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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD016867-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Eligibility inclusion criteria:
Exclusion criteria:
No specific racial, ethnic, nor sex/gender group is excluded.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Medicine | Ann Arbor | Michigan | 48109 | United States |
A deidentified dataset will be made available at the conclusion of the study per funder requirements.
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.
The study team members will have access to the data and results at the end of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Enrolled study participants receive Motivational Interviewing based SMS/MMS messages to increase COVID-19 vaccine uptake, and complete Baseline and Follow-up surveys. |
| FG001 | Control | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants could choose not to disclose demographics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Enrolled study participants receive Motivational Interviewing based SMS/MMS messages to increase COVID-19 vaccine uptake, and complete Baseline and Follow-up surveys. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean Age. | Participants could choose not to disclose. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self-reported COVID-19 Vaccine Uptake | The primary outcome is the binary variable of participant-reported vaccine uptake. | We've added the number of participants analyzed. | Posted | Count of Participants | Participants | 6 months after the start of the intervention |
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Enrollment to 6-month follow-up
Any unfavorable sign, symptom, or occurrence (physical, psychological, or social) temporally linked to study participation, even if not caused by the intervention.
Adverse events were not collected during Period 2
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Enrolled study participants receive Motivational Interviewing based SMS/MMS messages to increase COVID-19 vaccine uptake, and complete Baseline and Follow-up surveys. NOT REPORTED DURING OPEN LABEL PERIOD. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ken Resnicow | University of Michigan | (734) 904-3888 | kresnic@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 26, 2024 | Apr 28, 2026 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2022 | Apr 28, 2026 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 24, 2023 | Apr 28, 2026 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Individually randomized control design: control participants will receive the intervention after completion of the follow-up survey (at six months).
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| 6 months |
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.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex/Gender, Customized | Gender was analyzed in three categories. | Participants could chose not to disclose. | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Participants were either African American or Black, and/or Latino/a. | Participants could choose not to disclose. | Count of Participants | Participants | No |
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| Secondary | 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 | We corrected the sample size for the secondary outcome of intention | Posted | Count of Participants | Participants | 6 months |
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|
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|
| 0 |
| 696 |
| 0 |
| 696 |
| 0 |
| 696 |
| EG001 | Control | 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. NOT REPORTED DURING OPEN LABEL PERIOD. | 0 | 484 | 0 | 484 | 0 | 484 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |