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临床试验/NCT04847479
NCT04847479已完成不适用

Close Contact Self-Testing Among Contacts of Individuals With COVID-19 Infection

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2021年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
2
主要终点
Number of Positive Contacts

研究概览

简要总结

Widespread testing and contact tracing are critical to controlling the COVID-19 epidemic. Distribution of COVID-19 self-test kits can augment public health contact tracing efforts, as individuals with COVID-19 can distribute self-testing to close contacts. This approach can increase case detection by facilitating testing among exposed individuals, and potentially ameliorate stigma, fear, and medical mistrust associated with COVID-19 among vulnerable populations.

The central hypothesis of this study is that distribution of SARS-CoV-2 self-tests to close contacts of among individuals with COVID-19 infection can increase case detection compared with a standard contact referral strategy.

详细描述

Strategies to increase testing among individuals exposed to COVID-19 are needed. One approach to increase testing and case detection is to distribute home test kits to close contacts of individuals with COVID-19. This approach decreases logistic barriers to testing, potential exposures to COVID-19, and reduces potential stigma and fear associated with facility-based COVID-19 testing.

The investigators will conduct a cohort study of individuals diagnosed with COVID-19 in the C-STRAND trial (NCT04797858), in order to determine if distribution of self-test kits to close contacts of of individuals with COVID-19 can increase case detection compared with a standard contact referral strategy among. Individuals diagnosed with COVID-19 who were randomized to the self-test (intervention) arm or received self-test kits will be assigned to receive additional self-test kits to distribute to close contacts. Individuals diagnosed with COVID-19 who were randomized to the test referral (control) arm or received test referrals will be assigned to receive text message referrals to give their close contacts to seek testing if needed. COVID-19 case detection and test uptake will be measured in both arms.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • 18 years of age or older
  • Has a working telephone number
  • Willing and able to provide informed consent

排除标准

  • Severe symptoms requiring immediate medical attention
  • Younger than 18 years of age
  • Does not have a working telephone number
  • Unable or unwilling to provide informed consent

结局指标

主要结局

Number of Positive Contacts

时间窗: 8 weeks

Number of close contacts who test positive for COVID-19

次要结局

  • Number of Positive Contacts (End of Study)(Through study completion, up to one year)
  • Number of Contacts Tested(8 weeks)
  • Number of Contacts Tested (End of Study)(Through study completion, up to one year)
  • Number of Household Contacts Tested(8 weeks)
  • Number of Household Contacts Tested (End of Study)(Through study completion, up to one year)

研究者

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

Robert Gross

Professor of Medicine

University of Pennsylvania

研究点 (2)

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