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Social Network Diffusion of COVID-19 Prevention for Diverse Criminal Legal Involved Communities

Primary Purpose

COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Motivational
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age
  • Spend majority of their time in the metropolitan area or county where recruited
  • Primary communication in English
  • Previous direct or indirect exposure to law enforcement.

Exclusion Criteria:

  • Inability to provide informed consent; and
  • Active COVID-19 symptoms per CDC guidelines.

Sites / Locations

  • University of ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Education Arm

Motivational Arm

Arm Description

The Education condition will include COVID-19 prevention messaging and an interactive activity reinforcing the messages. Testimonial videos will be played including those that describe the testing experience and motivations for testing. This approach combines self-affirmation with misinformation correction to take advantage of the ability to promote adaptive COVID-19 prevention behaviors.

Study participants randomized to the Motivational Intervention will receive the intervention using a social network diffusion approach. This is a Type I network intervention that includes specific training on mobilization of network members. The Motivational intervention will be based upon a previous workshop divided into four learning and practice modules.

Outcomes

Primary Outcome Measures

COVID-19 Testing
Probability of receiving at least one test within 3 months of baseline. The primary outcome analysis will compare the probability of testing among participants assigned to Educational vs. Motivational intervention.
COVID-19 Vaccination
Probability of receiving at least one vaccination within 3 months of baseline. The primary outcome analysis will compare the probability of vaccination among participants assigned to Educational vs. Motivational intervention.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2022
Last Updated
May 5, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05500274
Brief Title
Social Network Diffusion of COVID-19 Prevention for Diverse Criminal Legal Involved Communities
Official Title
Social Network Diffusion of COVID-19 Prevention for Diverse Criminal Legal Involved Communities
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

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
Yes

5. Study Description

Brief Summary
The "Social network diffusion of COVID-19 prevention for diverse Criminal Legal Involved Communities" study will engage people who have been interacted with law enforcement in COVID-19 prevention (testing and/or vaccination) through social network mobilization combined with theory-driven COVID-19 prevention messaging delivered in an interactive group format. Eligible individuals will be enrolled into a two-arm 1:1 randomized controlled trial design. 800 participants will be enrolled into either a: 1) COVID-19 prevention education arm (Education Arm) or, 2) a network mobilization change agent intervention (Motivational Arm).
Detailed Description
The "Social network diffusion of COVID-19 prevention for diverse Criminal Legal Involved Communities" study will implement a situation appropriate COVID-19 testing and vaccination social network diffusion intervention - C3 - building upon RADx-UP Phase I lessons and successful social network prevention interventions developed previously by the research team. C3 Criminal Legal Involved (CLI) populations encompass those non-incarcerated who have experienced recent arrest, incarceration, probation, parole or diversion programs such as drug courts. While increases in COVID-19 testing have been observed among this group, there remain members with limited testing history as well as individuals who are vaccine hesitant. COVID-19 prevention messaging can no longer be simplified to "everyone test and/or everyone vaccinate" as testing and vaccination decisions among community members are sensitive to personal histories (i.e., prior infection), local infection rates (i.e., low rates) and testing/vaccination availability. As COVID-19 prevention efforts have become more complicated (i.e., test if exposed), people tend to focus on the messenger, and particularly those that are close to them. Personal connections and communications within existing personal network structures, such as families, friends and other trusted acquaintances represent the cornerstone to increase situation appropriate testing and overcoming COVID-19 vaccine hesitancy. C3 builds upon RADx-UP I, by using a network diffusion approach facilitated through motivational interviewing purposefully geared to mobilize one's own organic social network to increase context appropriate testing and vaccine uptake. Through this process we will maximize the primary benefit and impact of this type of intervention which also has the intended effect of increasing likelihood that the messenger themselves will undergo the same behavior change that they have been trained to promote. We will leverage infrastructure developed in RADx-UP Phase I, which includes 4 high-impact sites across the Central US from Phase I: Baton Rouge LA, Little Rock AR, Indianapolis IN, and Chicago IL. We will utilize established engagement efforts already in place and continue to fully integrate communities in the strategic application of the intervention. We will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to guide implementation. C3 aims to: Aim 1a. Test the efficacy (3-month situation appropriate testing or vaccination) of a network diffusion intervention (C3) versus an existing COVID-19 testing and vaccine linkage to care intervention among: 1) primary study participants (primary outcome); and 2) secondary study participants connected to primary participants (secondary outcome) using a RCT design. Aim 1b. Explore the mechanisms for differential intervention effects at the individual and network-level that may increase situation appropriate testing and/or vaccination uptake. Aim 2. Examine key RE-AIM components in real time tied to the implementation of the network diffusion intervention (C3).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Using a two-arm 1:1 randomized controlled trial design, 800 participants will be enrolled into either a: 1) COVID-19 prevention education arm (Education Arm) or, 2) a network mobilization change agent intervention (Motivational Arm); the latter is a Type I network intervention that includes specific training on mobilization of network members which we have adapted to COVID-19 from HIV prevention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education Arm
Arm Type
Active Comparator
Arm Description
The Education condition will include COVID-19 prevention messaging and an interactive activity reinforcing the messages. Testimonial videos will be played including those that describe the testing experience and motivations for testing. This approach combines self-affirmation with misinformation correction to take advantage of the ability to promote adaptive COVID-19 prevention behaviors.
Arm Title
Motivational Arm
Arm Type
Active Comparator
Arm Description
Study participants randomized to the Motivational Intervention will receive the intervention using a social network diffusion approach. This is a Type I network intervention that includes specific training on mobilization of network members. The Motivational intervention will be based upon a previous workshop divided into four learning and practice modules.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Testimonial videos will be played including those that describe the testing experience and their motivations for testing. This approach combines self-affirmation with misinformation correction to take advantage of the ability to promote adaptive COVID-19 prevention behaviors. The self-affirmation activity will always precede the presentation of the testimonial videos as leading with misinformation correction can be construed by some as a threat to one's self-adequacy.
Intervention Type
Other
Intervention Name(s)
Motivational
Intervention Description
This is a Type I network intervention that includes specific training on mobilization of network members. Training occurs in a group-based setting of 8-10 enrolled participants facilitated by a community facilitator and Motivational Interviewing trained interventionist. At 30 days, a 15-20-minute phone booster communication session reinforces the intervention content
Primary Outcome Measure Information:
Title
COVID-19 Testing
Description
Probability of receiving at least one test within 3 months of baseline. The primary outcome analysis will compare the probability of testing among participants assigned to Educational vs. Motivational intervention.
Time Frame
3 months
Title
COVID-19 Vaccination
Description
Probability of receiving at least one vaccination within 3 months of baseline. The primary outcome analysis will compare the probability of vaccination among participants assigned to Educational vs. Motivational intervention.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years of age Spend majority of their time in the metropolitan area or county where recruited Primary communication in English Previous direct or indirect exposure to law enforcement. Exclusion Criteria: Inability to provide informed consent; and Active COVID-19 symptoms per CDC guidelines.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mainza Durrell, DrPH
Phone
7737026004
Email
mdurrell@medicine.bsd.uchicago.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Camille Demarco, MPH
Phone
7738343755
Email
camilledemarco@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Schneider, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Russell Brewer, DrPH
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mainza Durrell, DrPH
Email
mdurrell@medicine.bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
John A Schneider, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Social Network Diffusion of COVID-19 Prevention for Diverse Criminal Legal Involved Communities

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