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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Network Strategy + COVID-19 messaging
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring Criminal Justice Involved, Latinx, Social Network Strategy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Social Network Strategy (SNS Condition)

Social Network Strategy + Messaging

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total number of tests among network members referred for COVID testing (network tested).
Network tested is measured at the participant level by the number of network members that are tested through the SNS.
Total number of vaccinations among study participants given COVID vaccine information (number vaccinated)
Number vaccinated is measured at the participant level by the number of study participants that are vaccinated through the SNS.

Secondary Outcome Measures

Full Information

First Posted
February 5, 2021
Last Updated
May 5, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04743908
Brief Title
Community Network-driven COVID-19 Testing and Vaccination of Vulnerable Populations in the Central US
Acronym
C3
Official Title
Community Network-driven COVID-19 Testing and Vaccination of Vulnerable Populations in the Central US (C3)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Criminal Justice Involved, Latinx, Social Network Strategy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
1328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social Network Strategy (SNS Condition)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Social Network Strategy + Messaging
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Social Network Strategy + COVID-19 messaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total number of tests among network members referred for COVID testing (network tested).
Description
Network tested is measured at the participant level by the number of network members that are tested through the SNS.
Time Frame
12 months
Title
Total number of vaccinations among study participants given COVID vaccine information (number vaccinated)
Description
Number vaccinated is measured at the participant level by the number of study participants that are vaccinated through the SNS.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Index community members will be: 18 years or older; spend majority of their time in the metropolitan area or county where recruited; have access to a phone for 21-day follow-up call; and 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: linked to the index as a "friend, family, coworker or someone you spend time with on a regular basis"; visit within two weeks of index visit; 18 years or older; spend the majority of their time in the metropolitan area or county where recruited; have access to a phone for 21-day follow-up call; and primary communication in English or Spanish. Exclusion Criteria: inability to provide informed consent; and 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. currently on parole
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Schneider, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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