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Community-based Behavioral Intervention to Increase Vaccination Using MOST

NCT ID: NCT06614361

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-04-01

Brief Summary

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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.

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Detailed Description

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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

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COVID 19 Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental Condition 1

Core session

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Experimental Condition 12

Core session, nurse-led SDM

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Nurse-led shared decision-making

Intervention Type BEHAVIORAL

1 session and FU calls with a trained nurse

Text messages

Intervention Type BEHAVIORAL

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

Peer navigation

Intervention Type BEHAVIORAL

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

Experimental Condition 3

Core session, Text messages

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Text messages

Intervention Type BEHAVIORAL

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

Experimental Condition 4

Core session, nurse-led SDM, text messages

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Nurse-led shared decision-making

Intervention Type BEHAVIORAL

1 session and FU calls with a trained nurse

Text messages

Intervention Type BEHAVIORAL

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

Experimental Condition 5

Core, lottery prize

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Lottery prize for vaccination

Intervention Type BEHAVIORAL

Modest lottery prize for COVID vaccination

Experimental Condition 6

Core session, nurse-led SDM, lottery prize

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Nurse-led shared decision-making

Intervention Type BEHAVIORAL

1 session and FU calls with a trained nurse

Lottery prize for vaccination

Intervention Type BEHAVIORAL

Modest lottery prize for COVID vaccination

Experimental Condition 7

Core, text messages, lottery prize

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Text messages

Intervention Type BEHAVIORAL

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

Lottery prize for vaccination

Intervention Type BEHAVIORAL

Modest lottery prize for COVID vaccination

Experimental Condition 8

Core, nurse-led SDM, text messages, lottery prize

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Nurse-led shared decision-making

Intervention Type BEHAVIORAL

1 session and FU calls with a trained nurse

Text messages

Intervention Type BEHAVIORAL

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

Lottery prize for vaccination

Intervention Type BEHAVIORAL

Modest lottery prize for COVID vaccination

Experimental Condition 9

Core, peer navigation

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Peer navigation

Intervention Type BEHAVIORAL

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

Experimental Condition 10

Core, nurse-led SDM, peer navigation

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Nurse-led shared decision-making

Intervention Type BEHAVIORAL

1 session and FU calls with a trained nurse

Peer navigation

Intervention Type BEHAVIORAL

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

Experimental Condition 11

core, text messages, peer navigation

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Text messages

Intervention Type BEHAVIORAL

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

Peer navigation

Intervention Type BEHAVIORAL

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

Experimental Condition 13

core, lottery prize, peer navigation

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Lottery prize for vaccination

Intervention Type BEHAVIORAL

Modest lottery prize for COVID vaccination

Peer navigation

Intervention Type BEHAVIORAL

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

Experimental Condition 14

core, SDM, lottery prize, peer navigation

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Nurse-led shared decision-making

Intervention Type BEHAVIORAL

1 session and FU calls with a trained nurse

Lottery prize for vaccination

Intervention Type BEHAVIORAL

Modest lottery prize for COVID vaccination

Peer navigation

Intervention Type BEHAVIORAL

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

Experimental Condition 15

core, text messages, lottery, peer navigation

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Text messages

Intervention Type BEHAVIORAL

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

Lottery prize for vaccination

Intervention Type BEHAVIORAL

Modest lottery prize for COVID vaccination

Peer navigation

Intervention Type BEHAVIORAL

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

Experimental Condition 16

core, SDM, text message, lottery, peer navigation

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Nurse-led shared decision-making

Intervention Type BEHAVIORAL

1 session and FU calls with a trained nurse

Text messages

Intervention Type BEHAVIORAL

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

Lottery prize for vaccination

Intervention Type BEHAVIORAL

Modest lottery prize for COVID vaccination

Peer navigation

Intervention Type BEHAVIORAL

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

Experimental Condition 2

Core, SDM

Group Type EXPERIMENTAL

Health education on COVID and flu vaccination

Intervention Type BEHAVIORAL

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

Nurse-led shared decision-making

Intervention Type BEHAVIORAL

1 session and FU calls with a trained nurse

Interventions

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Health education on COVID and flu vaccination

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

Intervention Type BEHAVIORAL

Nurse-led shared decision-making

1 session and FU calls with a trained nurse

Intervention Type BEHAVIORAL

Text messages

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

Intervention Type BEHAVIORAL

Lottery prize for vaccination

Modest lottery prize for COVID vaccination

Intervention Type BEHAVIORAL

Peer navigation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern Manhattan Improvement Corporation

UNKNOWN

Sponsor Role collaborator

New York University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB-FY2025-9851

Identifier Type: -

Identifier Source: org_study_id

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