Social Network Diffusion of COVID-19 Prevention for Diverse Criminal Legal Involved Communities
Phase: NA
Conditions: COVID-19
Sponsor: University of Chicago

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SOCIAL NETWORK DIFFUSION OF COVID-19 PREVENTION FOR DIVERSE CRIMINAL 
LEGAL INVOLVED COMMUNITIES 
 
 
Lead Investigators:  
 
JOHN SCHNEIDER, MD, MPH 
ASSOCIATE PROFESSOR 
THE UNIVERSITY OF CHICAGO 
CHICAGO, ILLINOIS 
 
RUSSELL BREWER, DRPH, MPH 
RESEARCH ASSOCIATE PROFESSOR  
THE UNIVERSITY OF CHICAGO 
CHICAGO, ILLINOIS 
 
 
 
 
 
 
 
 
 
Protocol Version 2023.11.20 (Appendices not included); University of Chicago IRB Approved 2024.02.14 
NCT05500274 
 
 
 
 
 
 
 

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List of Appendices 
Appendix A  
Multisite Study Activities  
Appendix B 
Recruitment Materials - Main Study (Social Media, Flyer and Script) 
Appendix C 
Covid-19 Symptom Screener 
Appendix D 
Locator Form  
Appendix E 
C3 ROI 
Appendix F 
Baseline Survey 
Appendix G 
Curricula Outline 
Appendix H 
Day 30 Assessment and Booster - Motivational Group  
Appendix I 
Day 30 Assessment and Booster - Educational Group 
Appendix J 
Day 90 Assessment  
Appendix K 
How To Collect Anterior Nasal Specimen for COVID-19  
Appendix L 
What Your Test Results Mean 
Appendix M 
Key Things to Know About COVID-19 Vaccines 
Appendix N 
Qualitative Study Addendum Protocol 
Appendix O 
Qualitative Study Interview Guide 
Appendix P 
Qualitative Study Survey 
Appendix Q 
Recruitment Materials - Qualitative Study (Phone/Email Scripts) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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BACKGROUND 
The “Social network diffusion of COVID-19 prevention for diverse Criminal Legal Involved 
Communities”, will implement a situation appropriate COVID-19 testing and vaccination social network 
diffusion intervention – C3. C3 builds upon RADx-UP Phase I lessons and successful social network 
prevention interventions developed previously by the research team.1-3 COVID-19 prevention 
messaging can no longer be simplified to “everyone test and/or everyone vaccinate” as testing and 
vaccination personal decisions are situation appropriate and sensitive to prior histories (i.e., prior 
infection), local infection rates (i.e., low rates) and testing/vaccination availability. As COVID-19 
prevention efforts have become more situation appropriate (i.e., test if exposed), people tend to focus 
on the messenger33, and particularly those that are close to them. Those who are vaccine hesitant, for 
example, report that the top reason they would change their mind is if close friends or family were 
vaccinated4, a finding similar to other health behaviors.4,5,6 Personal connections and communications 
within existing personal network structures, such as families and friends represent the cornerstone to 
increase situation appropriate testing and overcoming COVID-19 vaccine hesitancy. Appropriate and 
timely messaging that local networks can utilize to make situation specific decisions (i.e., test if 
symptomatic) is urgently required for disenfranchised populations that do not want testing/vaccination, 
are concerned about safety or are not sure.  
 
Social network driven diffusion of innovation interventions (Type 1 or popular opinion leader network 
interventions)8 utilize peer change agents who are trained as part of the intervention to motivate 
network members around behavior change and represents an approach that can rapidly move beyond 
individual-level behavioral change interventions.8  Our work and that of others suggests that biomedical 
innovation uptake can be driven by information and influence within personal networks that organically 
exist.1,2,4,5, Reaching vulnerable and disenfranchised populations can be straightforward as many 
community members often obtain and transmit information primarily through their informal social 
networks, especially their friends and family.9,10 By leveraging trusted voices and support systems that 
already exist within affected populations11, network interventions embody more than a process of 
information diffusion and behavioral modeling via influential peers (i.e., the influence dimension); they 
also strengthen community connectedness12, build community resilience13 and facilitate community-
directed action14 (i.e., the empowerment dimension). We believe that these cascading network effects 
are key for facilitating longer-term community-level change.  
 
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 situation 
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.15-20 We will leverage infrastructure developed in RADx-UP Phase I, which includes 4 high-
impact sites across the Central US that are also the highest recruitment sites from Phase I: Baton 
Rouge LA, Little Rock AR, Indianapolis IN, and Chicago IL and engage individuals who have directly 
and/or indirectly interacted with law enforcement (ILE). We will utilize established engagement efforts 
already in place and continue to fully integrate communities in the strategic application of the 
intervention through our COVID-19 Community Advisory Board.  
STUDY DESIGN 

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The scientific premise of C3 is to 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 C3. Using 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); 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.2,3 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. 
Information on the personal social network members of these participants will be collected during the 
study visit (estimated at n~2-4/participant, total~3,200) using a network elicitation and collection 
approach prior to randomization as in previous work.1,2 
 
Primary outcomes are: 1) the number of study participants who undergo COVID-19 testing (situation 
appropriate) at 3 months; and 2) the number of study participants who receive at least one COVID-19 
vaccine dose at 3 months. Secondary outcomes are the same as primary, except measured among 
people who are in the networks of primary participants (referred to as secondary subjects moving 
forward). Additional secondary outcomes include: COVID-19 testing and vaccination knowledge; intent 
to receive a COVID-19 test or vaccination, and intent to participate in a future vaccine trial. Additional 
analyses will begin to understand the complex relationships between testing and vaccine statuses and 
proclivity to test (and potentially obtain a vaccine booster) among both study participants and their 
network members. For example, do those who are vaccinated serve as more effective change agents? 
Are vaccinated persons more or less likely to test compared to unvaccinated persons? Are people with 
prior COVID infection less likely to get vaccinated than those without a known history of infection? We 
have leveraged the RADx-UP phase I infrastructure to adapt the intervention resulting in C3.  
 
AIMS 
Aim 1a. Test the efficacy (3-month situation appropriate testing or vaccination) of a network diffusion 
motivational intervention versus an educational intervention among: 1) primary study participants 
(primary outcome); and 2) secondary study subjects connected to primary participants (secondary 
outcome) using a randomized controlled trial design.    
 
Aim 1b. Examine differential intervention effects by individual and network-level characteristics that 
may increase situation appropriate testing and/or vaccination uptake, such as age, prior COVID-19 
infection, mental health status, historical trauma, early adopter status, COVID-19 prevention behaviors, 
government mistrust, network testing/vaccination and prior infection, and network density. We will also 
explore hypothesized individual and network level mechanisms through which the intervention works 
(e.g., increased knowledge, self-efficacy, trust).  
 
STUDY SITES 
The sample (n=800 primary participants and n~3,200 secondary subjects (~2-4 network members per 
participant) will be spread across four jurisdictions: Baton Rouge, LA; Little Rock, AR; Chicago, IL and 
Indianapolis, IN. 
 
 
 
 
 

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Table 1: Breakdown of study sites 
 
This multi-site study will be completed at four sites as shown in Table 1. Upon IRB approval, these sites 
will participate in research activities as listed in Appendix A, including recruitment, participant 
engagement and interviews. Study activities will be conducted by IRB approved study staff and faculty 
at the study center shown in Table 1, or in a private room at a community based organization, public 
library or school.  If the study interaction takes place at these locations, study activities will be 
conducted by IRB approved study staff who will ensure that subjects have complete privacy.   
 
University of Chicago will provide pre-programmed laptops to all study sites. These laptops have been 
programmed by the Research Computing Group within the Department of Public Health Sciences 
(leadership Phil Schumm) at the University of Chicago to ensure data protection and enable data 
transfer. All data collection will be conducted electronically via laptops and data will be uploaded into 
databases hosted by University of Chicago. These are similar procedures as have been developed with 
Schumm for NIDA’s Methodology and Advanced Analytics Research Center (PI Schneider). 
 
The University of Chicago BSD IRB will act as IRB of Record for Chicago, Arkansas, and Baton Rouge. 
Indiana University will utilize their own IRB due to their enrollment of juvenile CJI populations.  
 
METHODS 
 
Aim: Test the efficacy (3-month situation appropriate testing or vaccination) of the Motivation 
Intervention versus the Education intervention among: 1) primary study participants (primary 
Study Sites 
Site Lead 
Stakeholders 
IRB of Record 
Sample Size(n) 
Chicago, IL 
University of Chicago 
Schneider 
Chicago Dept. of Public Health 
University of 
Chicago IRB 
150 
Pulaski Cnty., AR 
University of Arkansas 
for Medical Sciences 
Zaller,  
 
Arkansas Dept of Health and Central 
Arkansas Housing Corporation 
(CAHC) 
University of 
Chicago IRB 
250 
Baton Rouge, LA 
Capitol Area Reentry 
Program (CARP) 
Brewer 
Aspire Health Care 
 
University of 
Chicago IRB 
250 
Indianapolis, IN 
Indiana University 
Aalsma, 
Knopf 
Inner Beauty, New B.O.Y., VOICES   
Indiana University 
IRB 
150 
Northwestern 
University 
Evanston, IL 
Pyra 
NA 
University of 
Chicago IRB 
NA 
NORC 
Leslie Watson 
 
All study sites.  NORC will assist with 
site management and training, as well 
as study design and data analysis. 
 
University of 
Chicago IRB 
NA 

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outcome); and 2) secondary study subjects connected to primary participants (secondary 
outcome) using a randomized controlled trial design.    
 
We hypothesize that primary study participants randomized to receive the Motivational intervention 
condition (tailored motivational messaging plus network diffusion in a group setting with 1-month 
booster communication) will be more likely to get tested and/or vaccinated within 3 months of the 
intervention as compared to COVID-19 Education condition alone (attention control). We also 
hypothesize that Motivational intervention will result in more secondary study subjects (network 
members of primary participants) will receive testing and/or vaccination within 3 months. Finally, we 
anticipate that there may be differential intervention effects across participant characteristics across 
study sites, by mental health, exposure to law enforcement, prior COVID-19 infection, testing 
frequency, age and network composition, and will explore these sub-group differences in the context of 
any power limitations.  
 
 
RECRUITMENT OF STUDY PARTICIPANTS 
We will enroll 800 study participants ages ≥18 years of age across all four sites. Study participants will 
be recruited by local research assistants (RAs) embedded within community settings that provide a 
number of in-person and remote social and care services, including community COVID-19 testing and 
vaccination. We will utilize several strategies that we have utilized previously.22,54-58  
 
Recruitment activities may include: 
• 
In-person recruitment may be conducted at the study center (Table 1), during regular drop-in 
and community-based services, and events occurring at the study center and its outreach 
programs. This may include providing a study flyer or contact card so that a client can contact 
the study team directly about participation. A sign-up sheet may also be provided, where 
interested clients can provide their contact information if they wish to be contacted by the study 
team about the study. 
• 
Flyers posted at study centers  
• 
Social media postings 
• 
Contacting individuals from previous studies who have indicated interest in being contacted for 
future work or from existing community programs. 
All participants will be asked to sign a release of information so that the study team receives COVID-19 
testing/vaccination results as part of existing COVID-19 testing and vaccine registries in the four 
locations. 
 
Inclusion and Exclusion Criteria.  
 
Inclusion Criteria:  
(1) ≥18 years of age  
(2) spend majority of their time in the metropolitan area or county where recruited 
(3) primary communication in English 
(4) previous direct or indirect exposure to law enforcement 
(5) has covid vaccination and applicable boosters (self-report, not required to show proof) 
 
Exclusion Criteria:  
(1) inability to provide informed consent; and  
(2) active COVID-19 symptoms per CDC.56  

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(3) Parolees currently living in a court ordered treatment center as part of parole and/or individuals 
otherwise meeting the definition of a prisoner 
 
We include participants with prior COVID-19 vaccination (completed series) or recent COVID-19 
infection in past 3 months given that they may be important change agents. We will remove the 
estimated numbers (n=160) who are vaccinated/recent infection from our primary analysis if there are 
no future vaccine boosters or new vaccines required (i.e., new variant). Candidate participants with 
COVID-19 symptoms will be referred for free testing at existing partners for each of the study sites. 
 
Sex as a Biologic Variable. Both sexes and all genders will be included in this study with exploratory 
analyses to determine any differences in intervention effects. 
 
 
STUDY VISIT PROCEDURES  
Study procedures include:  
1) Informed consent, locator form 
2) Baseline survey with network elicitation  
3) Randomization  
4) Motivational or Education intervention 
(approximately 3 hours)  
5) Booster/Communication 30-day ±7 days 
phone follow-up  
6) 3-month follow-up phone survey ±7 days to 
assess participant and network COVID-19 
testing/vaccination history  
 
Eligible candidate study participants will 
undergo written informed consent. Following 
consent, study participants will complete a 
survey (Baseline Assessment) includes 
variables of interest and the social network 
inventory. Randomization will occur following 
the survey, and participants will be assigned 
to one of two concurrent Motivational or 
Educational group-level sessions. Sessions will be held weekly, also with availability, in the evening or 
on weekends. Study staff will be notified of group allocation and bring study participants to the 
appropriate group session/intervention rooms.  
 
Between 8-10 study participants will participate in each intervention room and the interventions (either 
Motivational or Educational) co-facilitated by both trained research staff and community members. 
Please note that community members will either be part of an IRB approved study site or will have an 
Individual Investigator Agreement with approved reliance on the University of Chicago IRB. All study 
sites have approved COVID-19 infection control plans for research participant studies and guidance 
updates will be continuously monitored by multi-PI Schneider. The entire study visit including group 
intervention will take 4-5 hours. All participants (irrespective of study arm) will receive referral 
information for COVID-19 testing/vaccination. The group sessions may be conducted in-person or 
virtually depending on changes in the COVID-19 response.   
 
 
Informed Consent: Eligible participants will be asked to participate in written informed consent using 
either a paper consent or electronic consent. The following consent processes applies to both the 
study consent form and the release of information form.   
 
Analysis            t=30 days    Allocation(t=0)  
Assessed for Enrollment (n=800) 
Informed Consent and Baseline Data 
Collected (t=0) 
1:1 Randomization (n=800) 
Motivational Intervention Condition 
(n=400) 
Mini-Booster and survey 
Motivation intervention participants (n=400) 
and participant network members (n ̴ 1,600)  
Education Condition (n=400) 
COVID-19 education booster and survey 
Education participant (n=400) and participant 
network members (n ̴ 1,600) 
Consort Diagram of C3 Study 
 

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In-person Consent Methods: 
 
Paper Consent: 
A study team will provide the subject with a copy of the study consent. The consent document will be 
reviewed and any questions regarding the study will be answered by the study team. If the subject 
agrees to participate in the study, they will be instructed to sign the consent form. Staff will also sign 
and the subject will be provided with a final signed copy. A signed copy will be stored by the study 
team. 
 
Electronic Consent: 
Consent may be obtained in-person electronically via RedCAP. Study staff can present the consent to 
the subject on the tablet or on paper depending upon subject preference. The consent document will be 
reviewed and any questions regarding the study will be answered by the study team. If the subject 
agrees to participate in the study, the subject will be instructed to sign the consent form via RedCAP e-
consent signature. Staff will also sign the consent form and update the RedCAP link to provide the 
subject with a final, signed version of the consent form via email. The final signed consent document 
will be stored in RedCAP. 
 
Remote Consent Methods:  
 
Written consent signature using paper mail: 
If the subject agrees to participate in the study, a paper consent will be mailed to the subject.  The 
subject will be instructed to contact the study team once it is received.  The consent will then be 
discussed in full over the phone and any questions will be answered. If the subject wishes to 
participate, he/she will sign the consent, then send back to the study team via direct mail. After the 
signed consent form is received, staff will also sign the consent form and send the subject a final, 
signed version via direct mail. A signed copy will be stored by the study team. 
 
