Covid19
Conditions
Keywords
Criminal Justice Involved, Latinx, Social Network Strategy
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).
Interventions
OTHERSocial Network Strategy + COVID-19 messaging
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.
Sponsors
Howard Brown Health Center
Community Action Place, Inc.
Indiana University
University of Arkansas
Better Community Development, Inc.
Capitol Area Reentry Program Inc.
University of Texas Southwestern Medical Center
San Jose State University
George Mason University
NORC at the University of Chicago
Northwestern University
Project Vida
National Institute on Drug Abuse (NIDA)
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Index community members will be: 1. 18 years or older (15-28 years old at University of Indiana site); 2. spend majority of their time in the metropolitan area or county where recruited; 3. have access to a phone for 21-day follow-up call; and 4. 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: 1. linked to the index as a friend, family, coworker or someone you spend time with on a regular basis; 2. visit within two weeks of index visit; 3. 18 years or older; 4. spend the majority of their time in the metropolitan area or county where recruited; 5. have access to a phone for 21-day follow-up call; and 6. primary communication in English or Spanish.
Exclusion criteria
1. inability to provide informed consent; and 2. 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. 3. currently on parole 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Tests Among Network Members Referred for COVID Testing (Network Tested). | 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. |
| Total Number of Vaccinations Among Study Participants Given COVID Vaccine Information (Number Vaccinated) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Social Network Strategy (SNS Condition) 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. | 661 |
| Social Network Strategy + Messaging 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.
Social Network Strategy + COVID-19 messaging: 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. | 667 |
| Total | 1,328 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 181 | 180 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Social Network Strategy + Messaging | Total | Social Network Strategy (SNS Condition) |
|---|---|---|---|
| Age, Continuous | 39.7 years STANDARD_DEVIATION 14.4 | 39.6 years STANDARD_DEVIATION 14.6 | 39.5 years STANDARD_DEVIATION 14.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 217 Participants | 430 Participants | 213 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 429 Participants | 856 Participants | 427 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 Participants | 42 Participants | 21 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants | 19 Participants | 11 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 24 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 273 Participants | 529 Participants | 256 Participants |
| Race (NIH/OMB) More than one race | 24 Participants | 55 Participants | 31 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 114 Participants | 244 Participants | 130 Participants |
| Race (NIH/OMB) White | 237 Participants | 457 Participants | 220 Participants |
| Self-Reported COVID-19 Tests at Baseline Don't know, participant did not know if they been tested for COVID-19 prior to baseline. | 11 Participants | 17 Participants | 6 Participants |
| Self-Reported COVID-19 Tests at Baseline Missing | 2 Participants | 9 Participants | 7 Participants |
| Self-Reported COVID-19 Tests at Baseline No, participant had not been tested for COVID-19 prior to baseline. | 135 Participants | 253 Participants | 118 Participants |
| Self-Reported COVID-19 Tests at Baseline Yes, participant had been tested for COVID-19 prior to baseline. | 519 Participants | 1049 Participants | 530 Participants |
| Self-Reported COVID-19 Vaccination at Baseline Don't know, participant didn't know whether they had been vaccinated for COVID-19 | 10 Participants | 15 Participants | 5 Participants |
| Self-Reported COVID-19 Vaccination at Baseline Missing | 4 Participants | 8 Participants | 4 Participants |
| Self-Reported COVID-19 Vaccination at Baseline No, participant reported that they have not been vaccinated for COVID-19 | 182 Participants | 355 Participants | 173 Participants |
| Self-Reported COVID-19 Vaccination at Baseline Yes, participant reported that they have been vaccinated for COVID-19 | 471 Participants | 950 Participants | 479 Participants |
| Sex/Gender, Customized Assigned Sex at Birth Female | 328 Participants | 681 Participants | 353 Participants |
| Sex/Gender, Customized Assigned Sex at Birth Intersex | 1 Participants | 4 Participants | 3 Participants |
| Sex/Gender, Customized Assigned Sex at Birth Male | 329 Participants | 625 Participants | 296 Participants |
| Sex/Gender, Customized Assigned Sex at Birth Unknown, Refused, or Missing | 9 Participants | 18 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 661 | 2 / 667 |
| other Total, other adverse events | 0 / 661 | 0 / 667 |
| serious Total, serious adverse events | 1 / 661 | 0 / 667 |
Outcome results
Primary
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.
Time frame: 21 days from initial study visit for each participant
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Social Network Strategy (SNS Condition) | Total Number of Tests Among Network Members Referred for COVID Testing (Network Tested). | Tested | 444 Participants |
| Social Network Strategy (SNS Condition) | Total Number of Tests Among Network Members Referred for COVID Testing (Network Tested). | Not Tested | 196 Participants |
| Social Network Strategy (SNS Condition) | Total Number of Tests Among Network Members Referred for COVID Testing (Network Tested). | Missing Testing Data | 21 Participants |
| Social Network Strategy + Messaging | Total Number of Tests Among Network Members Referred for COVID Testing (Network Tested). | Tested | 437 Participants |
| Social Network Strategy + Messaging | Total Number of Tests Among Network Members Referred for COVID Testing (Network Tested). | Not Tested | 206 Participants |
| Social Network Strategy + Messaging | Total Number of Tests Among Network Members Referred for COVID Testing (Network Tested). | Missing Testing Data | 24 Participants |
Primary
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.
Time frame: 21 days from initial study visit for each participant
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Social Network Strategy (SNS Condition) | Total Number of Vaccinations Among Study Participants Given COVID Vaccine Information (Number Vaccinated) | Vaccinated | 18 Participants |
| Social Network Strategy (SNS Condition) | Total Number of Vaccinations Among Study Participants Given COVID Vaccine Information (Number Vaccinated) | Not Vaccinated | 81 Participants |
| Social Network Strategy (SNS Condition) | Total Number of Vaccinations Among Study Participants Given COVID Vaccine Information (Number Vaccinated) | Missing, Unknown, or Refused | 83 Participants |
| Social Network Strategy + Messaging | Total Number of Vaccinations Among Study Participants Given COVID Vaccine Information (Number Vaccinated) | Missing, Unknown, or Refused | 75 Participants |
| Social Network Strategy + Messaging | Total Number of Vaccinations Among Study Participants Given COVID Vaccine Information (Number Vaccinated) | Vaccinated | 27 Participants |
| Social Network Strategy + Messaging | Total Number of Vaccinations Among Study Participants Given COVID Vaccine Information (Number Vaccinated) | Not Vaccinated | 94 Participants |