COVID-19 Treatment Cascade Optimization Study

This study tests an adaptation of the HIV Continuum of Prevention, Care, and Treatment Framework (CoPCT) for use in tracking COVID-19 testing and follow-up in a medically and socially vulnerable population. This study uses an integrated research collaborative framework that facilitates dialogue among researchers, community members, and service providers as a tool for optimizing the adaptive intervention and will take place at the Comprehensive Behavioral Health Center (CCHC).

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Behavioral: Navigation Services; Behavioral: Brief Counseling; Behavioral: Critical Dialogue; Behavioral: Referral and Digital Brochure

Detailed Description

This study will use the Multiphase Optimization Strategy (MOST) to optimize an adaptive intervention that successfully navigates COVID-19 medically or socially vulnerable people through a continuum of prevention, care and treatment (CoPCT) modeled on the HIV CoPCT. The COVID-19 CoPCT starts with testing and continues with successful adherence to prevention or treatment guidelines to help prevent and/or treat COVID-19. The study will assess the effectiveness of Navigation Services compared to referrals in increasing COVID-19 testing and Brief Counseling in increasing adherence to the State of IL recommendations for COVID-19 prevention and treatment. The study will also examine the effect of Critical Dialogue on testing behavior among people who decline to be tested for COVID-19. The investigators will develop decision rules about what evidence-based-interventions work best for what types of people (e.g., those who test right away, versus decliners) and in what period of the COVID-19 continuum. Finally, the study will shed light on factors associated with testing and adherence to IL recommendations. Investigators will follow Community Based Participatory Research principles in implementing a sequential, multiple assignment randomized trial (SMART) design. Adjusting for possible 15% loss to follow-up, a total sample of 548 people who are medically and socially vulnerable to infection and poor outcomes with COVID-19 will be enrolled as the intent-to treat-sample. The investigators are confident that they can recruit this sample in St. Clair County, IL based on their previous experience and because the research team has established relationships with other service agencies in the community from which, in addition to CBHC, research participants will be drawn. The primary outcome is completion of the COVID-19 test within one week of the first intervention session. The study will include 3 stages in which participants will be randomized to one of two possible interventions as follows:

1. Eligible and consenting participants will be randomized to receive the first-stage intervention: Navigation Services (NS) or standard services (referral to testing and IL digital information brochure after testing). The primary outcome is completion of the COVID-19 test within one week of the intervention session.
2. Those who get tested will be randomized to receive the second-stage intervention: continue with NS or standard treatment or switch to Brief Counseling (BC). The outcome will be adherence to IL recommendations. For those testing positive, adherence means engaging in a 14-day quarantine, receiving medical care as needed and contact tracing. For those testing negative, adherence means social distancing and wearing masks.
3. Those who do not get tested will be randomized into their second-stage intervention to continue with NS or digital brochure or switch to Critical Dialogue (CD). The outcome will be completing COVID-19 testing within 1 week of the second stage intervention session. Those who complete the testing will then be randomized to either continue with NS or digital brochure or switch to BC. Those who do not get tested will be randomized to continued NS or digital brochure or switch to CD. The outcome will be adherence to NJ recommendations, as defined above. All variables will be measured using standardized measures selected from the National Institutes of Health (NIH) PhenX Toolkit.

For the primary aim of comparing effects of Navigation Services versus referral on testing behavior and IL recommendations adherence, using standard sample size formula for difference of two proportions, a total sample size of 466 subjects is needed to have 80% power at α=0.05 to detect a 10% difference in proportions, assuming 70% in the referral group will complete testing and adhere to specific IL recommendations. The 466 sample size has 85% to detect a difference of 15% in adherence rates to IL recommendations between two interventions.

• Study Type: Interventional
• Enrollment (Actual): 554
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • East Saint Louis, Illinois, United States, 62201
      • Comprehensive Behavioral Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• over 18 years of age
• having high risk to contract COVID or develop related complications
• able to speak English
• able and willing to provide informed consent.

Exclusion Criteria:

