COVID-19 Treatment Cascade Optimization Study

University of Illinois at Urbana-Champaign

Status: Completed

Conditions: COVID-19

Treatments: Behavioral: Brief Counseling; Behavioral: Critical Dialogue; Behavioral: Referral and Digital Brochure; Behavioral: Navigation Services

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05305443

UIUC-IRB 22606

1U01AI169469-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 554 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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554 participants in 8 patient groups

Navigation/tested/navigation services

Experimental group

Description:

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.

Treatment:

Behavioral: Navigation Services

Navigation/tested/brief counseling

Experimental group

Description:

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)

Treatment:

Behavioral: Navigation Services

Behavioral: Brief Counseling

Navigation/not tested/navigation services

Experimental group

Description:

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.

Treatment:

Behavioral: Navigation Services

Navigation/not tested/critical dialogue

Experimental group

Description:

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)

Treatment:

Behavioral: Navigation Services

Behavioral: Critical Dialogue

Referral/tested/brochure

Experimental group

Description:

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.

Treatment:

Behavioral: Referral and Digital Brochure

Referral/tested/brief counseling

Experimental group

Description:

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).

Treatment:

Behavioral: Brief Counseling

Referral/not tested/brochure

Experimental group

Description:

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.

Treatment:

Behavioral: Referral and Digital Brochure

Referral/not tested/critical dialogue

Experimental group

Description:

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).

Treatment:

Behavioral: Critical Dialogue