Electronic Consent Remote using RedCAP: 
Remote consent would be conducted via telephone or video call (with preference being video call 
whenever possible) using a link through REDCap.  A link to the to the consent in RedCAP will be sent 
to the subject via text and/or email. The study staff will discuss the consent form with the subject, and 
any questions regarding the study will be answered by the study team.  The subject's identity will be 
verified as described below.  If the subject agrees to participate in the study, he/she will be instructed to 
sign the consent form via RedCAP e-consent signature. Staff will also sign the consent form and 
update the RedCAP link in order to provide the subject with a final, signed version of the consent form. 
The final signed consent document will be stored in RedCAP.   
 
The study team will do due diligence to verify the subject’s identity before beginning the consent 
process. Traditional means of verifying subject identity may be challenging in this subject population. 
Most will not be patients with local medical records to reference, some will not have formal state IDs, 
some may not have permanent residence, etc. Strict enforcement of state ID could disenfranchise 
those who may well be the most important group to reach and the very population that needs to be 
studied. Subject identity will be verified using the following methods, in the following order of 
requirement: 
1) 
Visually display a driver’s license or state ID 
2) 
Visually display an alternative photo ID (employee ID, school ID, etc) in combination with a 
piece of mail displaying the subject’s name.  
3) 
Visually display an alternative photo ID (employee ID, school ID, etc) alone 

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4) 
Visually display one of the following pieces of mail with subject’s name and address: utility bill, 
cellphone bill, correspondence from the secretary of state or other government organization 
5) 
Visually displaying any piece of mail listing the subject’s name and address 
6) 
Asking the subject to verbally state their name 
 
 
Baseline Surveys: 
The Locator Form and Baseline Assessment is completed at the time of enrollment. These are 
completed electronically and may be done in person using a study laptop or remotely via telephone or 
video call. 
 
Randomization. Study participants will be randomized to receive the Education or Motivational 
intervention at a 1:1 ratio. Randomization will be performed at the participant level, meaning that in 
general, participants within a site will be assigned to different groups. Randomization will be stratified 
by site as well as by key participant characteristics such as prior infection/vaccination, to ensure 
balance. Random assignments will be provided via a web-based API, with the touchpads programmed 
to retrieve an assignment at the appropriate time and deliver message to staff so they can direct the 
participant to the appropriate room. 
 
C3 Intervention: COVID-19 Testing and Vaccination Network Intervention Condition. Study 
participants randomized to the Motivational Intervention will receive the intervention using a social 
network diffusion approach. The Motivational intervention will be based upon a previous workshop 
divided into four learning and practice modules (Table 2 below).  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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The first module introduces COVID-19 prevention (testing and vaccination) in an interactive Fact or 
Myth activity that will provide an overview for understanding the implications of COVID-19 tailored to 
the specific audience.  
 
C3 Intervention Components adapted from RADx-UP Phase I and PrEPChicago. 
Strategy 
Content 
Duration 
Intervention Strategy 
Source(s) 
Fact or Myth session 
with sub-group role-
play 
COVID-19 prevention Fact or 
Myth session 
1) different types of tests and 
vaccines; 2) technology, clinical 
development and effectiveness; 
3) vaccine dosing 
administration and relationship 
to prior COVID-19 infection; 4) 
potential side-effects; and 5) 
how to access it. 
45 minutes 
PrEPChicago/RADx-UP 
Phase I 
Situation Appropriate 
COVID-19 Prevention  
Knowing the network member’s 
COVID-19 history (ie. prior 
infection, recent exposure). 
Discussion of indications for 
testing (ie. COVID-19 
symptoms, known exposure) 
and vaccination post-infection. 
Testimonials around 
misinformation, correction and 
discussion. 
45 minutes 
RADx-UP Phase I 
Empowering 
Appropriate COVID-19 
Prevention 
Reasons for vaccination and 
group-selected topics of 
discussion 
(1) prompting individuals to 
generate and verbalize their 
own reasons for testing and 
vaccination and (2) allowing 
individuals to choose testing 
and vaccination topics most 
relevant  
30 minutes 
Project Voice/RADx-UP 
Phase I 
Network engagement 
and Motivational 
Interviewing 
Effective Delivery of Information 
and MI strategy discussion 
(1) how the conversation will be 
raised, (2) how potential 
barriers to testing and 
vaccination will be addressed, 
(3) how network members can 
be assisted to make a visit to a 
COVID-19 services site, and (4) 
what sort of follow-up is 
required to motivate network 
members who have yet to be 
tested/vaccinated after earlier 
conversations.  
60 minutes 
PrEPChicago/RADx-UP 
Phase I 
Table 2.  Motivation Intervention 

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The second module builds upon RADx-UP Phase I to provide situation-appropriate recommendations 
given the diversity of COVID-19 spaces network members find themselves in (previously infected, 
congregate setting, recently exposed etc.). This module also utilizes video testimonials developed in 
RADx-UP Phase I that feature community members with lived testing and vaccination experiences. The 
videos will be viewed in a group setting using a large computer or TV monitor. A list of videos will be 
provided with descriptive information about the factual content they present. Content will be updated in 
real time as testing/vaccination recommendations change, and these changes will also be matched to 
outcome assessment.  
 
