COVID-19 Treatment Cascade Optimization Study

Not Applicable

Completed

Conditions: COVID-19

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

Registration Number: NCT05305443

Lead Sponsor: University of Illinois at Urbana-Champaign

Brief Summary: 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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 554

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 & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Navigation/tested/brief counseling	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 be assigned to receive Brief Counseling (BC)
Referral/tested/brochure	Referral and Digital 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.
Navigation/tested/navigation services	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.
Navigation/tested/brief counseling	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)
Navigation/not tested/navigation services	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.
Referral/tested/brief counseling	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).
Referral/not tested/brochure	Referral and Digital 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.
Navigation/not tested/critical dialogue	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 be assigned to Critical Dialogue (CD)
Navigation/not tested/critical dialogue	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)
Referral/not tested/critical dialogue	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).

Primary Outcome Measures

Name	Time	Method
Completion of COVID-19 Test	Within one week of the intervention session	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.
Stage 2: Reported COVID Test in Last 30 Days at 6 Months Post Baseline	Stage 2: 6 months post baseline (4th follow up visit)	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.

Secondary Outcome Measures