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Completed

NCT Number: NCT05096260

Getting to Yes, Michigan! (G2YMI)

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. Increase understanding of the barriers and drivers of vaccine uptake and hesitancy; 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.

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Key information

Conditions

COVID-19 Vaccines COVID-19 COVID-19 Pandemic Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Self-reported COVID-19 Vaccine Uptake

    Time frame: 6 months after the start of the intervention

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

Secondary outcomes

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

    Time frame: 6 months

    Intention to vaccinate was assessed with a single item, 'How are you currently feeling about getting the updated COVID-19 vaccine? Would you…' with the following response options: 1. Definitely get it, 2. Probably get it, 3. Probably not get it, and 4. Definitely not get it. Responses 1 and 2 were collapsed into 'High intention to vaccinate' and responses 3 and 4 were collapsed into 'Low intention to vaccinate'. The data table shows the number of participants with high intention to vaccinate. Please note we only report this outcome for those NOT reporting vaccination at 6 months

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

Community-Centered Interventions for Improved Vaccine Uptake for COVID-19 (CIVIC): Getting to Yes, Michigan! (G2YMI)

Acronym: G2YMI

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 27, 2021
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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