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Conversational Agent Vaccine Promotion RCT

Community-based Design and Evaluation of A Conversational Agent to Promote SARS-COV2 Vaccination in Black Churches

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04884750
Enrollment
600
Registered
2021-05-13
Start date
2022-12-12
Completion date
2025-12-01
Last updated
2023-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pandemics

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.

Detailed description

4.1.a.1. Randomization. Study participants will be randomized into one of the four study conditions (ENGAGEMENT x TAILORING) using blocked randomization with randomly permuted block sizes of 2 and 4, by software on the central server referenced when participants first activate the app on their phone. Participants will continue using the app at home, and will be called at 6 months and 12 months to assess outcome measures during a videoconference call with a research assistant. 4.1.a.2. Qualitative Interviews. The investigators will conduct interviews with a sample of participants completing the study (12), as well as with Church and Health Ministry leadership (12) to understand overall acceptance of ECA-ACE and barriers to deployment and use. 4.1.a.3. Qualitative Methods for all Project Focus Groups and Interviews. Videoconference-based focus groups and interviews will be facilitated using a semi-structured interview guide, audio-recorded, and transcribed verbatim by a professional transcription service. The investigators will conduct a thematic analysis of these transcripts guided by the investigators' research questions with the aim of identifying design insights. The investigators will use grounded theory analysis, including constant comparisons, axial and selective coding, and memo writing. Using NVivo 12.5.0 software, two researchers will inductively code transcripts separately, labeling emergent phenomena in the data to arrive at a codebook. Two researchers will then independently apply the codebook to participant transcripts, meeting regularly to discuss discrepancies in the applications of the codes, updates to the codebook, and contradictory data. Sample sizes specified should be adequate to reach thematic saturation relative to the investigators' research questions.

Interventions

BEHAVIORALECA-ACE Vaccination Promotion Intervention

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.

Sponsors

Boston University
CollaboratorOTHER
Boston Medical Center
CollaboratorOTHER
Georgia Institute of Technology
CollaboratorOTHER
Northeastern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. over 18 years old; 2. speaks English fluently; 3. is able to independently consent; 4. has adequate corrected vision to use the ECA system (based on a 1 minute ECA functional screener deployed over the web); 5. has adequate hearing to use the ECA system; 6. owns a recent model iPhone or Android smartphone. 7. 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.

Exclusion criteria

1. they are not able demonstrate comprehension of the research study; 2. they are unable to use the screener

Design outcomes

Primary

MeasureTime frameDescription
Change of SARS-CoV-2 vaccination statusbaseline, 6months, 12monthsVaccination 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
Change of Influenza vaccination status Influenza vaccination statusbaseline, 6months, 12monthsVaccination 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

Secondary

MeasureTime frameDescription
Stage of Change for Vaccinationbaseline,6months,12monthsSelf report of Precontemplation, Contemplation, Preparation, or Action/Maintenance for vaccination
Decisional Balance for Vaccinationbaseline,6months,12monthsSelf report of Pros and Cons of vaccination
Change of Satisfaction Status6 months, 12 monthsSelf report System Usability Scale (self report), plus system use from log file analysis.
Self-Efficacy for Vaccinationbaseline,6months,12monthsSelf report of confidence in ability to get vaccinated in light of barriers
Knowledgebaseline,6months,12monthsKnowledge of COVID-19 and Influenza assessed via 10-item true/false knowledge tests.

Countries

United States

Contacts

Primary ContactMadison Blain, OTD
m.blain@northeastern.edu(617) 858-6727‬
Backup ContactTimothy W Bickmore, PhD
t.bickmore@northeastern.edu617-373-5477

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026