Clinical trial NCT06682468: Achieving Equity in Patient Outcome Reporting for Timely Assessments of Life With HIV and Substance Use
Official title: Achieving Equity in Patient Outcome Reporting for Timely Assessments of Life With HIV and Substance Use
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Substance Use Disorders
Hiv
Keywords: People Living with HIV
Screening
Substance Use Disorder Screening
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-11-12
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be enrolled into two group intervention and standard care. Patients randomized to the intervention arm will not be blinded to the intervention and will receive the NIDA quick screen via MyChart and at clinic appointments. Patients randomized to the usual care group will receive the NIDA quick screen during appointments with their clinicians and, thus, be blinded to trial assignments. HIV clinicians have been informed of the intervention and will not be informed of the randomization assignment. Still, clinicians will receive NIDA quick screen results when the patient completes the screener via MyChart.
Primary purpose: SCREENING

Brief summary: This study aims to achieve health equity in substance use disorder (SUD) screening and treatment among Black people living with human immunodeficiency virus (HIV) by implementing interventions to decrease barriers to screening (clinic-based, in-person) and treatment (referral-focused), a program the study investigators call Achieving Equity in Patient Outcome Reporting for Timely Assessments of Life With HIV and Substance Use (ePORTAL HIV-S). The ePORTAL HIV-S randomized control trial will focus on portal-based screening in the HIV clinic, regardless of whether the patient has a scheduled appointment with their HIV provider. The study includes a clinic-based treatment program implemented at the Chicago Department of Public Health-funded South Side Health Home (S2H2), the main provider of HIV prevention and care services for Chicago's South Side.

Detailed description: Substance use disorder (SUD) and human immunodeficiency virus (HIV) are synergistic epidemics (syndemics) disproportionately affecting Black Americans. Structural racism related to inadequate access to healthcare, stigma, and criminalization, especially among those with intersectional identities related to gender and sexual minorities, further exacerbate disparities in HIV and SUD outcomes.

SUD is often unrecognized and untreated among people living with HIV (PLWH). Only about half of HIV care sites routinely screen and refer to SUD treatment. In preliminary work, the study investigators found that nearly half of patients assessed in an HIV clinic waiting room met the criteria for an SUD, but 65% had not been diagnosed with SUD. A promising strategy to address structural barriers to SUD screening for PLWH is use of electronic patient portals. Patient portals are secure websites that give patients access to health information and allow for secure messaging with providers. They are associated with improved health outcomes and patient engagement. Notably, while most SUD screening currently occurs during clinic visits, portals can be utilized for SUD screening to reach patients who miss clinic visits, which is more common among people with HIV and SUD. The study team's preliminary work has demonstrated the potential of the portal for use in a population health approach to behavioral health screening.

This study will implement and evaluate multi-level interventions to decrease barriers to SUD screening (clinic-based, in-person) and treatment (referral-focused), a program the study investigators call Achieving Equity in Patient Outcome Reporting for Timely Assessments of Life With HIV and Substance Use (ePORTAL HIV-S). ePORTAL HIV-S is conducting a randomized control trial to assess the effectiveness of population health vs. usual (clinic-visit) SUD screening among PLWH in an HIV clinic. The randomized control trial will be conducted at the Chicago Department of Public Health-funded South Side Health Home (S2H2), the main provider of HIV prevention and care services for Chicago's South Side. The ePORTAL HIV S study will also include a referral to a clinic-based treatment.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* has been diagnosed with human immunodeficiency virus infection (HIV)
* provider has assented
* receives HIV care at the UCM Ryan White Adult HIV Care Clinic in DCAM, as evidenced by inclusion in the Epic HIV Registry
* speaks English
* has not completed in clinic SUD screening in the last year
* has an active MyChart account

Exclusion Criteria:

* Patients who have been screened for substance use disorder at the clinic in the last year using the NIDA Quick Screen
* Patient's provider has not assented to the intervention
* Patient is younger than 18 years

Primary outcomes:
measure: Percentage of participants screened for substance use disorder
timeFrame: 1 year
Secondary outcomes:
measure: Number and percentage of participants referred to substance use and misuse treatment
timeFrame: 1 year from start
measure: Retention in care in the year post-screening
timeFrame: 2 years from screening start day
measure: HIV viral suppression
timeFrame: 1 year from screening
measure: Number and percentage of participants with moderate or high risk of substance involvement
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jessica P. Ridgway, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Neda Laiteerapong, MD, MS
role: PRINCIPAL_INVESTIGATOR
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