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Substance Use DisordersePORTAL-HIV-SNCT06682468

Achieving Equity in Patient Outcome Reporting for Timely Assessments of Life With HIV and Substance Use

A study testing Population level patient portal based substance involvement screening in people with Substance Use Disorders and HIV, run by University of Chicago at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Substance Use Disorders, HIV
What is being tested?
Population level patient portal based substance involvement screening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
1 siteUnited States
Study dates
12 Feb 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Chicago Medicine

    Chicago, Illinois, 60637

Other trials in United States

About this study

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.

Read the 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.

Being tested
Population level patient portal based substance involvement screening, Usual Care Substance Use Involvement Screening
Keywords
People Living with HIV, Screening, Substance Use Disorder Screening
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Population level patient portal based substance involvement screeningBehavioural

    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.

  • Usual Care Substance Use Involvement ScreeningBehavioural

    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.

Study groups in NCT06682468
Study groupRoleWhat they receive
Patient portal population level substance involvement risk screenerExperimentalParticipants 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.
Receives: Behavioral: Population level patient portal based substance involvement screening
Usual Care SUD ScreeningOtherParticipants randomized to this intervention will receive the NIDA Quick Screen V1.0 if they attend their scheduled appointment with their HIV clinician.
Receives: Behavioral: Usual Care Substance Use Involvement Screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants screened for substance use disorder

    Percentage of participants who completed the validated NIDA Quick Screen V1.0 for substance use disorder in the HIV clinic.

    Measured: 1 year from screening start date

Secondary outcomes (4)
  1. Number and percentage of participants referred to substance use and misuse treatment

    # of participants referred to substance use and misuse treatment / # of participants diagnosed with moderate or high risk of substance use involvement

    Measured: 1 year from screening start date

  2. Retention in care in the year post-screening

    # of participants who attended HIV care clinic visit in the year after completing the NIDA Quick Screen V1.0

    Measured: 2 years from screening start date

  3. HIV viral suppression

    Participants' labs of HIV viral load measurements

    Measured: 1 year from screening start date

  4. Number and percentage of participants with moderate or high risk of substance involvement

    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.

    Measured: 1 year from screening start date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start12 Feb 2025
  3. Primary completionJun 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be enrolled into two groups: 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.
Masking
Single blind
Who is masked
Investigator
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06682468
Sponsor's protocol ID
IRB24-0684
Other IDs
R01DA058965
Acronym
ePORTAL-HIV-S
Status last verified
Mar 2026
First submitted
27 Sep 2024
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a clinic-level intervention study. Research team will only receive a limited data set with no individual participant data.

Publications

  • Smith PC, Schmidt SM, Allensworth-Davies D, Saitz R. A single-question screening test for drug use in primary care. Arch Intern Med. 2010 Jul 12;170(13):1155-60. doi: 10.1001/archinternmed.2010.140.

    PubMed 20625025
  • Sinha S, Garriga M, Naik N, McSteen BW, Odisho AY, Lin A, Hong JC. Disparities in Electronic Health Record Patient Portal Enrollment Among Oncology Patients. JAMA Oncol. 2021 Jun 1;7(6):935-937. doi: 10.1001/jamaoncol.2021.0540.

    PubMed 33830178
  • Franco MI, Staab EM, Zhu M, Knitter A, Wan W, Gibbons R, Vinci L, Shah S, Yohanna D, Beckman N, Laiteerapong N. Pragmatic Clinical Trial of Population Health, Portal-Based Depression Screening: the PORTAL-Depression Study. J Gen Intern Med. 2023 Mar;38(4):857-864. doi: 10.1007/s11606-022-07779-9. Epub 2022 Sep 20.

    PubMed 36127535
  • Lee SB, Valerius J. mHealth Interventions to Promote Anti-Retroviral Adherence in HIV: Narrative Review. JMIR Mhealth Uhealth. 2020 Aug 28;8(8):e14739. doi: 10.2196/14739.

    PubMed 32568720
  • Chu D, Schuster T, Lessard D, Mate K, Engler K, Ma Y, Abulkhir A, Arora A, Long S, de Pokomandy A, Lacombe K, Rougier H, Cox J, Kronfli N, Hijal T, Kildea J, Routy JP, Asselah J, Lebouche B. Acceptability of a Patient Portal (Opal) in HIV Clinical Care: A Feasibility Study. J Pers Med. 2021 Feb 16;11(2):134. doi: 10.3390/jpm11020134.

