Community Network-driven COVID-19 Testing of Vulnerable Populations in the Central US (C3)

• ClinicalTrials.gov Identifier: NCT04743908
• Recruitment Status: Not yet recruiting
• First Posted: February 8, 2021
• Last Update Posted: February 8, 2021
• Sponsor: University of Chicago
• Information provided by (Responsible Party): University of Chicago

Study Description

Brief Summary:

This C3 project, Community network-driven COVID-19 testing of vulnerable populations in the Central US, will implement and evaluate a COVID-19 testing approach that combines an evidence-based Social Network Testing Strategy (SNS) with community developed COVID-19 public health messages (SNS+). C3 will engage two disenfranchised populations across rural and urban sites in states across the Central US (TX, LA, AR, IN, IL). C3 leverages NIDA's Justice Community Opioid Innovation Network (JCOIN), the PIs' extensive community located COVID-19 testing programs, and a network of established community partnerships. The collaborative community-academic partnerships, research and engagement infrastructure, and team's leadership across JCOIN will ensure that C3 can rapidly recruit, enroll and test most disenfranchised community members, (n=2400) and through this process, accelerate any forthcoming COVID-19 public health prevention interventions. C3 focuses on two communities most impacted by COVID-19: 1) Criminal justice involved (CJI) - non-incarcerated people with previous history of arrest/jail/prison, probation/parole and drug-court attendance; and 2) Low-income Latinx - community members at 250% or below Federal Poverty Level. Both of these diverse populations, and the overlap between them, have some of the highest rates of COVID-19 infection and death in the United States. Messaging that affirms individual agency and corrects misinformation, combined with accessible and acceptable testing, is required to accelerate COVID-19 prevention for these populations

Condition or disease	Intervention/treatment	Phase
Covid19	Other: Social Network Strategy + COVID-19 messaging	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 2400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Using a two-arm randomized controlled trial design, participants will be enrolled into the SNS arm (involves social networking referrals only) or the SNS+messaging arm. The latter includes affirmation/misinformation correction messaging (discussion tools and coaching).
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Community Network-driven COVID-19 Testing of Vulnerable Populations in the Central US (C3)
• Estimated Study Start Date: February 2021
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Social Network Strategy (SNS Condition); This will occur towards the end of the study visit when CEC staff describe the SNS, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. CECs will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walkthrough and scenario play will be strategies to assist with planning regarding: (1) how the conversation will be raised, (2) how potential barriers to testing will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared.
Experimental: Social Network Strategy + Messaging; This will occur towards the end of the study visit when CEC staff describe the SNS, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. CECs will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walkthrough and scenario play will be strategies to assist with planning regarding: (1) how the conversation will be raised, (2) how potential barriers to testing will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared. Finally, community developed COVID-19 public health messages will be shared in the participant's preferred language.	Other: Social Network Strategy + COVID-19 messaging; Contextually adapted and theory-driven messages - misinformation correction and self-affirmation - to increase awareness, self-efficacy and community engagement in our adapted Social Network testing Strategy (SNS). SNS is an evidence-based testing intervention that has been widely used in multiple settings with marginalized individuals (ie substance-users) who facilitate the recruitment of their social contacts into testing services.

Outcome Measures

Primary Outcome Measures :

1. Total number of tests among network members referred for COVID testing (network tested) [ Time Frame: 21 days ]
   Network tested is measured at the participant level by the number of network members that are tested through the SNS.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Index community members will be:

  1. 18 years or older;
  2. spend majority of their time in the metropolitan area or county where recruited;
  3. have access to a phone for 21-day follow-up call; and

  4. primary communication in English or Spanish (based on site chart above) AND at least one of the following: (i) CJI in the previous five years (operationalized as any jail, prison, arrest, parole (completed), probation, drug court during this timeframe); (ii) lower-income Latinx (operationalized as at or below 250% of FPL).

     Social network referrals will be:

  1. linked to the index as a "friend, family, coworker or someone you spend time with on a regular basis";
  2. visit within two weeks of index visit;
  3. 18 years or older;
  4. spend the majority of their time in the metropolitan area or county where recruited;
  5. have access to a phone for 21-day follow-up call; and

  6. primary communication in English or Spanish.

     Exclusion Criteria:

  1. inability to provide informed consent; and
  2. active COVID-19 symptoms per CDC. Participants with COVID-19 symptoms will be referred for free testing at existing partners for each of the study sites.
  3. currently on parole

Contacts and Locations

Contacts

Contact: Mainza L Durrell, DrPH; 7737027589; mdurrell@medicine.bsd.uchicago.edu

Contact: Ralph Meneghetti; rmeneghetti@medicine.bsd.uchicago.edu

Sponsors and Collaborators

University of Chicago

Investigators

• Principal Investigator: John Schneider, MD; University of Chicago

More Information

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT04743908
• Other Study ID Numbers: 20-1494
• First Posted: February 8, 2021
• Last Update Posted: February 8, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Chicago:

Criminal Justice Involved; Latinx; Social Network Strategy

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases