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COVID-19 Vaccine Hesitancy Among African Americans

2022年4月11日 更新者:Meharry Medical College

Using Multi-strategies to Address COVID-19 Vaccine Hesitancy Among African Americans

Coronavirus disease 2019 (COVID-19) has created a "state of emergency" for African Americans in the US. Recent findings indicate 31% of adults self-reported "wait and see" of the COVID-19 vaccine, of which 16% were African American. This project seeks to test the feasibility and impact of a multi-layered, culturally-appropriate social marketing intervention targeting COVID-19 vaccine hesitant (VH) African Americans to increase vaccine confidence, uptake, and completion of multi-dose vaccine series in Nashville/Davidson County, Tennessee. This study's novelty lies in being the first to assess feasibility and preliminary efficacy of a multi-layered, culturally-appropriate social marketing intervention to promote COVID-19 vaccination among African Americans in TN. Clinical significance is increased vaccine uptake and decreased COVID-19 burden and disparities.

研究概览

地位

邀请报名

详细说明

The goal of this application is to develop and test the feasibility and impact of a multi-layered, culturally-appropriate social marketing intervention targeting COVID-19 VH African Americans to increase uptake and completion of vaccine series in Nashville/Davidson County, Tennessee (TN). Investigators will partner with members of National Association for the Advancement of Colored People, Nashville Health Disparities Coalition, and Congregational Health Education Network to serve as an advisory committee. Investigators will also partner with Meharry Medical College (MMC) clinics and Tennessee Department of Health's (TDH) Immunization Program.

Aim 1. Engage with key stakeholders to develop a multi-layered, culturally-appropriate social marketing intervention targeting African Americans who are COVID-19 VH. Investigators will adapt an existing message library using the Health Belief Model,Theory of Reasoned Action, previous VH research, preliminary data of investigators, and feedback from community partners. Next, investigators will conduct semi-structured interviews with 25-30 VH individuals and 5-10 COVID-19 experts to elicit feedback on draft content. Qualitative data will be collected and analyzed iteratively, informing successive intervention modifications to cover a range of concerns for VH individuals, enhance message relevance, and determine media outlets for dissemination. Next, investigators will pre-test intervention prototypes with 16 COVID-19 VH individuals to make final modifications.

Aim 2a. Conduct a pilot study of the intervention and study protocol to demonstrate feasibility and assess impact. Investigators will conduct a pilot study using an experimental field trial design in three TN counties: Davidson County (1 intervention site) and Shelby and Hamilton Counties (2 control sites). COVID-19 vaccine uptake, primary outcome, assessed using: 1) aggregate data from partner clinics and TN immunization registry (TennIIS) and 2) individual, pre-post data from a marketing firm using random digit dialing (RDD). H1: COVID-19 vaccination rates will be higher for VH African Americans at intervention site compared to control sites. Implementation outcomes are feasibility, fidelity, acceptability, appropriateness, and penetration.

Aim 2b. To retrospectively explore knowledge, attitudes, intentions, and implementation outcomes post-intervention. Investigators will use qualitative methods to identify perceived acceptance of different types of media and webpage along with perceived change in knowledge, attitudes, and intentions from African Americans by degree of VH. Investigators will also explore appropriateness, feasibility, penetration, and fidelity as it relates to the social marketing intervention from 3 providers, 3 community-based organization (CBO) staff, and 2 TDH staff. Participants will be identified using RDD and community partner networks.

研究类型

介入性

注册 (预期的)

300

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Tennessee
      • Nashville、Tennessee、美国、37208
        • Meharry Medical College

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • African American
  • Unvaccinated for COVID-19
  • Vaccine hesitant
  • 18 years and older
  • Speaks English

Exclusion Criteria:

  • Not African American
  • Receipt of COVID-19 vaccination
  • under 18 years of age
  • Does not speak English

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Culturally-appropriate social marketing campaign
Participants will receive a multi-layered, social marketing campaign which is deemed culturally appropriate. This will occur over a 6 month -time period. Rates will be observed at 0, 6, and 12 months.
The intervention will be delivered via multiple strategies- social media (YouTube, Facebook), radio, newspaper, tv ads, community partner networks. Participants receive culturally-tailored message on COVID-19 and the vaccine. The strategies will have a link that will open to a website that is optimized for viewing on a computer or mobile phone which has the look and feel of an app, but without requiring the user to download anything to the phone. On the website, participants will be prompted to select their top concerns from a list. Based on the responses, the top barriers or need will each be mapped to a corresponding educational message, which will be displayed to the user with appropriate images or graphics.
无干预:Control Arm 1
Participants will receive no intervention, only to serve as a control site. Rates will be observed at 0, 6, and 12 months.
无干预:Control Arm 2
Participants will receive no intervention, only to serve as a control site. Rates will be observed at 0, 6, and 12 months.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Recruitment rates
大体时间:6 months
percent enrolled in study
6 months
Retention rates
大体时间:1 year
percent completed baseline survey, percent completed follow-up survey
1 year
data collection processes
大体时间:1 year
percent ascertained COVID 19 vaccine status post-intervention
1 year

次要结果测量

结果测量
措施说明
大体时间
COVID-19 vaccine rates
大体时间:6 months
Number of individuals vaccinated post-intervention
6 months
Attitudes toward COVID-19 vaccine
大体时间:6 months
Change in attitudes toward COVID-19 vaccine
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jennifer C Erves, PhD、Meharry Medical College

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年5月20日

初级完成 (预期的)

2022年9月30日

研究完成 (预期的)

2022年9月30日

研究注册日期

首次提交

2021年3月11日

首先提交符合 QC 标准的

2021年3月15日

首次发布 (实际的)

2021年3月16日

研究记录更新

最后更新发布 (实际的)

2022年4月18日

上次提交的符合 QC 标准的更新

2022年4月11日

最后验证

2022年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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