Optimization of a New Adaptive Intervention to Increase COVID-19 Testing Among People at High Risk in an Urban Community
Phase: NA
Conditions: COVID-19 Testing
Sponsor: University of Illinois at Urbana-Champaign

Optimization of a New Adaptive Intervention to Increase COVID-19 Testing 
NCT04757298
Study Protocol
12/20/2020

 
 
 
IRB Study Application Form 
 
 
REVIEW CATEGORY:   
 
 Expedited Review  
 Full Board Review. 
 
1. 
PROJECT REVIEW 
 
 
 
 
New project: Optimization of a new adaptive intervention to increase COVID-19 
 
testing  among people at high risk in an urban community 
 
Resubmission project:   
 
 
Date of most recent previous review:  
 
 
2. 
DATA COLLECTION DATES 
01/04/2021 - 05/12/2022 
 
 
 
3. 
INVESTIGATOR(S) (copy and paste additional investigator names as needed): 
 
 
Investigator Name:  Ellen Benoit , PhD 
 
Department: Research, NJCRI  
Address:  393 Central Ave., Newark, NJ 07103 
 
Phone:  973-483-3444 x 281 
Email:  e.benoit@njcri.org 
 
 
Investigator Name:  Liliane C. Windsor, PhD 
 
 
Department: School of Social Work, University of Illinois at Urbana-Champaign 
Address:  1010 W. Nevada St., Urbana, IL 61801 
 
Phone:  217-300-1782 
Email:  lwindsor@illinois.edu 
 
 
4.        PROJECT TITLE/DESCRIPTION AND RECRUITMENT:   
 
Title: Optimization of a new adaptive intervention to increase COVID-19 testing among people at 
high risk in an urban community 
 
Little is known about the acceptability of COVID-19 testing in low-income and racial/ethnic minority 
neighborhoods, where residents experience increased barriers to prevention and treatment (e.g., 
unstable housing, higher risk jobs). In this study, community members and researchers will work 
together as partners with a community-based organization to test an intervention to increase 
COVID-19 testing and adherence to science-based COVID-19 treatment and prevention 
recommendations. We will adapt two cost-effective, evidence-based, and culturally appropriate 
interventions that have been successfully used to engage people in HIV testing and treatment. 
Navigation services (NS) increase HIV testing and adherence to treatment while addressing 
structural barriers that deter treatment engagement in high-risk communities. Brief counseling 

increases HIV treatment engagement. The study will assess the impact of these interventions on 
COVID-19 testing rates and on adherence to science-based guidelines to prevention and 
treatment. The study will also produce in-depth qualitative data identifying ways to overcome 
barriers for those who do not accept testing or adhere to NJ COVID-19 recommendations. 
This study is funded by the National Institutes of Health (NIH) as a supplement to our parent study 
optimizing Community Wise, an intervention to reduce substance use among formerly 
incarcerated men (R01 MD010629-01). The Community Wise optimization study is being 
conducted as community based participatory research (CBPR) with the Newark Community 
Collaborative Board (NCCB), a group of 20 community members, service providers, and 
researchers. NJCRI and the NCCB are the study’s community partners, connected through the 
Principal Investigators. Dr. Windsor is founder and chair of the NCCB; Dr. Benoit is employed by 
NJCRI and is an original NCCB member. For this study, the NCCB will continue to use CBPR to 
optimize an adaptive intervention that will take people through the COVID-19 continuum of 
prevention, care and treatment, starting with outreach, followed by testing, prevention intervention 
for those testing negative, and recommendation to quarantine, treatment, and/or referral to 
community based services and/or contact tracing for those testing positive.  
We will recruit an intent-to-treat sample of 670 adults and estimate 15% attrition for a final sample 
of 582. Participants in this clinical trial will be recruited through a combination of strategies. Fliers 
will be posted throughout Essex County in public spaces, restaurants, and health care clinics, and 
community based organizations. People who call the study will be encourage to disseminate the 
study to their friends and family. The NCCB will reach out to their contacts and networks. 
 
5. 
PARTICIPANTS (approximate number and all applicable categories): 
Number of participants proposed:  670 
 
 Female      
  Male 
 
 
 
  Children (17 or younger) 
 
 Inmates or prisoners 
  Prisoners 
 
 
 
 Cognitive impaired persons 
  Pregnant women 
 
 
 Non-English speaking persons 
 
 
6.  
COST AND PAYMENTS: (Will there be incentives for this project?) 
Participants will receive $30 for completing the baseline interview and $40 for completing each of 
two follow-up interviews.  A randomly selected sample of 35 participants who do not complete 
testing will receive $50 for completing an in-depth, qualitative interview. Thus, an eligible 
participant could receive up to $160 for completing all data collection activities. 
 