• under 18 years of age
• not at high risk to contract COVID or develop related complications
• unable to speak English
• unable and unwilling to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Navigation/tested/navigation services; After initial randomization, some participants will be assigned to receive navigation services(NS). Those who complete the COVID-19 testing will again be randomized and some will continue receiving NS.	Behavioral: Navigation Services; Navigation services include assessment and support with service referrals. Each participant will meet with a peer navigator in person or on Zoom Conferencing for 30 minutes to go over results from their social and health needs assessment that is retrieved from the baseline assessment. The navigator shares information about COVID-19, answers questions about testing, and makes referrals to other needed services
Experimental: Navigation/tested/brief counseling; After initial randomization, some participants will be assigned to receive navigation services (NS). Those who complete the COVID-19 testing will again be randomized and some will be assigned to receive Brief Counseling (BC)	Behavioral: Navigation Services; Navigation services include assessment and support with service referrals. Each participant will meet with a peer navigator in person or on Zoom Conferencing for 30 minutes to go over results from their social and health needs assessment that is retrieved from the baseline assessment. The navigator shares information about COVID-19, answers questions about testing, and makes referrals to other needed services; Behavioral: Brief Counseling; Brief Counseling is a 15-minute post-COVID-19 test session delivered by a trained licensed clinician in person or via Zoom Conferencing. In the session, the clinician shares the test results and offers recommendations and information about COVID-19 treatment and prevention.
Experimental: Navigation/not tested/navigation services; After initial randomization, some participants will be assigned to receive navigation services (NS). Those who do not complete the COVID-19 testing will again be randomized and some will continue receiving NS.	Behavioral: Navigation Services; Navigation services include assessment and support with service referrals. Each participant will meet with a peer navigator in person or on Zoom Conferencing for 30 minutes to go over results from their social and health needs assessment that is retrieved from the baseline assessment. The navigator shares information about COVID-19, answers questions about testing, and makes referrals to other needed services
Experimental: Navigation/not tested/critical dialogue; After initial randomization, some participants will be assigned to receive navigation services(NS). Those who do not complete the COVID-19 testing will again be randomized and some will be assigned to Critical Dialogue (CD)	Behavioral: Navigation Services; Navigation services include assessment and support with service referrals. Each participant will meet with a peer navigator in person or on Zoom Conferencing for 30 minutes to go over results from their social and health needs assessment that is retrieved from the baseline assessment. The navigator shares information about COVID-19, answers questions about testing, and makes referrals to other needed services; Behavioral: Critical Dialogue; Critical Dialogue includes three one-hour-long, open-group-sessions facilitated in person or online by a trained licensed facilitator. Group critical dialogue is prompted by thematic images developed by the NCCB to foster a deeper understanding of how systematic stigma, feelings of rage as victims of discrimination, and/or apathy may impact participants' beliefs and behaviors related to COVID-19 and empower participants to make critical choices to protect their health and the health of their communities.
Experimental: Referral/tested/brochure; After initial randomization, some participants will be assigned to receive standard referral services. Those who complete the COVID-19 testing will again be randomized and some will receive a digital brochure.	Behavioral: Referral and Digital Brochure; Referral will consist of a five-minute phone call where an outreach worker offers participants information about COVID-19 testing and encourages them to get tested within one week. A digital brochure containing IL recommendations is e-mailed or texted to participants.
Experimental: Referral/tested/brief counseling; After initial randomization, some participants will be assigned to receive standard referral services. Those who complete the COVID-19 testing will again be randomized and some will be assigned to receive Brief Counseling (BC).	Behavioral: Brief Counseling; Brief Counseling is a 15-minute post-COVID-19 test session delivered by a trained licensed clinician in person or via Zoom Conferencing. In the session, the clinician shares the test results and offers recommendations and information about COVID-19 treatment and prevention.
Experimental: Referral/not tested/brochure; After initial randomization, some participants will be assigned to receive standard referral services. Those who do not complete the COVID-19 testing will again be randomized and some will receive a digital brochure.	Behavioral: Referral and Digital Brochure; Referral will consist of a five-minute phone call where an outreach worker offers participants information about COVID-19 testing and encourages them to get tested within one week. A digital brochure containing IL recommendations is e-mailed or texted to participants.
Experimental: Referral/not tested/critical dialogue; After initial randomization, some participants will be assigned to receive standard referral services. Those who do not complete the COVID-19 testing will again be randomized and some will be assigned to Critical Dialogue (CD).	Behavioral: Critical Dialogue; Critical Dialogue includes three one-hour-long, open-group-sessions facilitated in person or online by a trained licensed facilitator. Group critical dialogue is prompted by thematic images developed by the NCCB to foster a deeper understanding of how systematic stigma, feelings of rage as victims of discrimination, and/or apathy may impact participants' beliefs and behaviors related to COVID-19 and empower participants to make critical choices to protect their health and the health of their communities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage 2: Reported COVID Test in Last 30 Days at 6 Months Post Baseline	For the second stage intervention, the primary outcome is self-reported completion of COVID-19 test in the past 30 days at the follow up completed 6 months after baseline. Study participants were asked whether they had completed a COVID-19 test in the past 30 days.	Stage 2: 6 months post baseline (4th follow up visit)
Completion of COVID-19 Test	Eligible and consenting participants will be randomized to receive the first-stage intervention: Navigation Services (NS) or standard services (referral to testing and IL digital information brochure after testing). The primary outcome is completion of the COVID-19 test within one week of the intervention session.	Within one week of the intervention session

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); University of Michigan; North Jersey Community Research Initiative; Comprehensive Behavioral Health Center

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Actual): August 28, 2023
• Study Completion (Actual): August 28, 2023

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: UIUC-IRB 22606; 1U01AI169469-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data can be shared upon request for research purposes and under a data sharing agreement.
• IPD Sharing Time Frame: Upon request after the study is complete
• IPD Sharing Access Criteria: Must sign a data sharing agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No