Conversational Agent Vaccine Promotion RCT
Community-based Design and Evaluation of A Conversational Agent to Promote SARS-COV2 Vaccination in Black Churches
1 other identifier
interventional
600
1 country
1
Brief Summary
The objective of this study is to assess the use of and satisfaction with the ECA intervention over a 12-month period, its ability to increase SARS-CoV-2 and influenza vaccination in the BMATP community, and the comparative effectiveness of proactive engagement strategies and cultural tailoring on these factors. The Investigators will assess app use and satisfaction among these participants, along with self-reported vaccination attitudes and behavior, at 6 months and 12 months. During this time the investigators will conduct a 2x2 factorial RCT (with the individual the unit of random assignment and measurement) to assess the impact of two app design features on engagement and outcomes: (1) the investigators will manipulate engagement mechanisms (ENGAGEMENT), including reminder notifications and trust-building dialogue by the ECA and, (2) independently manipulate cultural tailoring of vaccination promotion counseling language used by the agent (TAILORING) to either adaptive religiosity (tailored) or secular (non-tailored). The investigators' primary hypotheses are that participants with have significantly greater vaccination completion rates in the high engagement and tailored conditions at 6 months (H1) and 12 months (H2) compared to other conditions. The investigators' secondary hypotheses are that participants will use the app more, be more satisfied with the ECA, be more advanced in their stage of change, and have greater knowledge, self-efficacy, and decisional-balance from baseline to 6 and 12 months, in the high engagement and tailored conditions. In addition to the RCT participants, all members of the 12 participating BMATP churches will be invited to use the app (via snowball recruitment), to increase the utility of the social networking functions of the app by having as many users as possible.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2021
CompletedFirst Posted
Study publicly available on registry
May 13, 2021
CompletedStudy Start
First participant enrolled
December 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedDecember 22, 2023
December 1, 2023
2.6 years
May 5, 2021
December 21, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Change of SARS-CoV-2 vaccination status
Vaccination completion will be assessed via self-report by asking whether participants are up-to-date with Boston Public Health Commission vaccination guidelines (yes or no) for SARS-CoV-2
baseline, 6months, 12months
Change of Influenza vaccination status Influenza vaccination status
Vaccination completion will be assessed via self-report by asking whether participants are up-to-date with Boston Public Health Commission vaccination guidelines (yes or no) for Influenza
baseline, 6months, 12months
Secondary Outcomes (5)
Change of Satisfaction Status
6 months, 12 months
Stage of Change for Vaccination
baseline,6months,12months
Self-Efficacy for Vaccination
baseline,6months,12months
Decisional Balance for Vaccination
baseline,6months,12months
Knowledge
baseline,6months,12months
Study Arms (4)
High engagement mechanisms, tailed content
EXPERIMENTALDuring this time the investigators will conduct a 2x2 factorial RCT (with the individual the unit of random assignment and measurement) to assess the impact of two app design features on engagement and outcomes: (1) the investigators will manipulate engagement mechanisms (ENGAGEMENT), including reminder notifications and trust-building dialogue by the ECA and, (2) independently manipulate cultural tailoring of vaccination promotion counseling language used by the agent (TAILORING) to either adaptive religiosity (tailored) or secular (non-tailored). The investigators' primary hypotheses are that participants with have significantly greater vaccination completion rates in the high engagement and tailored conditions at 6 months (H1) and 12 months (H2) compared to other conditions.
Low engagement mechanisms, tailed content
EXPERIMENTALmanipulate low engagement mechanisms while provide adaptive religiosity (tailored) content
High engagement mechanism, non-tailed content
EXPERIMENTALmanipulate high engagement mechanisms while provide secular (non-tailored) content
Low engagement mechanism, non-tailed content
EXPERIMENTALmanipulate low engagement mechanisms and provide secular (non-tailored) content
Interventions
A smartphone-based embodied conversational agent that educates users and motivates them to obtain vaccinations for SARS-CoV-2 and Influenza, according to Boston Public Health Commission guidelines.
Eligibility Criteria
You may qualify if:
- over 18 years old;
- speaks English fluently;
- is able to independently consent;
- has adequate corrected vision to use the ECA system (based on a 1 minute ECA functional screener deployed over the web);
- has adequate hearing to use the ECA system;
- owns a recent model iPhone or Android smartphone.
- do not meet current Boston Public Health commission guidelines for SARS-CoV-2 vaccination OR do not meet current Boston Public Health commission guidelines for Influenza vaccination.
You may not qualify if:
- they are not able demonstrate comprehension of the research study;
- they are unable to use the screener
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northeastern Universitylead
- Boston Universitycollaborator
- Boston Medical Centercollaborator
- Georgia Institute of Technologycollaborator
Study Sites (1)
Northeastern University
Boston, Massachusetts, 02115, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2021
First Posted
May 13, 2021
Study Start
December 12, 2022
Primary Completion
June 30, 2025
Study Completion
December 1, 2025
Last Updated
December 22, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
The dissemination plan has two overall goals: 1. Scientific Dissemination of Study Findings For our scientific stakeholders, the investigators will publish findings in the peer-reviewed scientific literature, and also present findings at scientific conferences and through invited seminars to share these findings. In addition, the investigators plan to make data available for collaborative analyses with colleagues around the world. 2. Community Dissemination of Intervention In the final two years of the effort, intervention materials will be revised based on feedback and lessons learned from the RCTs. The smartphone app will be opened so that anyone can download and use it, and extended to automatically collect basic sociodemographics, primary outcome measures, and usage directly from users if they electronically consent upon initiation of the app and saved to the central database, so that dissemination, use, and outcomes can be tracked and evaluated during dissemination.