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

NCT04673292 | Completed Results DMC

• 2 other identifiers: IRB00250298P30AI094189-09S1
• Study Type: interventional
• Target: 831
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection

Outcome Measures

Primary Outcomes (1)

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

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

  Measured within 30 days of randomization/consent

Secondary Outcomes (2)

• Time to Completion of SARS-CoV-2 Testing

  Measured from randomization to testing completion (within 30 days of randomization)].

• Time From SARS CoV-2 Testing to Receipt of Results

  Measured from testing completion to receipt of results (within 10 days of testing)

Study Arms (3)

Fixed site SOC testing

EXPERIMENTAL

Fixed site Standard of Care (SOC) testing

Behavioral: Fixed site standard of care testing

Community-based testing

EXPERIMENTAL

Community-based, mobile van testing

Behavioral: Community-based, mobile van testing

Self-collected testing

EXPERIMENTAL

Self-collected, home-based testing

Behavioral: Self-collected, home-based testing

Interventions

Fixed site standard of care testing BEHAVIORAL

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.

Fixed site SOC testing

Community-based, mobile van testing BEHAVIORAL

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.

Community-based testing

Self-collected, home-based testing BEHAVIORAL

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.

Self-collected testing

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Adult member of the household is under the influence of illicit substances, in the opinion of the phone interviewer
• Residents of nursing homes, half-ways houses or shelters
• Psychologically unfit to complete the survey
• Not a selected household address
• \. Person providing informed consent is under the influence of illicit substances

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

2212 McElderry Street

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Jacky Jennings,PhD, MPH; Shruti Mehta, PhD, MPH; Jason Farley, PhD, MPH, ANP-BC, FAAN
• Organization: Johns Hopkins School of Medicine; Johns Hopkins Bloomberg School of Public Health; Johns Hopkins University School of Nursing

jennings@jhmi.edu; smehta@jhu.edu; jfarley1@jhu.edu

410-550-4132

Study Officials

• Jason E Farley, PhD, MPH, NP

  Johns Hopkins University School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 17, 2020
• Study Start: February 8, 2021
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2023
• Last Updated: July 8, 2024
• Results First Posted: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)