Community Network-driven COVID-19 Testing and Vaccination of Vulnerable Populations in the Central US

NCT04743908 | Completed Results

• 2 other identifiers: IRB20-14943UG1DA050066-02S1
• Study Type: interventional
• Target: 1,328
• Locations: 1 country
• Sites: 1

Brief Summary

This C3 project, Community network-driven COVID-19 testing of vulnerable populations in the Central US, will implement and evaluate a COVID-19 testing and vaccination approach that combines an evidence-based Social Network Testing Strategy (SNS) with community developed COVID-19 public health messages (SNS+). C3 will engage two disenfranchised populations across rural and urban sites in states across the Central US (Texas (TX), Louisiana (LA), Arkansas (AR), Indiana (IN), Illinois (IL)). C3 leverages NIDA's Justice Community Opioid Innovation Network (JCOIN), the PIs' extensive community located COVID-19 testing programs, and a network of established community partnerships. The collaborative community-academic partnerships, research and engagement infrastructure, and team's leadership across JCOIN will ensure that C3 can rapidly recruit, enroll and test most disenfranchised community members, (n=2400) and through this process, accelerate any forthcoming COVID-19 public health prevention interventions. C3 focuses on two communities most impacted by COVID-19: 1) Criminal justice involved (CJI) - non-incarcerated people with previous history of arrest/jail/prison, probation/parole, drug-court attendance, witnessed or experienced a negative interaction with police or law enforcement; and 2) Low-income Latinx - community members at 250% or below Federal Poverty Level. Both of these diverse populations, and the overlap between them, have some of the highest rates of COVID-19 infection and death in the United States. Messaging that affirms individual agency and corrects misinformation, combined with accessible and acceptable testing, is required to accelerate COVID-19 prevention for these populations.Using a two-arm randomized controlled trial design, participants will be enrolled into the Social Network testing Strategy (SNS) arm (involves social networking referrals only) or the Social Network testing Strategy with COVID-19 prevention messages (SNS+) messaging arm. The latter includes affirmation/misinformation correction messaging (discussion tools and coaching). SNS and SNS+messaging arms will both include an initial group of index study participants who will refer their network members into the study and the process will repeat itself one more time for a total of 3 waves. Indexes will refer network members (1st degree) and then those network members will refer one more round (2nd degree).

Conditions

Covid19

Keywords

Criminal Justice Involved; Latinx; Social Network Strategy

Outcome Measures

Primary Outcomes (2)

• Total Number of Tests Among Network Members Referred for COVID Testing (Network Tested).

  Network tested is measured at the participant level by the number of network members that are tested through the SNS.

  21 days from initial study visit for each participant

• Total Number of Vaccinations Among Study Participants Given COVID Vaccine Information (Number Vaccinated)

  Number vaccinated is measured at the participant level by the number of study participants that are vaccinated through the SNS.

  21 days from initial study visit for each participant

Study Arms (2)

Social Network Strategy (SNS Condition)

NO INTERVENTION

Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". 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 will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared.

Social Network Strategy + Messaging

EXPERIMENTAL

Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walk through and scenario play will be strategies to assist with planning regarding: (1) how the conversation will be raised, (2) how potential barriers to testing will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared. Finally, community developed COVID-19 public health messages will be shared in the participant's preferred language.

Other: Social Network Strategy + COVID-19 messaging

Interventions

Social Network Strategy + COVID-19 messaging OTHER

Contextually adapted and theory-driven messages - misinformation correction and self-affirmation - to increase awareness, self-efficacy and community engagement in our adapted Social Network testing Strategy (SNS). SNS is an evidence-based testing intervention that has been widely used in multiple settings with marginalized individuals (ie substance-users) who facilitate the recruitment of their social contacts into testing services.

Social Network Strategy + Messaging

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Index community members will be:
• years or older (15-28 years old at University of Indiana site);
• spend majority of their time in the metropolitan area or county where recruited;
• have access to a phone for 21-day follow-up call; and
• primary communication in English or Spanish (based on site; Spanish language for Howard Brown/Project Vida and UTSW) AND at least one of the following: (i) ever had CJI (operationalized as any jail, prison, arrest, parole (completed), probation, drug court); (ii) ever had negative interaction with police or law enforcement that did not lead to an arrest or jail/prison time (operationalized as ever stopped, searched, physically or verbally abused, or had another negative interaction with police or law enforcement); (iii) ever witnessed a negative interaction with police or law enforcement (iv) lower-income Latinx (operationalized as at or below 250% of FPL) (Not applicable for University of Indiana).
• Social network referrals will be:
• linked to the index as a "friend, family, coworker or someone you spend time with on a regular basis";
• visit within two weeks of index visit;
• years or older;
• spend the majority of their time in the metropolitan area or county where recruited;
• have access to a phone for 21-day follow-up call; and
• primary communication in English or Spanish.

You may not qualify if:

• inability to provide informed consent; and
• active COVID-19 symptoms per the Centers for Disease Control and Prevention (CDC). Participants with COVID-19 symptoms will be referred for free testing at existing partners for each of the study sites.
• currently on parole
• for the University of Indiana site, currently in foster care, on house arrest, on probation, detained at a federal facility or had a police encounter during which the officer(s) either asked for some form of identification and/or issued a traffic ticket, but did not have other CJI involvement.

Sponsors & Collaborators

• University of Chicago: lead
• Howard Brown Health Center: collaborator
• Community Action Place, Inc.: collaborator
• Indiana University: collaborator
• University of Arkansas: collaborator
• Better Community Development, Inc.: collaborator
• Capitol Area Reentry Program Inc.: collaborator
• University of Texas Southwestern Medical Center: collaborator
• San Jose State University: collaborator
• George Mason University: collaborator
• NORC at the University of Chicago: collaborator
• Northwestern University: collaborator
• Project Vida: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. John Schneider
• Organization: The University of Chicago

jschnei1@uchicago.edu

(773) 702-2453

Study Officials

• John Schneider, MD

  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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Using a two-arm randomized controlled trial design, participants will be enrolled into the SNS arm (involves social networking referrals only) or the SNS+messaging arm. The latter includes affirmation/misinformation correction messaging (discussion tools and coaching).

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 8, 2021
• Study Start: April 29, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)