NCT04743908: C3

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

Completed NA Results posted Last updated 10 October 2024

What this trial tests

NA trial testing Social Network Strategy + COVID-19 messaging in Covid19 in 1,328 participants. Completed in 31 December 2022.

Timeline

29 April 2021

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	University of Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,328
Start date	29 April 2021
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Social Network Strategy + COVID-19 messaging

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

University of Chicago

Who can join

15 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Number of Tests Among Network Members Referred for COVID Testing (Network Tested). Primary · 21 days from initial study visit for each participant

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

Group	Value	95% CI
Social Network Strategy (SNS Condition)	444
Social Network Strategy + Messaging	437
Social Network Strategy (SNS Condition)	196
Social Network Strategy + Messaging	206
Social Network Strategy (SNS Condition)	21
Social Network Strategy + Messaging	24

Total Number of Vaccinations Among Study Participants Given COVID Vaccine Information (Number Vaccinated) Primary · 21 days from initial study visit for each participant

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

Group	Value	95% CI
Social Network Strategy (SNS Condition)	18
Social Network Strategy + Messaging	27
Social Network Strategy (SNS Condition)	81
Social Network Strategy + Messaging	94
Social Network Strategy (SNS Condition)	83
Social Network Strategy + Messaging	75

Adverse events — posted to ClinicalTrials.gov

Time frame: 21 days from initial study visit for each participant. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Social Network Strategy (SNS Condition)

Serious: 1/661 (0%)

Deaths: 1/661

Social Network Strategy + Messaging

Serious: 0/667 (0%)

Deaths: 2/667

Serious adverse events (1 terms)

Reaction	System	Social Network Strategy (S…	Social Network Strategy + …
Hospitalization	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Hospitalization.

Data from ClinicalTrials.gov NCT04743908 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. COVID-19 prevention behaviors are congruent within social networks of disenfranchised Hispanic and criminal legal involved community members.
   Umutoni V, Bhavan K, Zaller N, Knopf A, et al · · 2025 · PMID 40883406 · DOI 10.1038/s41598-025-16623-z