The third module will ensure participants actively engage with COVID-19 prevention information and 
content. We will facilitate an empowerment process that will direct participants to choose testing and/or 
vaccination topics that they would like to consider (e.g., prevent health risks, protect others from 
infection, vaccine safety, future regret) and then prompt them to generate and verbalize their own 
reasons for testing/vaccination based on those topics.  
 
The fourth module aims to develop the social network motivation strategy which will be reinforced by 
interventionists who have completed motivational interviewing training. Through role-playing scenarios, 
participants will rehearse conversational strategies for addressing some of these personal barriers and 
develop their ability to deliver information in effective and productive ways. Walkthrough and scenario 
play will be strategies to assist with planning regarding: 1) how the conversation will be raised; 2) how 
potential barriers to testing/vaccination will be addressed; 3) how network members can be assisted to 
make a testing/vaccine site visit; and 4) what sort of follow-up is required to motivate network members 
who have yet to engage in COVID-19 prevention after earlier conversations. This strategy develops 
participants’ communication skills in order to increase their effectiveness as COVID-19 testing/vaccine 
change agents.62  
 
 
COVID-19 Prevention Education Intervention.  
The Education condition will include COVID-19 prevention messaging and an interactive activity 
reinforcing the messages. RADx-UP Phase I testimonial video messages were developed based on 
previous focus group data, featuring community advocates recruited from those focus groups and have 
undergone adaptation and have been vetted by the COVID-19 CAB. 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. An active control group, as opposed to clinic standard of care 
(i.e., provision of limited COVID-19 information and/or materials) was selected for C3 for several 
reasons. First, provision of standard of care would not control for the attention that study participants 
will receive from study staff as well as the time to deliver the intervention (both Motivational and 
Education conditions will take 4 hours). In addition, there is an ethical mandate to provide the best 
tailored control available in the context of ongoing COVID-19 morbidity and mortality. Finally, 
community feedback and CAB input clearly delineates the requirement that community members are 
receiving meaningful education and COVID-19 prevention engagement activities as part of this 
research and not “substandard care”. 
 
 
Mini-Booster Communication Session at 30-day follow-up 
Additional contact with project staff following initial interventions is an important component of sustained 
behavior change and study engagement. For this reason, staff trainers will maintain contact with 
participants after the initial training through a telephone check-in referred to as a “mini-booster”, which 

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the C3 team has utilized successfully in previous work.1-3 A staff member will conduct the mini-booster 
with each participant, lasting 10-20 minutes.  
 
Each mini-booster consists of four components: 1) collecting information about specific network 
members that the participant has engaged with about testing/vaccination (both Education/Motivational 
arm); 2) devising personalized conversational strategies for approaching these network members (C3); 
3) troubleshooting communication barriers (C3); and 4) setting personal outreach goals (C3). The 
Education condition will also have a 30-day follow-up conversation and review of any questions that 
may come up. Measurement of testing/vaccine barriers for participants and participants’ report on 
network members will be collected during the booster session for both Motivational and Education 
conditions. The same staff member who provided the initial intervention will conduct the booster with a 
given participant in order to continue rapport building. 
 
Subject Compensation. Compensation will be provided for study participation- up to $200 will be 
provided for study participation and all participants will receive snacks/refreshments during the 
Education and Motivational arm sessions. Compensation will be provided as follows: 
1) $150 will be provided for completing the first study interaction (i.e., consent, ROI, Education or 
Motivation group session, baseline survey and short locator form); 
2) $25 for completing the second study interaction (i.e., short phone booster session and second 
survey 30 days later); and  
3) $25 for completing the third study interaction (i.e., final survey 90 days post enrollment). 
Payments will be in cash, gift cards or e-payments such as CashApp, PayPal or Venmo. 
Staff Training and Fidelity. Site teams consisting of existing research staff and community facilitators 
will deliver the study conditions. Separate staff will deliver the Educational and Motivational intervention 
group sessions (described below). Site teams will undergo two full day training sessions that include 
study procedures and group session activities. All research and community facilitators will undergo 
initial motivational interviewer training with a certified MINT trainer on core motivational interviewing 
(MI) principals and then monthly follow-up sessions providing clear and objective feedback. In addition, 
research staff will be trained to have capacity to support multiple participants simultaneously in the self-
administered portion of the study visit: clarifying any survey items, troubleshooting any technology/data 
collection issues, and transitioning to interviewer administered for people with limited literacy. Fidelity to 
Educational and Motivational intervention conditions will be evaluated using a self-monitoring fidelity 
check-list for interventionists. A sample of 10% of the sessions will be recorded (video and/or audio) for 
quality improvement purposes and reviewed by project managers/PIs. These recordings may be shared 
amongst the respective site-specific study team, but will not be shared outside of the subject’s study 
site). Subjects will be asked whether they are willing to have the session recorded and can indicate yes 
or no on the study consent form.  
 
