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OpenTrials
Completed

NCT Number: NCT04673292

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

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.

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Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2212 McElderry Street

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for households

  • 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

Inclusion criteria

for Individuals

  • Reports primary residence within the sampled household
  • Provides informed consent
  • For children (12 years of age or older), with child assent.

Exclusion criteria

for households:

  • 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

Exclusion criteria

for individuals

  • Person providing informed consent is under the influence of illicit substances

Treatment and study plan

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.

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.

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Time to Completion of SARS-CoV-2 Testing

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

    Time (In days) to completion of SARS CoV-2 testing from randomization

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Community Collaboration to Combat COVID-19

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2020
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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