C3: Community Network-driven COVID-19 Testing and Vaccination of Vulnerable Populations in the Central US

Sponsor
University of Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT04743908
Collaborator
(none)
2,400
1
2
31.1
77.2

Study Details

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 and vaccination 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 (Texas (TX), Louisiana (LA), Arkansas (AR), Indiana (IN), Illinois (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
  • Other: Social Network Strategy + COVID-19 messaging
N/A

Study Design

Study Type:
Interventional
Anticipated 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).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 and Vaccination of Vulnerable Populations in the Central US (C3)
Actual Study Start Date :
Apr 29, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Social Network Strategy (SNS Condition)

Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff 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

Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walk through 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). [12 months]

    Network tested is measured at the participant level by the number of network members that are tested through the SNS.

  2. Total number of vaccinations among study participants given COVID vaccine information (number vaccinated) [12 months]

    Number vaccinated is measured at the participant level by the number of study participants that are vaccinated through the SNS.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 University of Chicago Chicago Illinois United States 60637

Sponsors and Collaborators

  • University of Chicago

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT04743908
Other Study ID Numbers:
  • IRB20-1494
First Posted:
Feb 8, 2021
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2022