Trial Outcomes & Findings for COVID-19 Treatment Cascade Optimization Study (NCT NCT05305443)

Last Updated: 2024-11-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

554 participants

Primary outcome timeframe

Within one week of the intervention session

Results posted on

2024-11-26

Participant Flow

Participants were recruited into the study at the Comprehensive Behavioral Health Center (CBHC), one of southern Illinois' largest and most comprehensive behavioral health providers.

Participant milestones

Participant milestones
Measure	Stage 1: Navigation Participants in this arm were randomized to receive Navigation Services for Stage 1	Stage 2 Navigation Followed by Navigation Participants in this arm were first randomized to receive Navigation Services in Stage 1 and then were randomized again to receive Navigation Services in Stage 2 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	Stage 2: Navigation Followed by Brief Counseling Participants in this arm were randomized into Navigation Services in Stage 1 then randomized into Brief Counseling in Stage 2. 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.	Stage 2: Navigation Followed by Critical Dialogue Participants in this arm were first randomized to receive Navigation Services in Stage 1 then randomized to receive Critical Dialogue in Stage 2. 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.	Stage 1: Brochure Participants in this group were randomized to receive a digital brochure in Stage 1. 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 NJ recommendations is e-mailed or texted to participants.	Stage 2: Brochure Followed by Brochure Participants in this group were randomized to receive a brochure in Stage 1 and randomized to receive a brochure in Stage 2. 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 NJ recommendations is e-mailed or texted to participants.	Stage 2: Brochure Followed by Brief Counseling Participants in this group were randomized to receive a brochure in Stage 1 and randomized to receive Brief Counseling in Stage 2. 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	Stage 2: Brochure Followed by Critical Dialogue Participants in this group were randomized to receive a Brochure in Stage 1 and randomized to receive Critical Dialogue in Stage 2. 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.
Stage 1: First Intervention STARTED	278	0	0	0	276	0	0	0
Stage 1: First Intervention COMPLETED	132	0	0	0	276	0	0	0
Stage 1: First Intervention NOT COMPLETED	146	0	0	0	0	0	0	0
Stage 2: Second Intervention STARTED	0	141	10	126	0	140	6	126
Stage 2: Second Intervention COMPLETED	0	24	10	15	0	5	6	23
Stage 2: Second Intervention NOT COMPLETED	0	117	0	111	0	135	0	103

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

COVID-19 Treatment Cascade Optimization Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Navigation (Stage 1) + Navigation (Stage 2) n=141 Participants Participants in this group were randomized in Stage 1 to receive Navigation Services and randomized to receive Navigation Services in Stage 2. 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	Navigation (Stage 1) + Brief Counseling (Stage 2) n=10 Participants Participants in this Group were randomized to receive Navigation services in Stage 1 and randomized to receive Brief Counseling in Stage 2. 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.	Navigation (Stage 1) + Critical Dialogue (Stage 2) n=126 Participants Participants in this group were randomized to receive Navigation Services in Stage 1 and randomized to receive Critical Dialogue in Stage 2. 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	Brochure (Stage 1) + Brochure (Stage 2) n=140 Participants Participants in this group were randomized in stage 1 to receive a digital brochure and randomized to receive a digital brochure in Stage 2. 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 NJ recommendations is e-mailed or texted to participants.	Brochure (Stage 1)+ Brief Counseling (Stage 2) n=6 Participants Participants in this group were randomized in Stage 1 to receive a Brochure and were randomized to receive Brief Counseling in Stage 2. 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.	Brochure (Stage 1) + Critical Dialogue (Stage 2) n=126 Participants Participants in this group were randomized to receive Navigation Services in Stage 1 and were randomized to receive Critical Dialogue in Stage 2. 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.	Not Randomized After Stage 1 n=5 Participants Participants in this group were not randomized following Stage 1	Total n=554 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	134 Participants n=5 Participants	10 Participants n=7 Participants	119 Participants n=5 Participants	133 Participants n=4 Participants	5 Participants n=21 Participants	118 Participants n=8 Participants	5 Participants n=8 Participants	524 Participants n=24 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	1 Participants n=21 Participants	7 Participants n=8 Participants	0 Participants n=8 Participants	27 Participants n=24 Participants
Sex/Gender, Customized Female	74 participants n=5 Participants	6 participants n=7 Participants	66 participants n=5 Participants	63 participants n=4 Participants	4 participants n=21 Participants	73 participants n=8 Participants	2 participants n=8 Participants	288 participants n=24 Participants
Sex/Gender, Customized Male	60 participants n=5 Participants	4 participants n=7 Participants	54 participants n=5 Participants	73 participants n=4 Participants	1 participants n=21 Participants	48 participants n=8 Participants	3 participants n=8 Participants	243 participants n=24 Participants
Sex/Gender, Customized Unknown/Unreported	7 participants n=5 Participants	0 participants n=7 Participants	6 participants n=5 Participants	4 participants n=4 Participants	1 participants n=21 Participants	5 participants n=8 Participants	0 participants n=8 Participants	23 participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	20 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	121 Participants n=5 Participants	8 Participants n=7 Participants	106 Participants n=5 Participants	123 Participants n=4 Participants	5 Participants n=21 Participants	108 Participants n=8 Participants	4 Participants n=8 Participants	475 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	2 Participants n=7 Participants	14 Participants n=5 Participants	15 Participants n=4 Participants	0 Participants n=21 Participants	15 Participants n=8 Participants	0 Participants n=8 Participants	59 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants	0 Participants n=8 Participants	15 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Black or African American	112 Participants n=5 Participants	9 Participants n=7 Participants	93 Participants n=5 Participants	106 Participants n=4 Participants	3 Participants n=21 Participants	92 Participants n=8 Participants	4 Participants n=8 Participants	419 Participants n=24 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	1 Participants n=7 Participants	18 Participants n=5 Participants	20 Participants n=4 Participants	2 Participants n=21 Participants	21 Participants n=8 Participants	0 Participants n=8 Participants	76 Participants n=24 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=8 Participants	16 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	1 Participants n=8 Participants	26 Participants n=24 Participants
Region of Enrollment United States	141 Participants n=5 Participants	10 Participants n=7 Participants	126 Participants n=5 Participants	140 Participants n=4 Participants	6 Participants n=21 Participants	126 Participants n=8 Participants	5 Participants n=8 Participants	554 Participants n=24 Participants
COVID tested within previous 30 days	39 Participants n=5 Participants	4 Participants n=7 Participants	22 Participants n=5 Participants	27 Participants n=4 Participants	3 Participants n=21 Participants	26 Participants n=8 Participants	1 Participants n=8 Participants	122 Participants n=24 Participants

