Community-based Behavioral Intervention to Increase Vaccination Using MOST (NCAP2)
April 23, 2025 updated by: New York University
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.
Study Overview
Status
Withdrawn
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.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria: 2) can engage in study activities in English or Spanish; 3) Black or African American or Latino/Hispanic race/ethnicity; 4) resides in New York City; 5) has received at least one dose of a COVID-19 vaccination in their lifetime but is not up-to-date on COVID-19 vaccination, defined as has not received the most recently available vaccine, confirmed with documentary evidence; 6) eligible to receive the COVID-19 vaccine (has not had anaphylaxis, myocarditis, pericarditis, or thrombosis with thrombocytopenia syndrome or other adverse effects deemed by a physician to be related to the COVID-19 vaccine) and if previously diagnosed with COVID-19, a minimum of 10 days has elapsed since last test positivity; 7) is not up-to-date on influenza vaccination defined as not yet receiving the available influenza vaccine; 8) has a phone that can be used for study participation and can receive text messages.
-
Exclusion Criteria: NONE
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Condition 1
Core session
|
1 session (30 min) with a health educator on vaccination
|
|
Experimental: Experimental Condition 12
Core session, nurse-led SDM
|
1 session (30 min) with a health educator on vaccination
1 session and FU calls with a trained nurse
Health & wellness interactive text message (TM) intervention (12 weeks, 2 texts/week)
Peer navigation (4 months duration, contact as needed).
|
|
Experimental: Experimental Condition 3
Core session, Text messages
|
1 session (30 min) with a health educator on vaccination
Health & wellness interactive text message (TM) intervention (12 weeks, 2 texts/week)
|
|
Experimental: Experimental Condition 4
Core session, nurse-led SDM, text messages
|
1 session (30 min) with a health educator on vaccination
1 session and FU calls with a trained nurse
Health & wellness interactive text message (TM) intervention (12 weeks, 2 texts/week)
|
|
Experimental: Experimental Condition 5
Core, lottery prize
|
1 session (30 min) with a health educator on vaccination
Modest lottery prize for COVID vaccination
|
|
Experimental: Experimental Condition 6
Core session, nurse-led SDM, lottery prize
|
1 session (30 min) with a health educator on vaccination
1 session and FU calls with a trained nurse
Modest lottery prize for COVID vaccination
|
|
Experimental: Experimental Condition 7
Core, text messages, lottery prize
|
1 session (30 min) with a health educator on vaccination
Health & wellness interactive text message (TM) intervention (12 weeks, 2 texts/week)
Modest lottery prize for COVID vaccination
|
|
Experimental: Experimental Condition 8
Core, nurse-led SDM, text messages, lottery prize
|
1 session (30 min) with a health educator on vaccination
1 session and FU calls with a trained nurse
Health & wellness interactive text message (TM) intervention (12 weeks, 2 texts/week)
Modest lottery prize for COVID vaccination
|
|
Experimental: Experimental Condition 9
Core, peer navigation
|
1 session (30 min) with a health educator on vaccination
Peer navigation (4 months duration, contact as needed).
|
|
Experimental: Experimental Condition 10
Core, nurse-led SDM, peer navigation
|
1 session (30 min) with a health educator on vaccination
1 session and FU calls with a trained nurse
Peer navigation (4 months duration, contact as needed).
|
|
Experimental: Experimental Condition 11
core, text messages, peer navigation
|
1 session (30 min) with a health educator on vaccination
Health & wellness interactive text message (TM) intervention (12 weeks, 2 texts/week)
Peer navigation (4 months duration, contact as needed).
|
|
Experimental: Experimental Condition 13
core, lottery prize, peer navigation
|
1 session (30 min) with a health educator on vaccination
Peer navigation (4 months duration, contact as needed).
Modest lottery prize for COVID vaccination
|
|
Experimental: Experimental Condition 14
core, SDM, lottery prize, peer navigation
|
1 session (30 min) with a health educator on vaccination
1 session and FU calls with a trained nurse
Peer navigation (4 months duration, contact as needed).
Modest lottery prize for COVID vaccination
|
|
Experimental: Experimental Condition 15
core, text messages, lottery, peer navigation
|
1 session (30 min) with a health educator on vaccination
Health & wellness interactive text message (TM) intervention (12 weeks, 2 texts/week)
Peer navigation (4 months duration, contact as needed).
Modest lottery prize for COVID vaccination
|
|
Experimental: Experimental Condition 16
core, SDM, text message, lottery, peer navigation
|
1 session (30 min) with a health educator on vaccination
1 session and FU calls with a trained nurse
Health & wellness interactive text message (TM) intervention (12 weeks, 2 texts/week)
Peer navigation (4 months duration, contact as needed).
Modest lottery prize for COVID vaccination
|
|
Experimental: Experimental Condition 2
Core, SDM
|
1 session (30 min) with a health educator on vaccination
1 session and FU calls with a trained nurse
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vaccination for COVID-19
Time Frame: 3- and 6-months post-baseline
|
Vaccination for COVID-19 with documentary evidence
|
3- and 6-months post-baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2025
Primary Completion (Actual)
April 1, 2025
Study Completion (Actual)
April 1, 2025
Study Registration Dates
First Submitted
September 25, 2024
First Submitted That Met QC Criteria
September 25, 2024
First Posted (Actual)
September 26, 2024
Study Record Updates
Last Update Posted (Actual)
April 29, 2025
Last Update Submitted That Met QC Criteria
April 23, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-FY2025-9851
- R01MD019686 (Other Identifier: NIMHD)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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