COVID-19 VaccinesG2YMINCT05096260
Getting to Yes, Michigan! (G2YMI)
A study testing Motivational Interviewing based SMS/MMS and web content in people with COVID-19 Vaccines and COVID-19 Pandemic, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccines, COVID-19 Pandemic
- What is being tested?
- Motivational Interviewing based SMS/MMS and web content
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,180 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community-Centered Interventions for Improved Vaccine Uptake for COVID-19 (CIVIC): 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:
- 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.
Read the 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.
- Conditions
- COVID-19 Vaccines, COVID-19 Pandemic
- Being tested
- Motivational Interviewing based SMS/MMS and web content
- Keywords
- COVID-19 Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing based SMS/MMS and web contentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported COVID-19 Vaccine Uptake
The primary outcome is the binary variable of participant-reported vaccine uptake.
Measured: 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
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start5 Jul 2022
- Primary completion1 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19 VaccinesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Ken Resnicow, University of Michigan
- Investigators
- Ken Resnicow, Ph.D., Principal investigator, University of MichiganEmerson Delacroix, M.A.C.P., Study director, University of MichiganErica Marsh, M.D., Principal investigator, University of Michigan - Michigan Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096260
- Sponsor's protocol ID
- G2YMI
- Other IDs
- 1R01MD016867-01
- Acronym
- G2YMI
- Status last verified
- Apr 2026
- First submitted
- 14 Oct 2021
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A deidentified dataset will be made available at the conclusion of the study per funder requirements.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Centered Interventions for Improved Vaccine Uptake for COVID-19 (CIVIC): Getting to Yes, Michigan! (G2YMI)
- ClinicalTrials.gov ID
- NCT05096260
- Acronym / sponsor ID
- G2YMI / G2YMI
- Conditions
- COVID-19 Vaccines, COVID-19 Pandemic
- Keywords
- COVID-19 Vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,180 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individually randomized control design: control participants will receive the intervention after completion of the follow-up survey (at six months).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Motivational Interviewing based SMS/MMS and web contentEnrolled study participants receive Motivational Interviewing based SMS/MMS messages to increase COVID-19 vaccine uptake, and complete Baseline and Follow-up surveys. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing based SMS/MMS and web contentOur 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. | Behavioural | Intervention |
Primary outcome
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.
1 secondary outcome
Percent of Participants Not Vaccinated Who Reported HIGH Intention to Uptake COVID-19 Vaccine
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. A deidentified dataset will be made available at the conclusion of the study per funder requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Resnicow, Ph.D. principal investigator
University of Michigan
Emerson Delacroix, M.A.C.P. study director
University of Michigan
Erica Marsh, M.D. principal investigator
University of Michigan - Michigan Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing based SMS/MMS and web content in people with COVID-19 Vaccines and COVID-19 Pandemic, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported COVID-19 Vaccine Uptake (time frame: 6 months after the start of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.