Primary Outcomes.  Two primary outcomes will be assessed at the level of the participant: the 
probability of receiving at least one 1) test and 2) vaccination dose within 3 months of baseline. 
Outcomes will be ascertained specifically by testing/vaccine registry data held by city and state held 
vaccine registries (Letters, Huang, Arwady, Zohoori).  Study participants will sign release of information 
forms, as in RADx-UP Phase I, in order for study staff to obtain 3-month testing/vaccination disposition 
statuses. Covid testing/vaccination status may also be provided by subject showing a copy of their 
covid testing result and/or vaccination information.  This may be provided in person, shown during a 
video call, emailed or texted as a picture.  Finally, study staff will reach out to all study participants 
(N=800) at 3 months following baseline to collect information on testing and vaccination uptake among 
study participants and barriers and facilitators for both network members and study participants. During 

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this assessment, information on situation appropriate testing will be collected to better understand the 
circumstances and context of testing. At the time of this writing, situation appropriate testing includes 
testing if symptomatic, if exposed to someone with COVID-19 infection and if entering a congregate 
living setting. Only participants reporting symptoms, exposure, and/or congregate housing will be 
included in the primary testing outcome analysis; post-hoc analysis will include all participants tested 
irrespective of the situation/context. 
 
Secondary Outcome. Two secondary outcomes will be assessed at the level of the secondary 
subjects (network member connected to primary participant): the probability of receiving at least one 1) 
test and 2) vaccination dose within 3 months of baseline. Network member information, including 
identifying information will be collected during the baseline assessment through specialized network 
canvas software (described above). The secondary outcome will be determined based upon self-report 
from participants during the 30 and 90-day follow-up surveys. Note that this information is collected 
based asking the study subject whether the social network contact underwent these activities and not 
from contact with or medical record data collection of the social network member. Analyses for our 
secondary outcome will account for variability in network size across individuals. 
 
Other Variables for Analysis.  Additional variables for analysis will be obtained from the JCOIN 
Community Measures database that is stored in the JCOIN Data Core and which the PIs have 
access.69,70 These measures have been collected from other validated scales and items and include 
items from the Phenx toolkit64 including vaccine hesitancy. Measures to be included in analyses include 
the following: age, race, ethnicity, gender, sex at birth, mental health (e.g., PHQ-9), symptoms of 
anxiety/depression, and CLI history; as well as COVID-19 knowledge, testing history, 
infection/treatment history, access to medical care, substance use history, prevention behaviors, 
attitudes/beliefs about prevention efficacy, vaccine knowledge/attitudes and vaccination practices (e.g., 
flu vaccination), medical mistrust, perceptions about COVID-19 risk and severity, prior contact by 
contact tracer, experiences of racism, fears about immigration status, housing status and household 
composition, food insecurity, employment/occupation, mobility, experience of violence, workplace 
resources, PPE availability, and known COVID-19 contact. Social network size, density, social control, 
influence and trust will be from the Community Measures database and collection will be facilitated by 
NC.63  
 
Primary and Secondary Outcome Analysis. Two sets of analyses will be performed. The first will 
focus on testing and vaccination among participants and the second will focus on testing and 
vaccination among the networks of participants. Testing and vaccination will be analyzed as separate 
outcomes throughout. The primary outcome analysis will compare the probability of testing and the 
probability of vaccination among participants assigned to Educational vs. Motivational intervention. 
Secondary analyses will compare the total number of network members tested and vaccinated and the 
probability of testing/ vaccination among network members of participants assigned to Educational vs. 
Motivational intervention (Aim 1). All analyses will use generalized linear models with link functions 
based on the distribution of the outcome (logistic or log binomial for binary outcomes; negative binomial 
regression for count outcomes) and random effects as appropriate to account for clustering of network 
members within participants. The initial analysis will include an indicator for intervention assignment as 
the only independent variable and will not adjust for covariates since the randomization should ensure 
comparability between the groups on measured and unmeasured confounders, though group 
characteristics at baseline will be inspected visually for imbalances (Aim 1a). We will then incorporate 
participant (e.g., mental health, early adopter status) and network level (e.g., network thresholds, 
density) covariates to improve the precision of the estimates and to identify sociodemographic and 
network characteristics associated with differences in testing and vaccination yield. In addition, we will 
explore interactions between intervention group (Education vs. Motivational intervention) and 
participant characteristics to determine whether the intervention is more effective in certain groups than 

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others (Aim 1b). Because we will likely have limited power to detect small to medium sized interaction 
effects in subgroup analyses, we will consider these analyses exploratory, with the goal of generating 
insights to guide future work. Partial pooling within a Bayesian estimation framework71 will be used to 
avoid bias and address the issue of multiple comparisons when testing interactions. We will also 
include an indicator for time trends to control for potential changes in testing recommendations, vaccine 
availability, infection rates, or other factors that could impact testing and vaccination outcomes over the 
study. The small number of sites precludes inclusion of a site-level random effect so site will be 
included as a fixed effect to account for between site differences in participant characteristics and local 
epidemic trends. The clustered version of the robust (i.e., sandwich) variance estimator will be used in 
all analyses to ensure correct inference even in the presence of other sources of within-cluster 
correlation in the data not captured in the model.72 For the participant outcomes, the probability of 
testing and vaccination (binary outcomes) will be modeled using logistic or log binomial regression 
based on model fit and consistency with model assumptions. The total number of tested/vaccinated 
network members will be modeled using negative binomial regression with total network size as an 
offset to account for differences among participants in the number of named network members.73 A 
second analysis will treat each network member as an observation (tested/vaccinated or not) and will 
model the likelihood that network members are tested/vaccinated using logistic regression with random 
effects at the level of the study participant. We will also include a fixed effect for site. This approach will 
also allow us to examine whether characteristics of the network members (e.g., trust, social influence 
and social control within a dyad) are associated with probability of testing/vaccination. 
 
