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

NCT04673292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 831

Last updated 2024-07-08

Study results available
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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.

Conditions

  • Coronavirus Infection

Interventions

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.

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Jason E Farley, PhD, MPH, NP · Johns Hopkins University School of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-08
Primary Completion
2023-06-09
Completion
2023-06-09

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04673292 on ClinicalTrials.gov