Study Stopped
terminated by NIH
Community-based Behavioral Intervention to Increase Vaccination Using MOST
NCAP2
1 other identifier
interventional
N/A
0 countries
N/A
Brief 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. 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.
Trial Health
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Started Apr 2025
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2024
CompletedFirst Posted
Study publicly available on registry
September 26, 2024
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedApril 29, 2025
March 1, 2025
Same day
September 25, 2024
April 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vaccination for COVID-19
Vaccination for COVID-19 with documentary evidence
3- and 6-months post-baseline
Study Arms (16)
Experimental Condition 1
EXPERIMENTALCore session
Experimental Condition 12
EXPERIMENTALCore session, nurse-led SDM
Experimental Condition 3
EXPERIMENTALCore session, Text messages
Experimental Condition 4
EXPERIMENTALCore session, nurse-led SDM, text messages
Experimental Condition 5
EXPERIMENTALCore, lottery prize
Experimental Condition 6
EXPERIMENTALCore session, nurse-led SDM, lottery prize
Experimental Condition 7
EXPERIMENTALCore, text messages, lottery prize
Experimental Condition 8
EXPERIMENTALCore, nurse-led SDM, text messages, lottery prize
Experimental Condition 9
EXPERIMENTALCore, peer navigation
Experimental Condition 10
EXPERIMENTALCore, nurse-led SDM, peer navigation
Experimental Condition 11
EXPERIMENTALcore, text messages, peer navigation
Experimental Condition 13
EXPERIMENTALcore, lottery prize, peer navigation
Experimental Condition 14
EXPERIMENTALcore, SDM, lottery prize, peer navigation
Experimental Condition 15
EXPERIMENTALcore, text messages, lottery, peer navigation
Experimental Condition 16
EXPERIMENTALcore, SDM, text message, lottery, peer navigation
Experimental Condition 2
EXPERIMENTALCore, SDM
Interventions
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
Peer navigation (4 months duration, contact as needed).
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- New York Universitylead
- Northern Manhattan Improvement Corporationcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2024
First Posted
September 26, 2024
Study Start
April 1, 2025
Primary Completion
April 1, 2025
Study Completion
April 1, 2025
Last Updated
April 29, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share