PRIMARY outcome

Timeframe: Within one week of the intervention session

Outcome measures

Outcome measures
Measure	Navigation (Stage 1) n=278 Participants Participants in this group are randomized to receive Navigation Services in Stage 1. 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	Brochure Only n=276 Participants 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. 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 NJ recommendations is emailed or texted to participants.	Navigation (Stage 1) + Critical Dialogue (Stage 2) Participants in this group were randomized to receive Navigation Services in Stage 1 and randomized to receive Critical Dialogue in Stage 2. 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	Brochure (Stage 1) + Brochure (Stage 2) Participants in this group were randomized in stage 1 to receive a digital brochure and randomized to receive a digital brochure in Stage 2. 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 NJ recommendations is e-mailed or texted to participants.	Brochure (Stage 1)+ Brief Counseling (Stage 2) Participants in this group were randomized in Stage 1 to receive a Brochure and were randomized to receive Brief Counseling in Stage 2. 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.	Brochure (Stage 1) + Critical Dialogue (Stage 2) Participants in this group were randomized to receive Navigation Services in Stage 1 and were randomized to receive Critical Dialogue in Stage 2. 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.
Completion of COVID-19 Test	72 Participants	60 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Navigation (Stage 1) n=141 Participants Participants in this group are randomized to receive Navigation Services in Stage 1. 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	Brochure Only n=10 Participants 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. 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 NJ recommendations is emailed or texted to participants.	Navigation (Stage 1) + Critical Dialogue (Stage 2) n=126 Participants Participants in this group were randomized to receive Navigation Services in Stage 1 and randomized to receive Critical Dialogue in Stage 2. 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	Brochure (Stage 1) + Brochure (Stage 2) n=140 Participants Participants in this group were randomized in stage 1 to receive a digital brochure and randomized to receive a digital brochure in Stage 2. 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 NJ recommendations is e-mailed or texted to participants.	Brochure (Stage 1)+ Brief Counseling (Stage 2) n=6 Participants Participants in this group were randomized in Stage 1 to receive a Brochure and were randomized to receive Brief Counseling in Stage 2. 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.	Brochure (Stage 1) + Critical Dialogue (Stage 2) n=126 Participants Participants in this group were randomized to receive Navigation Services in Stage 1 and were randomized to receive Critical Dialogue in Stage 2. 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.
Stage 2: Reported COVID Test in Last 30 Days at 6 Months Post Baseline	39 Participants	4 Participants	23 Participants	27 Participants	3 Participants	26 Participants

Additional Information

Dr. Liliane Windsor

University of Illinois Urbana Champaign

Phone: 217-300-1782

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place