Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
554 participants
INTERVENTIONAL
2022-04-04
2023-08-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optimization of a New Adaptive Intervention to Increase COVID-19 Testing
NCT04757298
Addressing Psychosocial Comorbidities in HIV Treatment and Prevention 2b
NCT05352061
Infectious Disease (ID) Testing OUtreach in Carceral Hubs
NCT06679751
Centering Those Engaged in Transactional Sex: A PrEP Innovation for Getting To Zero
NCT05929521
Seek, Test, Treat, Retain: An Integrated Jail-Prison-Community Model for Illinois
NCT01852877
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Navigation/tested/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 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/tested/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 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
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/not tested/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.
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/not tested/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)
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
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.
Referral/tested/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.
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 IL recommendations is e-mailed or texted to participants.
Referral/tested/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).
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.
Referral/not tested/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.
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 IL recommendations is e-mailed or texted to participants.
Referral/not tested/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).
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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.
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.
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 IL recommendations is e-mailed or texted to participants.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* having high risk to contract COVID or develop related complications
* able to speak English
* able and willing to provide informed consent.
Exclusion Criteria
* not at high risk to contract COVID or develop related complications
* unable to speak English
* unable and unwilling to provide informed consent
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Comprehensive Behavioral Health Center
UNKNOWN
North Jersey Community Research Initiative
OTHER
University of Michigan
OTHER
University of Illinois at Urbana-Champaign
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Liliane Cambraia Windsor
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Comprehensive Behavioral Health Center
East Saint Louis, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UIUC-IRB 22606
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.