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临床试验/NCT05096260
NCT05096260已完成不适用

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

University of Michigan2 个研究点 分布在 1 个国家目标入组 1,180 人开始时间: 2022年7月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,180
试验地点
2
主要终点
Self-reported COVID-19 Vaccine uptake

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Motivational Interviewing based SMS/MMS and web content (Behavioral)

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.

结局指标

主要结局

Self-reported COVID-19 Vaccine uptake

时间窗: 6 months after the start of the intervention

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.

Self-reported COVID-19 Vaccine Uptake

时间窗: 6 months after the start of the intervention

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

次要结局

  • Intention to uptake COVID-19 Vaccine(change from baseline at 6 months)
  • Percent of Participants Not Vaccinated Who Reported HIGH Intention to Uptake COVID-19 Vaccine(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ken Resnicow

Professor, Health Behavior & Health Education

University of Michigan

研究点 (2)

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Getting to Yes, Michigan! (G2YMI) | 临床试验