Clinical trial NCT04884750: Conversational Agent Vaccine Promotion RCT
Official title: Community-based Design and Evaluation of A Conversational Agent to Promote SARS-COV2 Vaccination in Black Churches
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pandemics
Lead sponsor: Northeastern University
Sponsor class: OTHER
Collaborators: name: Boston University
name: Boston Medical Center
name: Georgia Institute of Technology
First posted: 2021-05-13
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of SARS-CoV-2 vaccination status
timeFrame: baseline, 6months, 12months
measure: Change of Influenza vaccination status Influenza vaccination status
timeFrame: baseline, 6months, 12months
Secondary outcomes:
measure: Change of Satisfaction Status
timeFrame: 6 months, 12 months
measure: Stage of Change for Vaccination
timeFrame: baseline,6months,12months
measure: Self-Efficacy for Vaccination
timeFrame: baseline,6months,12months
measure: Decisional Balance for Vaccination
timeFrame: baseline,6months,12months
measure: Knowledge
timeFrame: baseline,6months,12months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
Study officials:
References: