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

Purpose

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.

Condition

  • Coronavirus Infection

Eligibility

Eligible Ages
Over 5 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

for households 1. Selected address within Baltimore City 2. At least one member of the household >18 years of age who speaks English and/or Spanish 3. At least one member of the household provides informed consent 4. At least one member of the household psychologically fit to complete survey Inclusion Criteria for Individuals 1. Reports primary residence within the sampled household 2. Provides informed consent 3. For children (12 years of age or older), with child assent.

Exclusion Criteria

for households: 1. Adult member of the household is under the influence of illicit substances, in the opinion of the phone interviewer 2. Residents of nursing homes, half-ways houses or shelters 3. Psychologically unfit to complete the survey 4. Not a selected household address Exclusion criteria for individuals 1. Person providing informed consent is under the influence of illicit substances

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Each household will be randomized to one of three arms in the study: Fixed site SOC testing (Arm 1), community-based, mobile van testing (Arm 2), or self-collected, home-based testing (Arm 3).
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Fixed site SOC testing 		Fixed site Standard of Care (SOC) testing
  • Behavioral: Fixed site standard of care testing
    This arm includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system. Participants will be given a choice of 1 of 3 outdoor testing locations based on their preferences. Study staff will make an appointment for testing based on testing availability and participant schedule.
Experimental
Community-based testing 		Community-based, mobile van testing
  • Behavioral: Community-based, mobile van testing
    This arm offers the convenience of highly accessible testing and with the flexibility of no fixed appointment time. Each of the 12 geographic strata will have a single, centrally located testing site within the area, providing similar geographic access across households. The testing location will be published on the study website and social media so that participants can visit the location at a time convenient to them.
Experimental
Self-collected testing 		Self-collected, home-based testing
  • Behavioral: Self-collected, home-based testing
    Individuals will receive a home-based testing kit delivered by a courier service as soon as the randomization of the household is complete. The kit will include provisions for contacting the courier service for pick up. Appropriate biohazard precautions are included. Each of the testing components of this kit will include FDA Emergency Use Authorization approved collection methods. Easy to use instructions with options to view pre-recorded videos and/or virtual 'on demand' coaching sessions with members of the study team via a HIPAA-secure Zoom session will be available.

Recruiting Locations

More Details

NCT ID
NCT04673292
Status
Completed
Sponsor
Johns Hopkins University

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.