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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05500274
Enrollment
778
Registered
2022-08-15
Start date
2023-01-10
Completion date
2024-05-31
Last updated
2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

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).

Interventions

OTHEREducation

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.

OTHERMotivational

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

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
COVID-19 Testing3 monthsNumber of participants with at least one test within 3 months of baseline.
COVID-19 Vaccination3 monthsNumber of participants receiving at least one vaccination within 3 months of baseline.

Countries

United States

Participant flow

Pre-assignment details

A total of 1235 participants were screened, 936 were eligible, and 778 consented. Baseline surveys could be completed remotely, but intervention sessions required in-person attendance. Randomization occurred only when participants were physically present. Some participants did not attend due to scheduling conflicts and were not randomized.

Participants by arm

ArmCount
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. Education: 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.
378
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. Motivational: 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
400
Total778

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up7651
Overall StudyNot able to complete the session and follow-up visits.715

Baseline characteristics

CharacteristicEducation ArmTotalMotivational Arm
Age, Continuous43.7 years
STANDARD_DEVIATION 14.7
42.9 years
STANDARD_DEVIATION 14.6
42.5 years
STANDARD_DEVIATION 14.5
COVID-19 Testing378 Participants778 Participants400 Participants
COVID-19 Vaccination378 Participants778 Participants400 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
61 Participants128 Participants67 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
317 Participants650 Participants333 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Asian
48 Participants109 Participants61 Participants
Race (NIH/OMB)
Black or African American
316 Participants650 Participants334 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
10 Participants11 Participants1 Participants
Race (NIH/OMB)
White
3 Participants6 Participants3 Participants
Sex/Gender, Customized
Female
180 Participants361 Participants181 Participants
Sex/Gender, Customized
Intersex
0 Participants1 Participants1 Participants
Sex/Gender, Customized
Male
156 Participants349 Participants193 Participants
Sex/Gender, Customized
Unknown, Refused, or Missing
2 Participants5 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3780 / 400
other
Total, other adverse events
0 / 3780 / 400
serious
Total, serious adverse events
0 / 3780 / 400

Outcome results

Primary

COVID-19 Testing

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

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Education ArmCOVID-19 Testing378 Participants
Motivational ArmCOVID-19 Testing400 Participants
Primary

COVID-19 Vaccination

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

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Education ArmCOVID-19 Vaccination378 Participants
Motivational ArmCOVID-19 Vaccination400 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026