: Health education on COVID and flu vaccination
Experimental Condition 12ExperimentalCore session, nurse-led SDM
Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making; Behavioral: Text messages; Behavioral: Peer navigation
Experimental Condition 3ExperimentalCore session, Text messages
Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Text messages
Experimental Condition 4ExperimentalCore session, nurse-led SDM, text messages
Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making; Behavioral: Text messages
Experimental Condition 5ExperimentalCore, lottery prize
Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Lottery prize for vaccination
Experimental Condition 6ExperimentalCore session, nurse-led SDM, lottery prize
Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making; Behavioral: Lottery prize for vaccination
Experimental Condition 7ExperimentalCore, text messages, lottery prize
Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Text messages; Behavioral: Lottery prize for vaccination
Experimental Condition 8ExperimentalCore, nurse-led SDM, text messages, lottery prize
Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making; Behavioral: Text messages; Behavioral: Lottery prize for vaccination
Experimental Condition 9ExperimentalCore, peer navigation
Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Peer navigation
Experimental Condition 10ExperimentalCore, nurse-led SDM, peer navigation
Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making; Behavioral: Peer navigation
Experimental Condition 11Experimentalcore, text messages, peer navigation
Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Text messages; Behavioral: Peer navigation
Experimental Condition 13Experimentalcore, lottery prize, peer navigation
Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Lottery prize for vaccination; Behavioral: Peer navigation
Experimental Condition 14Experimentalcore, SDM, lottery prize, peer navigation
Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making; Behavioral: Lottery prize for vaccination; Behavioral: Peer navigation
Experimental Condition 15Experimentalcore, text messages, lottery, peer navigation
Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Text messages; Behavioral: Lottery prize for vaccination; Behavioral: Peer navigation
Experimental Condition 16Experimentalcore, SDM, text message, lottery, peer navigation
Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making; Behavioral: Text messages; Behavioral: Lottery prize for vaccination; Behavioral: Peer navigation
Experimental Condition 2ExperimentalCore, SDM
Receives: Behavioral: Health education on COVID and flu vaccination; Behavioral: Nurse-led shared decision-making

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vaccination for COVID-19

    Vaccination for COVID-19 with documentary evidence

    Measured: 3- and 6-months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2024
  2. Study start1 Apr 2025 (estimated)
  3. Primary completion1 Apr 2025
  4. Study completion1 Apr 2025

Why it stopped: terminated by NIH

Resources

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 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06614361
Sponsor's protocol ID
IRB-FY2025-9851
Acronym
NCAP2
Status last verified
Mar 2025
First submitted
25 Sep 2024
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Health education on COVID and flu vaccination, Nurse-led shared decision-making and Text messages in people with COVID 19 and Influenza, run by New York University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Vaccination for COVID-19 (time frame: 3- and 6-months post-baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Apr 2025.

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