 
Power Calculations. Statistical power for Aim 1 was computed across a range of plausible effect sizes 
and outcome prevalence estimates. Power was estimated conservatively, assuming that of the 800 
total participants and their network members, 10% would meet the current CDC recommended criteria 
for testing (recent exposure, symptoms, or congregate housing) and thus the sample size for the 
primary testing outcome was estimated at N=80 eligible participants. We assumed that 30% would 
previously have been fully vaccinated or infected with COVID-19 in the past 6 months, resulting in an 
analytic sample size for vaccination outcomes of N=560 participants and their network members. 
Power may change depending on the evolution of the pandemic (e.g., changes in infection rates, 
prevalence of variants, and/or local public health guidance regarding testing and booster vaccine 
recommendations), and will be higher with broader testing eligibility, higher outcome prevalence, and 
for analyses treating each network member as a separate observation. For each outcome, we 
computed minimum detectable effect sizes given estimated rates of testing and vaccination in the 
control group. We estimated 3-month testing rates among those eligible for testing of 10% in the control 
group. Based on our ongoing influenza vaccination work, as a starting point for calculations we 
estimated 3-month vaccination rates among study participants and their network members of 
approximately 30%. All calculations were conducted in Stata/SE version 15.1 with alpha=0.05, two-
sided tests, and a 2:1 ratio of randomization to the intervention vs. control group. For participant testing 
(primary outcome 1), with a sample size of 80 eligible participants and control group testing prevalence 
of 10%, we would have 80% power to detect differences of 28 percentage points or more (proportion 
tested in the intervention group ≥38%. For participant vaccination (primary outcome 2), with a sample 
size of 560 and vaccination prevalence of 30% in the control group, we would have 80% power to 
detect differences of ≥12 percentage points (proportion vaccinated in the intervention group ≥42%). For 
evaluating interaction effects (Aim 1b), with a sample size of 560 we would have >80% power to detect 
an interaction between intervention assignment and an evenly distributed binary covariate (50% in 
group A and 50% in group B) when vaccination prevalence in the control group is 30% and the 
intervention increases vaccination to 40% in group A and 69% in group B (e.g., the intervention is more 
effective in group B). For the participant testing outcome, we will have limited power to detect 
interaction effects except those of very large magnitude, but will explore differences in testing across 

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subgroups to guide future work.  For the network outcomes (secondary outcome 1&2), we assume that 
the number of network members tested/vaccinated follows a negative binomial distribution with an over 
dispersion parameter equal to 2 to reflect variability among participants in terms of testing and 
vaccination referrals. For network testing, with a sample size of 800 participants (with an average of 2-3 
named network members per participant), we would have ≥80% power to test the null hypothesis of no 
difference between groups if the mean number of tested network members per participant is 0.12 in the 
control group and 0.25 in the intervention group (i.e., the intervention increases the proportion of 
participants with any network members tested from 10% to 18% and the proportion with >2 network 
members tested from 0.2% to 1.3%). For network vaccination, with a sample size of 560, we would 
have >80% power to test the null hypothesis of no difference between groups if the mean number of 
vaccinated network members per participant is 0.51 in the control and 0.92 in the intervention group, 
which reflects a scenario where the intervention increases the proportion of participants with any 
network members vaccinated from 30% to 41% and the proportion with more than 2 network members 
vaccinated from 5.1% to 12.1%. Thus, we will have sufficient power to detect effect sizes consistent 
with our previous work.  
Attrition and missing data. All participants enrolled in the study will be included in our analyses; since 
the primary outcome will be measured based on testing/vaccine registry data we are confident that 
there will be limited missing data given that this type of registry has considerable resources to support it 
and is required for the EUA status. As an additional precaution, all participants will be interviewed to 
assess for testing/vaccination status among themselves and network members at 3 months. Thus, we 
anticipate very little missing outcome data. Any missing data will be addressed using multiple 
imputation74 or by using a fully Bayesian approach to estimate the model75 (in which missing data are 
essentially treated as additional unknown parameters). 
POTENTIAL RISKS AND BENEFITS TO SUBJECTS 
In general, protection against risk to participants will be accomplished through thorough training of 
research staff; careful orientation of potential participants as to the nature, risk, and benefits of the 
research; strict adherence to study protocols; and regular surveillance for adverse events. Additionally, 
this study will receive an NIH Certificate of Confidentiality to further protect information shared. 
• The following steps will be taken to protect the confidentiality of all data generated and collected 
throughout the course of the study: 
• Data access will be limited to a specified group of programmers and researchers identified as 
study personnel. An audit trail will be maintained to track all user-access to the data. 
• All study investigators and research team personnel will be trained in the importance of 
confidentiality and trained to follow all rules related to handling confidential data.  
• All data sets resulting from this study will be kept exclusively in the BSD CRI system at the 
University of Chicago, access to which requires administrative approval and password. The 
internal server is encrypted at the storage, backup, and sharing levels, thereby maximizing 
protections against breaches of confidentiality. 
• The research team will not be permitted to copy the raw data or to transmit the raw data other than 
through a secure server connection. 
• Results of the study will be reported only in the aggregate and without other identifiable data, with 
attention to issues of statistical disclosure. 
 
