COVID-19 Treatment Cascade Optimization Study
2 other identifiers
interventional
554
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Apr 2022
Typical duration for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedStudy Start
First participant enrolled
April 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2023
CompletedResults Posted
Study results publicly available
November 26, 2024
CompletedNovember 26, 2024
October 1, 2024
1.4 years
March 30, 2022
September 3, 2024
October 31, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (8)
Navigation/tested/navigation services
EXPERIMENTALAfter 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
EXPERIMENTALAfter 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
EXPERIMENTALAfter 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/not tested/critical dialogue
EXPERIMENTALAfter 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/tested/brochure
EXPERIMENTALAfter 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/tested/brief counseling
EXPERIMENTALAfter 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
EXPERIMENTALAfter 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/not tested/critical dialogue
EXPERIMENTALAfter 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).
Interventions
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 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 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 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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Illinois at Urbana-Champaignlead
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Comprehensive Behavioral Health Centercollaborator
- North Jersey Community Research Initiativecollaborator
- University of Michigancollaborator
Study Sites (1)
Comprehensive Behavioral Health Center
East Saint Louis, Illinois, 62201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Liliane Windsor
- Organization
- University of Illinois Urbana Champaign
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 30, 2022
First Posted
March 31, 2022
Study Start
April 4, 2022
Primary Completion
August 28, 2023
Study Completion
August 28, 2023
Last Updated
November 26, 2024
Results First Posted
November 26, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Upon request after the study is complete
- Access Criteria
- Must sign a data sharing agreement
De-identified data can be shared upon request for research purposes and under a data sharing agreement.