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| ID | Type | Description | Link |
|---|---|---|---|
| 3R01MD010629-04S2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| North Jersey Community Research Initiative | OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| University of Michigan | 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 North Jersey Community Research Initiative (NJCRI)
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 NJ 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 NJ 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 670 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 Essex County, NJ based on their previous experience and because the parent study research team has established relationships with other service agencies in the community from which, in addition to NJCRI, 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 NJ recommendations adherence, using standard sample size formula for difference of two proportions, a total sample size of 582 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 NJ recommendations. The 582 sample size has 85% to detect a difference of 15% in adherence rates to NJ recommendations between two interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigation only | Other | Participants are randomized to receive navigation services only. |
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| Navigation + Brief Counseling | Other | After initial randomization into NS, some participants are randomized to receive Brief Counseling (BC) |
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| Navigation + Critical Dialogue | Other | After initial randomization into NS, some participants are randomized to receive Critical Dialogue (CD) |
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| Brochure only | Other | Participants are randomized to receive Brochure only. |
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| Brochure + Brief Counseling | Other | After initial randomization to receive a brochure, some participants are randomized to receive Brief Counseling (BC) |
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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 |
|---|---|---|
| Stage 1: Completion of COVID-19 Test After First Randomization | For the first stage intervention, the primary outcome is coming to the agency and completing the COVID-19 antigen test one week after completing the baseline. | Stage 1: Within one week of completing baseline. |
| 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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| Name | Affiliation | Role |
|---|---|---|
| Liliane Windsor, PhD | University of Illinois Urbana Champaign | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Jersey Community Research Initiative | Newark | New Jersey | 07102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37415099 | Derived | Lee CA, Gamino D, Lore M, Donelson C, Windsor LC. Use of research electronic data capture (REDCap) in a sequential multiple assignment randomized trial (SMART): a practical example of automating double randomization. BMC Med Res Methodol. 2023 Jul 6;23(1):162. doi: 10.1186/s12874-023-01986-6. | |
| 36865151 | Derived | Lee CA, Gamino D, Lore M, Donelson C, Windsor LC. Use of research electronic data capture (REDCap) in a sequential multiple assignment randomized trial (SMART): A practical example of automating double randomization. Res Sq [Preprint]. 2023 Feb 24:rs.3.rs-2573133. doi: 10.21203/rs.3.rs-2573133/v1. |
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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 North Jersey Community Research Initiative (NJCRI), one of New Jersey's largest and most comprehensive HIV/AIDS community-based organization.
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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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| Second Intervention |
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This represents the Stage 2 baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Navigation (1)+ Navigation (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 | Stage 1: Completion of COVID-19 Test After First Randomization | For the first stage intervention, the primary outcome is coming to the agency and completing the COVID-19 antigen test one week after completing the baseline. | Population for Stage 1 | Posted | Number | participants | Stage 1: Within one week of completing baseline. |
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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 | At Stage 1 randomization, participants were assigned to receive navigation services(NS). 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 |
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Note that 46% of the sample never completed follow-up 4.
| 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 | Yes | No | No | Study Protocol | Dec 20, 2020 | Nov 21, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2022 | Nov 21, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 26, 2021 | Nov 27, 2023 | ICF_002.pdf |
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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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SMART Design
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| Brochure + Critical Dialogue |
| Other |
After initial randomization to receive a brochure, some participants are randomized to receive Critical Dialogue (CD) |
|
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| 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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| 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. |
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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 NJ recommendations is e-mailed or texted to participants. |
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| 35421999 | Derived | Windsor L, Benoit E, M Pinto R, Sarol J. Optimization of a new adaptive intervention using the SMART Design to increase COVID-19 testing among people at high risk in an urban community. Trials. 2022 Apr 14;23(1):310. doi: 10.1186/s13063-022-06216-w. |
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| NOT COMPLETED |
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| BG001 | Navigation (1) + Brief Counseling (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 (1) + Critical Dialogue (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 (1) + Brochure (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 (1)+ Brief Counseling (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 (1) + Critical Dialogue (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 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Self-report biological sex assigned at birth | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Participants were asked to select all races that applied to them. Thus, summation of responses will not equate to the total analyzed sample. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| COVID tested within previous 30 days | Participants reported they had taken a COVID test within the prior 30 days | Count of Participants | Participants |
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| 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 e-mailed 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. | Population includes baseline at Stage 2. | Posted | Number | participants | Stage 2: 6 months post baseline (4th follow up visit) |
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| 0 |
| 328 |
| 0 |
| 328 |
| 0 |
| 328 |
| EG001 | Stage 2: Navigation Followed by Navigation | After Stage 1 randomization to receive Navigation Services (NS) participants will again be randomized and continue receiving NS. 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 | 160 | 0 | 160 | 0 | 160 |
| EG002 | Stage 2: Navigation Followed by Brief Counseling | After Stage 1 randomization to receive Navigation Services (NS), participants will again be randomized to receive Brief Counseling (BC) 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 | 36 | 0 | 36 | 0 | 36 |
| EG003 | Stage 2: Navigation Followed by Critical Dialogue | After Stage1 randomization to receive Navigation Services (NS), participants will again be randomized and assigned to Critical Dialogue (CD) 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 | At Stage 1 randomization, participants will be assigned to receive standard brochure services. 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 | 340 | 0 | 340 | 0 | 340 |
| EG005 | Stage 2: Brochure Followed by Brochure | After Stage 1 randomization to Brochure, participants will again be randomized and some will be assigned to again receive 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 e-mailed or texted to participants. | 0 | 165 | 0 | 165 | 0 | 165 |
| EG006 | Stage 2: Brochure Followed by Brief Counseling | After Stage 1 randomization to Brochure, participants will again be randomized and some will be assigned to receive Brief Counseling (BC). 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 | 32 | 0 | 32 | 0 | 32 |
| EG007 | Stage 2: Brochure Followed by Critical Dialogue | After Stage 1 randomization to Brochure, participants will again be randomized and some will be assigned to Critical Dialogue (CD). 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 | 137 | 0 | 137 | 0 | 137 |
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| Missing |
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