PandemicsNCT04884750
Conversational Agent Vaccine Promotion RCT
A study testing ECA-ACE Vaccination Promotion Intervention in people with Pandemics, run by Northeastern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pandemics
- What is being tested?
- ECA-ACE Vaccination Promotion Intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- they are not able demonstrate comprehension of the research study;
- they are unable to use the screener
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Northeastern University
Boston, Massachusetts, 02115
Madison Blain, OTD, 6178586727, m.blain@northeastern.edu
About this study
Official title: Community-based Design and Evaluation of A Conversational Agent to Promote SARS-COV2 Vaccination in Black Churches
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.
Read the 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.
- Conditions
- Pandemics
- Being tested
- ECA-ACE Vaccination Promotion Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECA-ACE Vaccination Promotion InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High engagement mechanisms, tailed content | Experimental | 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. Receives: Behavioral: ECA-ACE Vaccination Promotion Intervention |
| Low engagement mechanisms, tailed content | Experimental | manipulate low engagement mechanisms while provide adaptive religiosity (tailored) content Receives: Behavioral: ECA-ACE Vaccination Promotion Intervention |
| High engagement mechanism, non-tailed content | Experimental | manipulate high engagement mechanisms while provide secular (non-tailored) content Receives: Behavioral: ECA-ACE Vaccination Promotion Intervention |
| Low engagement mechanism, non-tailed content | Experimental | manipulate low engagement mechanisms and provide secular (non-tailored) content Receives: Behavioral: ECA-ACE Vaccination Promotion Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline, 6months, 12months
Secondary outcomes (5)
Change of Satisfaction Status
Self report System Usability Scale (self report), plus system use from log file analysis.
Measured: 6 months, 12 months
Stage of Change for Vaccination
Self report of Precontemplation, Contemplation, Preparation, or Action/Maintenance for vaccination
Measured: baseline,6months,12months
Self-Efficacy for Vaccination
Self report of confidence in ability to get vaccinated in light of barriers
Measured: baseline,6months,12months
Decisional Balance for Vaccination
Self report of Pros and Cons of vaccination
Measured: baseline,6months,12months
Knowledge
Knowledge of COVID-19 and Influenza assessed via 10-item true/false knowledge tests.
Measured: baseline,6months,12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start12 Dec 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PandemicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, Boston Medical Center, Georgia Institute of Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884750
- Sponsor's protocol ID
- IRB#18-07-02
- Status last verified
- Dec 2023
- First submitted
- 5 May 2021
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Design and Evaluation of A Conversational Agent to Promote SARS-COV2 Vaccination in Black Churches
- ClinicalTrials.gov ID
- NCT04884750
- Acronym / sponsor ID
- IRB#18-07-02
- Conditions
- Pandemics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- Boston University, Boston Medical Center, Georgia Institute of Technology
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High engagement mechanisms, tailed content | Experimental | Behavioral: ECA-ACE Vaccination Promotion InterventionDuring 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 | Experimental | Behavioral: ECA-ACE Vaccination Promotion Interventionmanipulate low engagement mechanisms while provide adaptive religiosity (tailored) content |
| High engagement mechanism, non-tailed content | Experimental | Behavioral: ECA-ACE Vaccination Promotion Interventionmanipulate high engagement mechanisms while provide secular (non-tailored) content |
| Low engagement mechanism, non-tailed content | Experimental | Behavioral: ECA-ACE Vaccination Promotion Interventionmanipulate low engagement mechanisms and provide secular (non-tailored) content |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (2 listed)
- they are not able demonstrate comprehension of the research study;
- they are unable to use the screener
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECA-ACE Vaccination Promotion InterventionA 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. | Behavioural | High engagement mechanism, non-tailed content, High engagement mechanisms, tailed content, Low engagement mechanism, non-tailed content, Low engagement mechanisms, tailed content |
Primary outcome
Change of SARS-CoV-2 vaccination status
Time frame: baseline, 6months, 12months
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
Change of Influenza vaccination status Influenza vaccination status
Time frame: baseline, 6months, 12months
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
5 secondary outcomes
Change of Satisfaction Status
Time frame: 6 months, 12 months
Stage of Change for Vaccination
Time frame: baseline,6months,12months
Self-Efficacy for Vaccination
Time frame: baseline,6months,12months
Decisional Balance for Vaccination
Time frame: baseline,6months,12months
Knowledge
Time frame: baseline,6months,12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECA-ACE Vaccination Promotion Intervention in people with Pandemics, run by Northeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Madison Blain, OTD ((617) 858-6727, m.blain@northeastern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of SARS-CoV-2 vaccination status (time frame: baseline, 6months, 12months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.