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Getting to Yes, Michigan! (G2YMI) (G2YMI)

Primary Purpose

COVID-19 Vaccines, COVID-19 Pandemic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing based SMS/MMS and web content
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 Vaccines focused on measuring COVID-19 Vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Live in one of the target Michigan counties of Genesee, Kent, Washtenaw, or Wayne
  • Persons who have had received the COVID-19 vaccine may be a Champion/Champion+ in the intervention
  • Persons who have not received the COVID-19 vaccine can receive the full intervention

Exclusion Criteria:

  • Persons who have received the COVID-19 vaccine cannot participate in the tailored content intervention
  • Persons who have not received the COVID-19 vaccine cannot be a Champion/Champion+ in the intervention
  • Live outside Genesee, Kent, Washtenaw, or Wayne Counties in Michigan
  • Persons under the age of 18

Sites / Locations

  • Michigan MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Self-reported COVID-19 Vaccine uptake
The primary outcome is the binary variable of participant-reported vaccine uptake over the 6 month intervention period. Participants will also be asked which vaccine, how many doses completed, location it was delivered, and date of delivery.

Secondary Outcome Measures

Intention to uptake COVID-19 Vaccine
Vaccine Intentions will be assessed by asking, on a scale of 0-10, "how likely is it that you will get the COVID-19 vaccine?", with 0 being very unlikely and 10 being very likely. This will be analyzed using linear regression as described in the data analysis section.

Full Information

First Posted
October 14, 2021
Last Updated
April 25, 2023
Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05096260
Brief Title
Getting to Yes, Michigan! (G2YMI)
Acronym
G2YMI
Official Title
Community-Centered Interventions for Improved Vaccine Uptake for COVID-19 (CIVIC): Getting to Yes, Michigan! (G2YMI)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
September 5, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Increase understanding of the barriers and drivers of vaccine uptake and hesitancy; 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.
Detailed Description
Like many states across the country, COVID-19 cases and deaths have impacted communities of color in Michigan at disproportionately higher rates than whites. A staggering reality is that while African Americans represent only 13.6% of Michigan's population, they represent 40% of the deaths from COVID-19. Half of the cases and deaths in Michigan occurred in Wayne County. Other Counties in the lower half of Michigan have similar disparities including Genesee, Washtenaw, and Kent. In Genesee County, where African Americans represent 20.3% of the population, they represent 35% of COVID-19 cases and 45% of deaths. In Washtenaw County, nearly half of the cases to date are located in two majority low-income zip codes in the city of Ypsilanti. African American residents, who make up 12% of the Washtenaw population, disproportionately constitute more than a quarter of the cases. And in Kent County, while 10.8% of the population is Latinx, this ethnic group makes up 32.4% of COVID-19 cases. Preliminary data from the state reveal that these disparities will likely worsen due to significant hesitancy, fear, mistrust and misinformation regarding the COVID-19 vaccine if nothing is done to change current trends.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Vaccines, COVID-19 Pandemic
Keywords
COVID-19 Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individually randomized control design: control participants will receive the intervention after completion of the follow-up survey (at six months).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Enrolled study participants receive Motivational Interviewing based SMS/MMS messages to increase COVID-19 vaccine uptake, and complete Baseline and Follow-up surveys.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing based SMS/MMS and web content
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported COVID-19 Vaccine uptake
Description
The primary outcome is the binary variable of participant-reported vaccine uptake over the 6 month intervention period. Participants will also be asked which vaccine, how many doses completed, location it was delivered, and date of delivery.
Time Frame
6 months after the start of the intervention
Secondary Outcome Measure Information:
Title
Intention to uptake COVID-19 Vaccine
Description
Vaccine Intentions will be assessed by asking, on a scale of 0-10, "how likely is it that you will get the COVID-19 vaccine?", with 0 being very unlikely and 10 being very likely. This will be analyzed using linear regression as described in the data analysis section.
Time Frame
change from baseline at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Eligibility inclusion criteria: 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 Exclusion criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ken Resnicow, Ph.D.
Phone
734-904-3888
Email
kresnic@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emerson Delacroix, M.A.C.P.
Phone
7347642014
Email
emmed@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Resnicow, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emerson Delacroix, M.A.C.P.
Organizational Affiliation
University of Michigan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Arthi Ramakrishnan, MS, CCRP
Organizational Affiliation
University of Michigan - Michigan Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Erica Marsh, M.D.
Organizational Affiliation
University of Michigan - Michigan Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Spiroff, M.H.A.
Phone
810-919-9069
Email
mairgood@med.umich.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A deidentified dataset will be made available at the conclusion of the study per funder requirements.
IPD Sharing 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.
IPD Sharing Access Criteria
The study team members will have access to the data and results at the end of the study.

Learn more about this trial

Getting to Yes, Michigan! (G2YMI)

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