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临床试验/NCT04673292
NCT04673292已完成不适用

Community Collaboration to Combat COVID-19

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 831 人开始时间: 2021年2月8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
831
试验地点
2
主要终点
Uptake of SARS-CoV-2 Testing as Assessed by Proportion of Participants Who Complete Testing

研究概览

简要总结

This is randomized trial where households will be randomized to identify the optimal SARS-CoV-2 (COVID-19) testing modality in a population-representative sample of households in Baltimore City, Maryland. 1,386 households in Baltimore City will be randomized 1:1:1 to one of three testing modalities: 1) fixed-site standard of care testing; 2) community-based mobile van testing; or 3) self-collected home, based testing.

详细描述

The target population will include English- and Spanish-speaking families residing in Baltimore City households (N=238,427). The sample size goal is 1,386 households (0.44% of households) or 3,000 individual household members. Households will be sampled using a multi-stage approach with 1) selection of 105 of 653 census block groups (CBGs) with probabilities proportional to the estimated number of occupied households selected from 9 strata of CBGs defined by socioeconomic status and race/ethnicity with over-sampling of CBGs with harder-to-reach populations (e.g., Latinos/x, low-income whites); 2) selection of residential addresses within each of the strata via non-linear optimization; and finally, 3) screening of individuals selected for eligibility (e.g., household occupied vs. not, English/Spanish speaking).

After completion of brief surveys, individuals will be asked to enroll other willing household members. One adult member of the household will be randomized 1:1:1 using a stratified, blocked approach with varying block sizes of 3, to one of three testing modalities: 1) fixed site standard of care testing; 2) community-based mobile van testing; or 3) self-collected home, based testing. Randomization will be stratified by geography (n=12 zones) and race/ethnicity (non-hispanic white/other, non-hispanic black and hispanic/latinx).

Arm 1 includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system.

Arm 2 includes a convenient, accessible mobile van option which will be located in the center of each of 12 geographic zones.

Arm 3 includes a home-based testing kit which will be delivered by courier service.

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
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Uptake of SARS-CoV-2 Testing as Assessed by Proportion of Participants Who Complete Testing

时间窗: Measured within 30 days of randomization/consent

Uptake of SARS CoV-2 testing will be assessed by proportion of participants who are randomized and complete SARS CoV-2 testing.

次要结局

  • Time From SARS CoV-2 Testing to Receipt of Results(Measured from testing completion to receipt of results (within 10 days of testing))
  • Time to Completion of SARS-CoV-2 Testing(Measured from randomization to testing completion (within 30 days of randomization)].)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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