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

Coronavirus Infection Clinical Trial

Official title:

Community Collaboration to Combat COVID-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04673292
• Other study ID #: IRB00250298
• Secondary ID: P30AI094189-09S1
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: June 2024
• Est. primary completion date: June 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	2212 McElderry Street	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Receipt of SARS-CoV-2 testing results	Proportion of those who complete a survey who agree to be randomized to a SARS-CoV-2 testing modality.	Measured from baseline survey completion to enrollment within 30 days of completion of baseline survey
Secondary	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 from randomization to testing completion (within 30 days of randomization)
Secondary	Time to completion of SARS CoV-2 testing	Time (In days) to completion of SARS CoV-2 testing from randomization.	Measured from randomization to testing completion (Within 20 days of randomization)
Secondary	Time from SARS CoV-2 testing to receipt of results	Time (in days) from SARS CoV-2 testing completion to the receipt of results by the participant.	Measured from testing completion to receipt of results (within 10 days of testing)