Community Collaboration to Combat COVID-19
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
- 是
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)].)
