Optimization of a New Adaptive Intervention to Increase COVID-19 Testing

NCT04757298 | Completed Results DMC

• 2 other identifiers: UIUC-NJCRI 102497-18274-2678053R01MD010629-04S2
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 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 North Jersey Community Research Initiative (NJCRI)

Conditions

COVID-19 Testing

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (6)

Navigation only

OTHER

Participants are randomized to receive navigation services only.

Behavioral: Navigation Services

Navigation + Brief Counseling

OTHER

After initial randomization into NS, some participants are randomized to receive Brief Counseling (BC)

Behavioral: Navigation Services; Behavioral: Brief Counseling

Navigation + Critical Dialogue

OTHER

After initial randomization into NS, some participants are randomized to receive Critical Dialogue (CD)

Behavioral: Navigation Services; Behavioral: Critical Dialogue

Brochure only

OTHER

Participants are randomized to receive Brochure only.

Behavioral: Referral and Digital Brochure

Brochure + Brief Counseling

OTHER

After initial randomization to receive a brochure, some participants are randomized to receive Brief Counseling (BC)

Behavioral: Brief Counseling; Behavioral: Referral and Digital Brochure

Brochure + Critical Dialogue

OTHER

After initial randomization to receive a brochure, some participants are randomized to receive Critical Dialogue (CD)

Behavioral: Critical Dialogue; Behavioral: Referral and Digital Brochure

Interventions

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

Navigation + Brief Counseling; Navigation + Critical Dialogue; Navigation only

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.

Brochure + Critical Dialogue; Navigation + Critical Dialogue

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.

Brochure + Brief Counseling; Navigation + Brief Counseling

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.

Brochure + Brief Counseling; Brochure + Critical Dialogue; Brochure only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• North Jersey Community Research Initiative: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of Michigan: collaborator

Study Sites (1)

North Jersey Community Research Initiative

Newark, New Jersey, 07102, United States

Location

Related Publications (3)

• 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.

  PMID: 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. Res Sq [Preprint]. 2023 Feb 24:rs.3.rs-2573133. doi: 10.21203/rs.3.rs-2573133/v1.

  PMID: 36865151 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.

  PMID: 35421999 DERIVED

MeSH Terms

Interventions

Referral and Consultation

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Limitations and Caveats

Note that 46% of the sample never completed follow-up 4.

Results Point of Contact

• Title: Dr. Liliane Windsor
• Organization: University of Illinois Urbana Champaign

lwindsor@illinois.edu

217-300-1782

Study Officials

• Liliane Windsor, PhD

  University of Illinois Urbana Champaign

  PRINCIPAL INVESTIGATOR

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: Professor

Model Details: SMART Design

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 17, 2021
• Study Start: February 12, 2021
• Primary Completion: October 25, 2022
• Study Completion: October 25, 2022
• Last Updated: February 15, 2024
• Results First Posted: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, ANALYTIC CODE
• Time Frame: Upon request after the study is complete
• Access Criteria: Must sign a data sharing agreement

Locations

US (1)