    PubMed 33669439
  • Byrne JM, Elliott S, Firek A. Initial experience with patient-clinician secure messaging at a VA medical center. J Am Med Inform Assoc. 2009 Mar-Apr;16(2):267-70. doi: 10.1197/jamia.M2835. Epub 2008 Dec 11.

    PubMed 19074303
  • Judd RT, Friedman EE, Schmitt J, Ridgway JP. Association between patient-reported barriers and HIV clinic appointment attendance: A prospective cohort study. AIDS Care. 2022 May;34(5):545-553. doi: 10.1080/09540121.2021.1906401. Epub 2021 Mar 28.

    PubMed 33779423
  • Bockting W, MacCrate C, Israel H, Mantell JE, Remien RH. Engagement and Retention in HIV Care for Transgender Women: Perspectives of Medical and Social Service Providers in New York City. AIDS Patient Care STDS. 2020 Jan;34(1):16-26. doi: 10.1089/apc.2019.0067. Epub 2019 Dec 17.

    PubMed 31846348
  • Rebeiro P, Althoff KN, Buchacz K, Gill J, Horberg M, Krentz H, Moore R, Sterling TR, Brooks JT, Gebo KA, Hogg R, Klein M, Martin J, Mugavero M, Rourke S, Silverberg MJ, Thorne J, Gange SJ; North American AIDS Cohort Collaboration on Research and Design. Retention among North American HIV-infected persons in clinical care, 2000-2008. J Acquir Immune Defic Syndr. 2013 Mar 1;62(3):356-62. doi: 10.1097/QAI.0b013e31827f578a.

    PubMed 23242158
  • Vetrova MV, Cheng DM, Bendiks S, Gnatienko N, Lloyd-Travaglini C, Jiang W, Luoma J, Blokhina E, Krupitsky E, Lioznov D, Ekstrand ML, Raj A, Samet JH, Lunze K. HIV and Substance Use Stigma, Intersectional Stigma and Healthcare Among HIV-Positive PWID in Russia. AIDS Behav. 2021 Sep;25(9):2815-2826. doi: 10.1007/s10461-021-03172-5. Epub 2021 Jan 28.

    PubMed 33506305
  • Myers K, Li T, Baum M, Ibanez G, Fennie K. The individual, interactive, and syndemic effect of substance use, depression, education, and ethnicity on retention in HIV care. Int J STD AIDS. 2021 Feb;32(2):184-193. doi: 10.1177/0956462419890727. Epub 2020 Dec 15.

    PubMed 33323072
  • Saunders EC, Moore SK, Gardner T, Farkas S, Marsch LA, McLeman B, Meier A, Nesin N, Rotrosen J, Walsh O, McNeely J. Screening for Substance Use in Rural Primary Care: a Qualitative Study of Providers and Patients. J Gen Intern Med. 2019 Dec;34(12):2824-2832. doi: 10.1007/s11606-019-05232-y.

    PubMed 31414355
  • Parcesepe AM, Lancaster K, Edelman EJ, DeBoni R, Ross J, Atwoli L, Tlali M, Althoff K, Tine J, Duda SN, Wester CW, Nash D; IeDEA Consortium. Substance use service availability in HIV treatment programs: Data from the global IeDEA consortium, 2014-2015 and 2017. PLoS One. 2020 Aug 27;15(8):e0237772. doi: 10.1371/journal.pone.0237772. eCollection 2020.

    PubMed 32853246
  • Roessler E, Zimmer D, Grant J, Pollack H, Boodram B, Schmitt J, Friedman E, Pagkas-Bather J, Brewer RA, Ridgway J, Laiteerapong N. Protocol for a randomized controlled trial of patient-portal-based screening for substance use among people with HIV. Front Public Health. 2025 Aug 20;13:1583546. doi: 10.3389/fpubh.2025.1583546. eCollection 2025.

    PubMed 40927331

Questions about this trial

What is this clinical trial studying?

A study testing Population level patient portal based substance involvement screening in people with Substance Use Disorders and HIV, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants screened for substance use disorder (time frame: 1 year from screening start date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06682468, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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