Getting to Yes, Michigan! (G2YMI)

NCT05096260 | Completed Results

• 2 other identifiers: G2YMI1R01MD016867-01
• Study Type: interventional
• Target: 1,180
• Locations: 1 country
• Sites: 1

Brief Summary

This study entitled Community-Centered Interventions for Improved Vaccine Uptake for COVID-19 (CIVIC): Getting to Yes, Michigan!, is designed to increase vaccine uptake among populations that experience COVID-19 related disparities. The investigators will focus on the four counties within Michigan where a disproportionate burden of COVID-19 is within African Americans and Latinx communities, i.e., Wayne, Genesee, Kent and Washtenaw Counties. Using a community-based participatory research (CBPR) approach, CIVIC will leverage: its long term relationships with the communities involved, an established CBPR Steering Committee developed and the knowledge gained as a Community Engagement Alliance (CEAL) grant recipient, the resources and networks of the University of Michigan CTSA (MICHR), and the expertise of our academic partners to identify and understand factors that contribute to COVID-19 vaccine hesitancy in African Americans and Latinx communities in Michigan. The investigators will develop and test interventions based on community-centered approaches to achieve a primary goal of increased vaccine uptake. The investigators will achieve this goal with the following aims:

1. 1.Increase understanding of the barriers and drivers of vaccine uptake and hesitancy;
2. 2.Increase vaccine uptake and decrease vaccine hesitancy through the implementation and evaluation of a multi-component intervention; and maintain, enhance, and evaluate the effectiveness of the CIVIC partnership to equitably engage all partners.

Conditions

COVID-19 Vaccines; COVID-19 Pandemic

Keywords

COVID-19 Vaccine

Outcome Measures

Primary Outcomes (1)

• Self-reported COVID-19 Vaccine Uptake

  The primary outcome is the binary variable of participant-reported vaccine uptake.

  6 months after the start of the intervention

Secondary Outcomes (1)

• Percent of Participants Not Vaccinated Who Reported HIGH Intention to Uptake COVID-19 Vaccine

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Enrolled study participants receive Motivational Interviewing based SMS/MMS messages to increase COVID-19 vaccine uptake, and complete Baseline and Follow-up surveys.

Behavioral: Motivational Interviewing based SMS/MMS and web content

Control

NO INTERVENTION

Enrolled study participants receive a simple website and complete a Baseline and Follow-up survey, after which they will receive the interventional Motivational Interviewing based SMS/MMS messages to increase COVID-19 vaccine uptake.

Interventions

Motivational Interviewing based SMS/MMS and web content BEHAVIORAL

Our primary framework that will guide the web content is Self-Determination Theory (SDT). SDT differentiates between autonomous (conscious choice and are personally relevant) and controlled behavioral regulation (performed due to pressure or coercion by external or internal forces). Messages that enhance autonomy and perceived competence and are consistent with a person's values and goals will be more effective in changing behavior than messages focusing on external rewards. To link vaccination to broader values and goals, participants will select 3-4 goals from approximately 20 values/goals. Individually tailored messages will link each of these values to vaccination. We will also tailor testimonials based on member values and communication style preference.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unvaccinated or unboosted adults 18 years and older who are interested in participating in the study OR vaccinated and boosted adults 18 years and older who are interested in becoming a Champion.
• Must be able to read and write in English or Spanish
• Must be able to receive SMS/MMS/text messages

You may not qualify if:

• Persons under the age of 18
• unable to read or write English or Spanish
• unable or unwilling to receive SMS/MMS
• unwilling to consent
• for vaccine champions-unwillingness to complete communication trainings in English
• No specific racial, ethnic, nor sex/gender group is excluded.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Ken Resnicow
• Organization: University of Michigan

kresnic@umich.edu

(734) 904-3888

Study Officials

• Ken Resnicow, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Emerson Delacroix, M.A.C.P.

  University of Michigan

  STUDY DIRECTOR

• Erica Marsh, M.D.

  University of Michigan - Michigan Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Health Behavior & Health Education

Model Details: Individually randomized control design: control participants will receive the intervention after completion of the follow-up survey (at six months).

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 27, 2021
• Study Start: July 5, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 30, 2025
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The study team at the University of Michigan will disseminate the protocol with any deviations or adverse events to the UM-IRB. Data will be de-identified after the intervention phase ends which is planned for May 2024.
• Access Criteria: The study team members will have access to the data and results at the end of the study.

Locations

US (1)