- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05500274
Social Network Diffusion of COVID-19 Prevention for Diverse Criminal Legal Involved Communities
May 5, 2023 updated by: University of Chicago
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).
Study Overview
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).
Study Type
Interventional
Enrollment (Anticipated)
800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mainza Durrell, DrPH
- Phone Number: 7737026004
- Email: mdurrell@medicine.bsd.uchicago.edu
Study Contact Backup
- Name: Camille Demarco, MPH
- Phone Number: 7738343755
- Email: camilledemarco@bsd.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- University Of Chicago
-
Contact:
- Mainza Durrell, DrPH
- Email: mdurrell@medicine.bsd.uchicago.edu
-
Principal Investigator:
- John A Schneider, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Education Arm
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.
|
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.
|
Active Comparator: Motivational Arm
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID-19 Testing
Time Frame: 3 months
|
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.
|
3 months
|
COVID-19 Vaccination
Time Frame: 3 months
|
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.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Schneider, MD, University Of Chicago
- Principal Investigator: Russell Brewer, DrPH, University Of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2023
Primary Completion (Anticipated)
May 1, 2024
Study Completion (Anticipated)
November 1, 2024
Study Registration Dates
First Submitted
August 5, 2022
First Submitted That Met QC Criteria
August 11, 2022
First Posted (Actual)
August 15, 2022
Study Record Updates
Last Update Posted (Actual)
May 8, 2023
Last Update Submitted That Met QC Criteria
May 5, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB22-0732
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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