Community Collaboration to Combat COVID-19 (C-FORWARD)

Not Applicable

Completed

Conditions: Coronavirus Infection

Interventions: Behavioral: Community-based, mobile van testing
Behavioral: Self-collected, home-based testing
Behavioral: Fixed site standard of care testing

Registration Number: NCT04673292

Lead Sponsor: Johns Hopkins University

Brief Summary: 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.

Detailed Description: 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.

Outcomes related to testing will be measured within 30 days of the initial randomization. Participants will be followed with weekly symptom pulses and monthly follow-up visits to ascertain subsequent testing need/COVID-19 symptoms. Testing during follow-up will be on-demand and participants can use either the fixed site or the home-based testing kits. The investigators will measure the impact of the time to receipt of SARS CoV-2 testing results.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 831

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community-based testing	Community-based, mobile van testing	Community-based, mobile van testing
Self-collected testing	Self-collected, home-based testing	Self-collected, home-based testing
Fixed site SOC testing	Fixed site standard of care testing	Fixed site Standard of Care (SOC) testing

Primary Outcome Measures

Name	Time	Method
Uptake of SARS-CoV-2 Testing as Assessed by Proportion of Participants Who Complete Testing	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.

Secondary Outcome Measures

Name	Time	Method
Time From SARS CoV-2 Testing to Receipt of Results	Measured from testing completion to receipt of results (within 10 days of testing)	Time (in days) from SARS CoV-2 testing completion to the receipt of results by the participant.
Time to Completion of SARS-CoV-2 Testing	Measured from randomization to testing completion (within 30 days of randomization)].	Time (In days) to completion of SARS CoV-2 testing from randomization