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

NCT06682468 | Active Not Recruiting DMC

• 2 other identifiers: IRB24-0684R01DA058965
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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 "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.

Conditions

HIV; Substance Use Disorders

Keywords

People Living with HIV; Screening; Substance Use Disorder Screening

Outcome Measures

Primary Outcomes (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.

  1 year from screening start date

Secondary Outcomes (4)

• Number and percentage of participants referred to substance use and misuse treatment

  1 year from screening start date

• Retention in care in the year post-screening

  2 years from screening start date

• HIV viral suppression

  1 year from screening start date

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

  1 year from screening start date

Study Arms (2)

Patient portal population level substance involvement risk screener

EXPERIMENTAL

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

Usual Care SUD Screening

OTHER

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

Interventions

Usual Care Substance Use Involvement Screening BEHAVIORAL

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.

Usual Care SUD Screening

Population level patient portal based substance involvement screening BEHAVIORAL

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.

Patient portal population level substance involvement risk screener

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• has been diagnosed with human immunodeficiency virus infection (HIV)
• provider has assented
• speaks English
• has not completed in clinic SUD screening in the last year
• has an active MyChart account

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Related Publications (14)

• 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.

  PMID: 20625025 BACKGROUND

• 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.

  PMID: 33830178 BACKGROUND

• 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.

  PMID: 36127535 BACKGROUND

• 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.

  PMID: 32568720 BACKGROUND

• 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.

  PMID: 33669439 BACKGROUND

• 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.

  PMID: 19074303 BACKGROUND

• 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.

  PMID: 33779423 BACKGROUND

• 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.

  PMID: 31846348 BACKGROUND

• 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.

  PMID: 23242158 BACKGROUND

• 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.

  PMID: 33506305 BACKGROUND

• 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.

  PMID: 33323072 BACKGROUND

• 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.

  PMID: 31414355 BACKGROUND

• 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.

  PMID: 32853246 BACKGROUND

• 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.

  PMID: 40927331 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jessica P. Ridgway, MD, MS

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Neda Laiteerapong, MD, MS

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patient randomization will be completed by an honest broker and blinded to the research team.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: November 12, 2024
• Study Start: February 12, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)