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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI169469-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Comprehensive Behavioral Health Center | UNKNOWN |
| North Jersey Community Research Initiative | OTHER |
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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigation/tested/navigation services | Experimental | 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. |
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| Navigation/tested/brief counseling | Experimental | 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) |
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| Navigation/not tested/navigation services | Experimental | 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. |
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| Navigation/not tested/critical dialogue | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigation Services | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Behavioral Health Center | East Saint Louis | Illinois | 62201 | United States |
De-identified data can be shared upon request for research purposes and under a data sharing agreement.
Upon request after the study is complete
Must sign a data sharing agreement
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Participants were recruited into the study at the Comprehensive Behavioral Health Center (CBHC), one of southern Illinois' largest and most comprehensive behavioral health providers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stage 1: Navigation | Participants in this arm were randomized to receive Navigation Services for Stage 1 |
| FG001 | 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 |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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 |
| FG007 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1: First Intervention |
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| Stage 2: Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Navigation (Stage 1) + Navigation (Stage 2) | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Within one week of the intervention session |
|
Adverse event data were collected from baseline through follow up sessions (6 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stage 1: Navigation | Participants in this arm were randomized to receive Navigation Services for Stage 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Liliane Windsor | University of Illinois Urbana Champaign | 217-300-1782 | lwindsor@illinois.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Feb 28, 2023 | Aug 2, 2024 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 30, 2022 | Aug 1, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| University of Michigan |
| OTHER |
SMART Design
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| Referral/tested/brochure |
| Experimental |
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. |
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| Referral/tested/brief counseling | Experimental | 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). |
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| Referral/not tested/brochure | Experimental | 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. |
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| Referral/not tested/critical dialogue | Experimental | 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). |
|
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| Brief Counseling | Behavioral | 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. |
|
| Critical Dialogue | Behavioral | 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. |
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| Referral and Digital Brochure | Behavioral | 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. |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Navigation (Stage 1) + Brief Counseling (Stage 2) | 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. |
| BG002 | 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 |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Not Randomized After Stage 1 | Participants in this group were not randomized following Stage 1 |
| BG007 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Number | participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| COVID tested within previous 30 days | Count of Participants | Participants |
|
| OG001 | Brochure Only | 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. |
|
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| Primary | 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. | Posted | Count of Participants | Participants | Stage 2: 6 months post baseline (4th follow up visit) |
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|
|
| 0 |
| 278 |
| 0 |
| 278 |
| 0 |
| 278 |
| EG001 | 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 | 0 | 138 | 0 | 138 | 0 | 138 |
| EG002 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | 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. | 0 | 126 | 0 | 126 | 0 | 126 |
| EG004 | 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. | 0 | 273 | 0 | 273 | 0 | 273 |
| EG005 | 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. | 0 | 128 | 0 | 128 | 0 | 128 |
| EG006 | 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 | 0 | 6 | 0 | 6 | 0 | 6 |
| EG007 | 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. | 0 | 122 | 0 | 122 | 0 | 122 |
| EG008 | Not Randomized After Stage 1 | Participants in this group were not randomized after Stage 1. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |