Clinical trial NCT05500274: 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
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-08-15
Enrollment: 778
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: COVID-19 Testing
timeFrame: 3 months
measure: COVID-19 Vaccination
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: John Schneider, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Russell Brewer, DrPH
role: PRINCIPAL_INVESTIGATOR
References: