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临床试验/NCT06085547
NCT06085547已完成不适用

Rural Tailored COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake

Michigan State University2 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2023年5月4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
264
试验地点
2
主要终点
Number (Percentage) of Participants Requested to Participate in Home-based Saliva-based SARS-CoV-2 Antibody Testing.

研究概览

简要总结

This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among individuals residing in rural Northern Michigan. This iteration will consider individuals recruited from rural Northern Michigan and assess individuals' willingness to participate in home-based saliva sample collections.

详细描述

Rural Americans are at higher risk of many severe COVID-19 related health outcomes. These disparities are likely to endure given lower vaccination uptake in many rural communities, and also the continued emergence of SARS-COV-2 variants, even as overall vaccination rates and COVID-19 treatments improve. Better understanding and addressing rural disparities in COVID-19 could be aided by SARS-CoV-2 antibody testing that can measure herd immunity, assess vaccination efficacy and uptake, and perhaps inform re-vaccination strategies. However, implementing antibody testing education and outreach in rural contexts poses unique challenges, including that many rural communities remain skeptical of COVID-19 testing and treatment. Moreover, rural communities are racially and regionally diverse, including predominantly White populations in some rural regions, but largely African American in others. Such diversity highlights that tailoring the use of specific antibody communication strategies to particular rural contexts is critical. Another challenge posed by rural contexts is in implementing biological sample collections, including effectively distributing and receiving biospecimen collection kits and ensuring proper sample collections. Taken together, there is an urgent need to develop and evaluate communication and collection strategies that can better promote SARS-CoV-2 antibody testing in diverse rural contexts. This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among individuals residing in rural Northern Michigan. The central hypothesis is that rural Americans will be receptive to antibody testing when communication is specifically tailored, and when non-invasive home-based salivary collection is used. The rationale is that combining effective rural health communication with home-based salivary testing will reduce skepticism and mistrust, and promote uptake that can lead to better grasping and addressing rural disparities in COVID-19. The clinical trial aims for this study are to 1) develop and compare the effects of tailored rural videos about antibody testing to general antibody education videos on salivary antibody testing attitudes, intentions, and behavior among rural White Americans residing in Michigan, and rural African Americans residing in Arkansas; 2) compare effects of tailored rural videos on activation of medical mistrust among rural White Americans in Michigan and rural African Americans in Arkansas when considering antibody testing; and 3) develop, evaluate, and compare the efficacy and fidelity of a protocol for home-based salivary collection in rural contexts that includes sending, collecting, receiving and successfully assaying for SARS-CoV-2 antibodies using salivary collection kits. In this study iteration, the investigators will consider individuals recruited from rural Northern Michigan and assess individuals' willingness to participate in home-based saliva sample collections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

盲法说明

Participants will be unaware of their assignment to a general versus rural-targeted condition.

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

  • White, 18 or older

排除标准

  • All who do not meet inclusion criteria

研究组 & 干预措施

White Rural: General

Active Comparator

White rural participants receive "general consumption" video information about SARS-CoV-2 antibody testing.

干预措施: General SARS-CoV-2 Communication (Behavioral)

White Rural: Rural-Targeted

Experimental

White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing.

干预措施: Rural-Targeted SARS-CoV-2 Communication (Behavioral)

结局指标

主要结局

Number (Percentage) of Participants Requested to Participate in Home-based Saliva-based SARS-CoV-2 Antibody Testing.

时间窗: Immediately following didactic study portion and health communication randomization on day 1.

Number (percentage) of participants who respond "yes" to be included in the offer to participate in no cost home-based SARS-CoV-2 salivary antibody testing.

Number (Percentage) of Participants Who Completed Home-based Salivary Antibody Testing.

时间窗: 8 weeks from the day of consenting to participate in the home-based salivary-based SARS-CoV-2 antibody testing.

Number (Percentage) of participants that requested to participate in antibody testing who actually complete antibody testing.

Theory of Planned Behavior Antibody Testing Outcomes

时间窗: collected immediately, up to 1 hour

Self-report measures of antibody testing attitudes, norms, perceived control, and intentions to be screened are each adapted from published research (Lucas et al., 2021). These items are constructed following recommended procedures to ensure construct validity and adequate behavioral specificity (Fishbein \& Ajzen, 2011). All items use Likert-type scales that range from 1 (Strongly Agree) to 7 (Strongly Disagree).

Antibody Testing Rural-Adapted Anticipatory Racism

时间窗: Immediately following didactic study portion and health communication randomization on day 1.

Extent to which participants believe that rural racism-related factors would diminish the value of SARS-CoV-2 antibody testing for self (Seven-point Likert rating, with higher scores indicating greater Anticipatory Racism).

次要结局

未报告次要终点

研究者

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

Todd Lucas

C.S. Mott Endowed Professor

Michigan State University

研究点 (2)

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