Achieving Equity in Patient Outcome Reporting for Timely Assessments of Life With HIV and Substance Use (ePORTAL-HIV-S)

March 6, 2026 updated by: University of Chicago
This study aims to achieve health equity in substance use disorder (SUD) screening and treatment among 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 a HIV clinic waiting room met the criteria for a 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 a HIV clinic.

Study Type

Interventional

Enrollment (Estimated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years or older
  • has been diagnosed with human immunodeficiency virus infection (HIV)
  • provider has assented
  • receives HIV care at the University of Chicago Ryan White Adult HIV Care Clinic, 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Usual Care SUD Screening
Participants randomized to this intervention will receive the NIDA Quick Screen V1.0 if they attend their scheduled appointment with their HIV clinician.
Behavioral: Usual Care Substance Use Involvement Screening
Participants randomized to the usual care group will receive the validated NIDA Quick Screen V1.0 during routine in-clinic visits if they attend their scheduled visit. The medical assistant will ask participants to complete the NIDA Quick Screen V1.0. Participants who endorse the use of illegal drugs or prescription drugs for non-medical reasons, tobacco use, or heavy drinking will be referred to SUD treatment.
Experimental: Patient portal population level substance involvement risk screener
Participants randomized to this group will receive a NIDA Quick Screen V1.0 substance involvement screener over the patient portal regardless of having a scheduled appointment with their HIV clinician. If they do not complete the screener via the portal, they will be screened at HIV clinic appointments.
Behavioral: Population level patient portal based substance involvement screening
Participants 18 years or older, with an active patient portal account, who have attended a HIV care clinic visit in the HIV clinic in the last two years and have not completed the validated NIDA Quick Screen V1.0 in the previous year will be eligible for intervention randomization. Those randomized into the intervention group will receive the validated NIDA Quick Screen V1.0 over their patient portal account. Participants randomized to this group can complete the screener over the patient portal without a scheduled appointment with their HIV clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants screened for substance use disorder
Time Frame: 1 year from screening start date
Percentage of participants who completed the validated NIDA Quick Screen V1.0 for substance use disorder in the HIV clinic.
1 year from screening start date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and percentage of participants referred to substance use and misuse treatment
Time Frame: 1 year from screening start date
# of participants referred to substance use and misuse treatment / # of participants diagnosed with moderate or high risk of substance use involvement
1 year from screening start date
Retention in care in the year post-screening
Time Frame: 2 years from screening start date
# of participants who attended HIV care clinic visit in the year after completing the NIDA Quick Screen V1.0
2 years from screening start date
HIV viral suppression
Time Frame: 1 year from screening start date
Participants' labs of HIV viral load measurements
1 year from screening start date
Number and percentage of participants with moderate or high risk of substance involvement
Time Frame: 1 year from screening start date
The number and percentage of participants who receive a score of 4 or higher in illicit substance use, say "Yes" to one or more days of heavy drinking, or endorse tobacco use, indicating moderate or high risk of substance involvement measured by the NIDA Quick Screen V1.0.
1 year from screening start date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Neda Laiteerapong, MD, MS, University of Chicago
  • Principal Investigator: Jessica P. Ridgway, MD, MS, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

November 7, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB24-0684
  • R01DA058965 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a clinic-level intervention study. Research team will only receive a limited data set with no individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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