Protection of privacy. All study procedures will be performed in quiet, private spaces to ensure 
confidentiality. If covid test results and/or vaccine status is communicated via email or text picture using 
a cell phone, this communication would occur with the subject’s site study personnel only. The 
testing/vaccination data would be recorded and the email/text picture would be deleted.  The images 

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are not retained or shared.   
 
Protection against psychological discomfort. Survey questions may touch on potentially sensitive topics. 
Participants will be informed of this possibility through assent/consent procedures and they will be 
reminded that they may skip questions or discontinue participation altogether. If a participant expresses 
distress directly to the research team, they will be provided the name and contact information of several 
licensed behavioral health providers on our research team and other local resources as needed.  
Protection against testing risks. Testing Procedures and Infection Control Measures. All COVID-19 
testing procedures will take place according to SOPs at each of the participating partnering health 
departments and clinics. These procedures ensure that appropriate infection control measures, a 
COVID-19 screener (Appendix C), counseling, including quarantine and isolation procedures, masking 
and results disclosures are provided in accordance to the current standard of care and CDC guidelines. 
Monetary, food, other tangible supports, and/or linkage to further medical evaluation and will be 
provided for individuals who test positive and require resources to adhere to quarantine and social 
distancing requirements. Performance of surveys and interviews will abide by social distancing 
guidelines. 
 
Benefits: The potential benefits of this research far outweighs the risks. For individual participants, 
benefits include COVID-19 testing/vaccination information and reduced likelihood of COVID-19 severe 
complications and hospitalizations, with provision of financial and other tangible resources for 
quarantine and isolation as well as linkage to medical care if necessary. Possible risks (i.e. discomfort 
answering questions, potential confidentiality breaches, stigma) are outweighed by the new knowledge 
gained as described above and the direct clinical benefits and supportive services to participants. 
  
DATA STORAGE AND SHARING 
We will take several steps to ensure the security of the identifiers and data collected for this study. All 
data will be collected using dedicated laptops purchased by the project and configured and certified by 
BSDIS to meet their requirements for portable computers (e.g., timed log-out, whole-disk encryption, 
use of BigFix and antivirus software, etc.). Data will be entered into REDCap (web-based application 
hosted by the CRI at the University of Chicago).  This data will be maintained on a HIPAA compliant, 
secure server hosted at the University of Chicago. 
 
The identifiers of social network members (first name and last initial only) will be uploaded and stored in 
a separate, dedicated file share held on a secure, HIPAA compliant server at the University of Chicago, 
accessible only by the data analyst team who will be located at the University of Chicago and NORC. 
Social network identifiers will not be shared outside of the data analyst team and will not be accessible 
to the wider study team. The data analyst team will monitor the incoming files to ensure 
confidentiality.  Social network identifiers are used to analyze whether the study interventions affect the 
study subject and their social network members’ likelihood of becoming vaccinated and/or testing for 
COVID (based on the study subject’s survey response). Once this analysis has been completed, all 
files containing network member identifiers will be destroyed. 
 
Upon study termination, participant identifiers will be removed from the study dataset. All recordings of 
study trainings will be destroyed upon study termination. The de-identified study data may be maintained 
indefinitely at the University of Chicago.  
 
UAMS will destroy any raw data received from Arkansas Department of Health upon study completion. 
 
Data Transfer: 

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Before any data transfer, the University of Chicago will encrypt the data both at rest and in transit to 
provide a high level of security of sending and receiving file transfers. The encrypted data products will 
be securely uploaded to a server using a cyberinfrastructure service such as Globus 
(https://www.globus.org/) via the Biological Science Division Information Services (BSDIS). This will 
ensure high security features that meet authentication and authorization standards for sensitive data 
containing protected health information. Additionally, data management and transferring services for 
personally identifiable data will be with a High Assurance or HIPAA BAA subscription. If an institution is 
responsible to provide data (incoming), they will be responsible for encryption.  
 
Northwestern University 
Northwestern (NWU) will assist with data analysis for the planned qualitative interviews and survey data. 
NWU will receive text transcripts from interviews as well as survey data for analysis.  These data may 
contain dates and zip codes but will not contain any other identifying information (such as names). Shared 
data will be linked to the subject’s unique ID number, but the key will be kept by the University of Chicago 
team and not shared. 
 
NIH and DCRI  
The Duke Clinical Research Institute (DCRI) has been chosen by the National Institute of Health (NIH) 
to serve as the data coordinating center for all of the RADx-UP study centers (note, outside of our multi-
center studies, there are other institutions who have received funding from the NIH to conduct related 
research under the RADx funding initiative). A limited study data set (includes zip codes and dates) will 
be shared with DCRI to link area level data sets and to add context to the socioeconomic, environmental, 
and public health outcomes in larger data sets.  DCRI will maintain a database that can be shared with 
RADx-UP consortium members (those who are conducting the RADx-UP studies) for future research. 
The consortium database will include zip codes and dates and will be maintained by DCRI indefinitely.  
RADx-UP consortium members will be required to apply to use this dataset.  All data shared for future 
research in this manner would be de-identified and could be used indefinitely. 
 
DCRI will also transfer a de-identified study data set to the NIH for purposes for future research in keeping 
with the NIH’s policy.  All data shared for future research in this manner would be de-identified and could 
be used indefinitely. 
  
 
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