Recruiting

Vaccine Promotion

Sponsor:

Northeastern University

Code:

NCT04884750

Conditions

Pandemics

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ECA-ACE Vaccination Promotion Intervention

Study Details

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.

Conditions

Pandemics

Study ID

NCT04884750

Start date

Dec 12, 2022

Status verified date

Dec, 2023

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: High engagement mechanisms, tailed content

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.

experimental: Low engagement mechanisms, tailed content

manipulate low engagement mechanisms while provide adaptive religiosity (tailored) content

experimental: High engagement mechanism, non-tailed content

manipulate high engagement mechanisms while provide secular (non-tailored) content

experimental: Low engagement mechanism, non-tailed content

manipulate low engagement mechanisms and provide secular (non-tailored) content

Interventions

ECA-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.

Primary outcome measure

  • Change of SARS-CoV-2 vaccination status [ Time Frame: baseline, 6months, 12months ]
  • Change of Influenza vaccination status Influenza vaccination status [ Time Frame: baseline, 6months, 12months ]

Central Contacts and Locations

Central contacts

Locations

Northeastern University

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

More Information

Sponsor

Northeastern University

Last update posted

Dec 22, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northeastern University on 2023-12-22.