Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05305443 |
| Other study ID # |
UIUC-IRB 22606 |
| Secondary ID |
1U01AI169469-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 4, 2022 |
| Est. completion date |
August 28, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
University of Illinois at Urbana-Champaign |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
Description:
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:
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.