7. 
ATTACHMENTS:  All relevant project materials and documents, including 
 
 
Surveys, questionnaires, interview instruments 
 
Informed Consent and Assent (if applicable) forms 
 
Letters of approval on letterhead from cooperating agencies, schools, boards of 
education, etc. 
 
Debriefing statement or explanation sheet if applicable 
 
Participant recruitment materials (e.g., fliers, advertisements) 
         Other: 
 
 
8. 
CONFIDENTIALITY OF DATA: how data will be stored and collected 
Data will be generated and collected through interpersonal computer assisted interviews, 
computer assisted self-interviews, group session audio recordings, in-depth qualitative interviews 
and SARS antigen tests for COVID-19. Each participant will complete an initial telephone 
screening, a computer-assisted baseline and two follow-up interviews (2 weeks and 5 weeks post 

baseline) and at least one COVID test. The electronic files generated through data collection and 
the test results will be identified by code numbers only and kept in password-protected and 
HIPAA-compliant devices and cloud storage, separate from identifying information and available 
only to project staff. This helps to ensure that no identifying information will be disclosed in the 
unlikely event that computerized data are stolen or otherwise seen by unauthorized persons. All 
identifying electronic data will be destroyed immediately after data collection is completed. Signed 
consent forms and audio recordings will be kept for 3 years after study completion. De-identified 
electronic data will be kept indefinitely. Study participants may ask at any time to have recordings 
of their interview destroyed by calling/e-mailing one of the Principal Investigators at the numbers 
provided in the informed consent forms.  
 
9. 
RISKS AND BENEFITS: Describe Risks and Benefits 
The main potential risks of this study include inadvertent violation of confidentiality and emotional 
distress on the part of participants. The procedures described above are intended to prevent 
violations of confidentiality. It is important to be aware that the prospect of testing positive for 
COVID-19 may be a cause of substantial fear and anxiety among participants. We anticipate that 
more than half of our participants will be African American or Hispanic and may lack trust in 
medical science and practice as a legacy of medical mistreatment. Many participants will have 
lost loved ones to COVID-19 and all of them will be medically or socially vulnerable to poor 
outcomes if they become infected themselves. They live with disproportionate risk caused by any 
of several factors, including but not limited to employment as essential workers, poverty, 
inadequate or unstable housing and underlying medical conditions.  
It is also possible that participants who decline testing and attend Critical Dialogue sessions may 
be disturbed by sensitive questions raised during those sessions. Questions and discussions 
regarding stigma, racism, discrimination and structural inequality may cause anxiety, anger, 
suspicion, or other emotions.  While we expect our sample to be predominantly African American, 
there will be some White and Latino participants as well and talking about racism in the group will 
elicit strong emotions. Differences among group members have the potential to harm or cause 
discomfort for a participant or to revive psychological dynamics that could threaten to renew old 
conflicts. We are using a trained facilitator who is from the community and has a great deal of 
experiential knowledge dealing with these sensitive topics and with this marginalized population. 
In the unlikely event a discussion escalates to the point that it may challenge the safety of the 
group, there is an emergency protocol in place where trained clinical staff and security can 
intervene and deflect potential violence or stabilize medical emergencies. 
The potential benefits to participants in this study and other members of the community are 
significant and may be long lasting. Significant short-term benefits include detecting and treating 
cases of COVID-19 and preventing further transmission of the disease. While participants are 
enrolled in the study, referrals to resources to address social determinants of health (e.g., 
housing, food insecurity) may provide immediate tangible benefits. In addition, if participants 
express a need for mental health assistance at any time, the project team and the NCCB are well 
equipped to either provide service or make appropriate referrals. After engaging in the 
interventions, participants may experience increased feelings of empowerment and self-esteem, 
both of which have been associated with improved health outcomes. If the study succeeds in 
reducing medical mistrust and increasing health literacy, those benefits may be long-lasting. Both 
the short-term and long-term potential benefits of this study justify the potential risks involved in 
participation. 
 
