COVID-19
Conditions
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
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.
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 Testing | 3 months | Number of participants with at least one test within 3 months of baseline. |
| COVID-19 Vaccination | 3 months | Number 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
| Arm | Count |
|---|---|
| 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 |
| Total | 778 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 76 | 51 |
| Overall Study | Not able to complete the session and follow-up visits. | 7 | 15 |
Baseline characteristics
| Characteristic | Education Arm | Total | Motivational Arm |
|---|---|---|---|
| Age, Continuous | 43.7 years STANDARD_DEVIATION 14.7 | 42.9 years STANDARD_DEVIATION 14.6 | 42.5 years STANDARD_DEVIATION 14.5 |
| COVID-19 Testing | 378 Participants | 778 Participants | 400 Participants |
| COVID-19 Vaccination | 378 Participants | 778 Participants | 400 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 61 Participants | 128 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 317 Participants | 650 Participants | 333 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 48 Participants | 109 Participants | 61 Participants |
| Race (NIH/OMB) Black or African American | 316 Participants | 650 Participants | 334 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 11 Participants | 1 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 3 Participants |
| Sex/Gender, Customized Female | 180 Participants | 361 Participants | 181 Participants |
| Sex/Gender, Customized Intersex | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Male | 156 Participants | 349 Participants | 193 Participants |
| Sex/Gender, Customized Unknown, Refused, or Missing | 2 Participants | 5 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 378 | 0 / 400 |
| other Total, other adverse events | 0 / 378 | 0 / 400 |
| serious Total, serious adverse events | 0 / 378 | 0 / 400 |
Outcome results
COVID-19 Testing
Number of participants with at least one test within 3 months of baseline.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Education Arm | COVID-19 Testing | 378 Participants |
| Motivational Arm | COVID-19 Testing | 400 Participants |
COVID-19 Vaccination
Number of participants receiving at least one vaccination within 3 months of baseline.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Education Arm | COVID-19 Vaccination | 378 Participants |
| Motivational Arm | COVID-19 Vaccination | 400 Participants |