NCT05500274

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
778

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
4 months until next milestone

Results Posted

Study results publicly available

October 1, 2024

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

1.4 years

First QC Date

August 5, 2022

Results QC Date

July 8, 2024

Last Update Submit

May 2, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • COVID-19 Testing

    Number of participants with at least one test within 3 months of baseline.

    3 months

  • COVID-19 Vaccination

    Number of participants receiving at least one vaccination within 3 months of baseline.

    3 months

Study Arms (2)

Education Arm

ACTIVE COMPARATOR

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.

Other: Education

Motivational Arm

ACTIVE COMPARATOR

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.

Other: Motivational

Interventions

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.

Education Arm

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

Motivational Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Educational StatusMotivational Interviewing

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsDirective CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. John Schneider
Organization
The University of Chicago

Study Officials

  • John Schneider, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR
  • Russell Brewer, DrPH

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Using a two-arm 1:1 randomized controlled trial design, 778 participants were 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2022

First Posted

August 15, 2022

Study Start

January 10, 2023

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

May 18, 2025

Results First Posted

October 1, 2024

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations