一项针对农村美国原住民和拉丁裔社区的基于家庭的 COVID-19 检测的实用随机试验：“保护我们的社区”研究方案。

A pragmatic randomized trial of home-based testing for COVID-19 in rural Native American and Latino communities: Protocol for the "Protecting our Communities" study.

机构信息

Institute of Translational Health Sciences, University of Washington, 850 Republican Street, Box 358051, Seattle, WA 98109, USA; Department of Family Medicine, University of Washington, Box 354696, Seattle, WA 98195, USA.

Department of Global Health, University of Washington, Box 351620, Seattle, WA 98195, USA; Department of Medicine, University of Washington, Box 356420, Seattle, WA 98195, USA; Department of Epidemiology, University of Washington, Box 351619, Seattle, WA 98195, USA.

出版信息

Contemp Clin Trials. 2022 Aug;119:106820. doi: 10.1016/j.cct.2022.106820. Epub 2022 Jun 9.

DOI:10.1016/j.cct.2022.106820

PMID:35691487

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9181367/

Abstract

BACKGROUND

Home-based testing for COVID-19 has potential to reduce existing health care disparities among underserved populations in the United States. However, implementation of home-based tests in these communities may face significant barriers. This study evaluates the acceptability, feasibility, and success of home-based testing and the potential added benefit of active support from trusted community health workers for Native Americans and Hispanic/Latino adults living in rural Montana and Washington states.

METHODS/DESIGN: The academic-community research team designed the trial to be responsive to community needs for understanding barriers and supports to home-based COVID-19 testing. The "Protecting Our Community" study is a two-arm pragmatic randomized controlled trial in which a total of 400 participants are randomized to active or passive arms. Participants of both study arms receive a commercially available home collection COVID-19 test kit, which is completed by mailing a self-collected nasal swab to a central laboratory. The primary study outcome is return of the kit to the central lab within 14 days. The cultural, social, behavioral, and economic barriers to home-based COVID-19 testing are also assessed by qualitative research methods. A survey and semi-structured interviews are conducted after the trial to evaluate perceptions and experience of home-based testing.

DISCUSSION

Implementing home-based testing in underserved populations, including among Native American and Hispanic/Latino communities, may require additional support to be successful. The Protecting Our Community trial examines the effect of trusted community health workers on use of home-based testing, which may be adaptable for community-driven models of home-based testing in other underserved populations.

摘要

背景

家庭新冠病毒检测在美国服务欠缺人群中具有减少现有医疗保健差距的潜力。然而，在这些社区实施家庭检测可能面临重大障碍。本研究评估了家庭检测的可接受性、可行性和成功率，以及为居住在蒙大拿州和华盛顿州农村地区的美洲原住民和西班牙裔/拉丁裔成年人提供可信社区卫生工作者的积极支持的潜在额外益处。

方法/设计：学术-社区研究团队设计了这项试验，以满足社区对了解家庭新冠病毒检测障碍和支持的需求。“保护我们的社区”研究是一项两臂实用随机对照试验，共有 400 名参与者随机分配到主动或被动臂。研究臂的参与者都收到一个市售的家庭采集新冠病毒检测试剂盒，通过邮寄自采的鼻腔拭子到一个中心实验室来完成检测。主要研究结果是在 14 天内将试剂盒返回中心实验室。家庭新冠病毒检测的文化、社会、行为和经济障碍也通过定性研究方法进行评估。试验后进行调查和半结构访谈，以评估对家庭检测的看法和体验。