10. 
INFORMED CONSENT: Description of consents 
Eligible individuals will provide written informed consent before participating in the study. During 
the informed consent process, the study outreach worker or research assistant will explain the 
study design in detail, including its purpose, the source of funding, why individuals are invited to 
participate, what they will be asked to do, how long the study will last and how many people are 
expected to take part in the study. They will explain the processes of SARS antigen testing and 

randomization, the interventions being tested, potential sources of risk and discomfort and 
measures designed to minimize both. They will answer all participant questions and will ask 
participants to describe in their own words what they expect to do in the study before obtaining 
signatures. Participants who do not comprehend the study description will not be enrolled. 
Participants who would like some time to think before deciding will be able to take informed 
consent material home with them for review and consideration. All participants who provide 
written consent will receive a copy of the consent document which, in addition to the study 
description outlined above, includes names and contact information (phone numbers and email) 
for the Principal Investigators and for the appropriate ethics officials at NJCRI. 
 
11.  
COLLABORATION: Describe any collaborations, Memorandums of Agreements or sub 
 
grantees 
The primary grantee is the University of Illinois at Urbana-Champaign (UIUC), the home 
institution of Principal Investigator (PI) Liliane Windsor.  NJCRI, the home institution of the second 
PI, Ellen Benoit, is a sub grantee. Because all of the human participant research will take place at 
NJCRI, the IRB at UIUC has agreed to sign a deferral letter recognizing the IRB at NJCRI as the 
IRB of review.  UIUC will submit this letter upon receipt of documentation that NJCRI’s IRB has 
approved the study protocol. 
The University of Michigan at Ann Arbor is also a sub grantee, to support the effort of Co-
Investigator Rogério Pinto.  The University has agreed to sign a deferral letter recognizing the 
IRB at NJCRI as the IRB of review and to submit the letter upon receipt of documentation that 
NJCRI’s IRB has approved the study protocol. 
 

Seeking Cures for Tomorrow, Providing Support for Today.
393 Central Avenue * Newark, N.J. * 07103-2842 * (973) 483-3444 * Fax (973) 648-0312
E-Mail: njcri@njcri.org                                                                   Web Site: www.njcri.org
FOUNDER
William P. Orr, M.A.
BOARD OF TRUSTEES
John V. Jacobi
Chair
Thomas Flynn, MBA,FACHE
Treasurer
Jeffrey Bomser
In Memoriam
INSTITUTIONAL REVIEW BOARD
James M. Oleske, M.D.
Chair
YOUTH ADVISORY BOARD
Rachel Jackson
Chair
DIRECTORS
Brian McGovern, L.S.W.
Chief Executive Officer
Joseph Rothenberg., M.B.A.
Chief Financial Officer
Awilda Rivera, B.S.
Director of Operations
Ronald Poblete, M.D.
Medical Director
Corey DeStefano, B.S.
Director of Research
Russell Miller
Director of Development
Henry Iwuala, MPA, LCADC, CCS
Behavioral Health Services, Director
Edward J. Raiten
Director of Care and Treatment
Jason Dotson, MHS, LAC, LCADC
Director of Community, LGBT & Support
Services 
TO: Liliane Cambraia Windsor, PhD University of Illinois at Urbana- Champaign and Ellen 
Benoit, PhD North Jersey Community Research Initiative (NJCRI)
FROM: James Oleske, MD, MPH Chairman of the NJCRI IRB FWA# 00001870
APPROVAL DATE:
December 23.2020
Re:   IRB Review and Approval of the Project: Optimization of a new adaptive intervention
To increase COVID-19 testing among people at high risk in an urban community, 
Protocol #: CWCOVIDSUPP-UIUC-NJCRI 102497-18274-267805 version 1.0
  
The NJCRI IRB has reviewed and approved the project for Initial Submission: Community Wise
COVID Supplement: Optimization of a new adaptive intervention to increase COVID-19
testing among people at high risk in an urban community on December 23, 2020. All
documents that were approved: Informed consent, surveys/ instruments, questionnaires, 
interview and recruitment materials.  
Please keep the IRB updated on the outcomes of this project and send all correspondence or 
updated study documents to the NJCRI IRB for review. Any proposed changes to the project 
must be submitted to the IRB as an amendment for review and approval prior to implementation. 
The next continuing review and update will be on December 23, 2021. If there are any anticipated 
problems involving risk to subjects or others must be reported to the IRB. The IRB has reviewed 
and approved the consent and/or assent process, waiver and/or alteration described in this
protocol as required by 45 CFR 46 and 21 CFR 50, 56, (if FDA regulated research). Only the 
versions of the documents included in the approved process may be used to document informed 
consent and/or assent of study subjects; each subject must receive a copy of the approved 
form(s); and a copy of each signed form must be filed in a secure place in the subject's 
medical/patient/research record. Please notify the IRB when the study has been completed or 
stopped for any reason. 
________________________________________________              12/23/2020
James Oleske, MD, MPH Chairman of the NJCRI IRB                           Date