Clinical trial NCT05096260: Getting to Yes, Michigan! (G2YMI)
Official title: Community-Centered Interventions for Improved Vaccine Uptake for COVID-19 (CIVIC): Getting to Yes, Michigan! (G2YMI)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COVID-19 Vaccines
COVID-19 Pandemic
Keywords: COVID-19 Vaccine
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2021-10-27
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individually randomized control design: control participants will receive the intervention after completion of the follow-up survey (at six months).
Primary purpose: PREVENTION

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. 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.

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.

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.

Primary outcomes:
measure: Self-reported COVID-19 Vaccine uptake
timeFrame: 6 months after the start of the intervention
Secondary outcomes:
measure: Intention to uptake COVID-19 Vaccine
timeFrame: change from baseline at 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ken Resnicow, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Emerson Delacroix, M.A.C.P.
role: STUDY_DIRECTOR
affiliation: University of Michigan - Michigan Medicine
name: Erica Marsh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: