Computerized Substance Use and Depression Screening and Behavioral Treatment in HIV Primary Care

NCT03217058 | Completed Results

• 3 other identifiers: 16-20272K24AA025703R01DA043139
• Study Type: interventional
• Target: 10,821
• Locations: 1 country
• Sites: 1

Brief Summary

Substance use disorders (SUDs), depression and anxiety in HIV-infected patients result in poor HIV outcomes, yet are often unrecognized and untreated. To address these problems, this study examines the implementation and effectiveness of a clinical intervention consisting of self-administered tablet-based SUD and depression screening at routine HIV primary care clinic visits, followed by evidence-based treatments for SUD, anxiety and depression delivered by a behavioral health specialist. If successful, this study has potential to reduce SUD-, anxiety- and depression-related problems and reduce HIV treatment disparities for patients with these comorbidities.

Conditions

Substance Use Disorders; HIV; Depression; Anxiety

Keywords

digital health; implementation; primary care

Outcome Measures

Primary Outcomes (3)

• Change in Mental Health and Substance Use Screening Rates

  Rate of screening using usual care methods (pre-implementation) compared with rate of screening using computerized methods, based on electronic health record (EHR) data.

  12 months pre-implementation period to the end of the implementation period, up to 21 months

• Treatment Rate

  Initiation of substance use, anxiety and depression treatment services, based on EHR data

  Percent treated by 6 months after newly identified substance use

• Treatment Rate

  Initiation of substance use, anxiety and depression treatment services, based on EHR data

  Percent treated by 6 months after newly identified mental health problem

Secondary Outcomes (4)

• Change in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS)

  First post intervention screen (1 month) to second post intervention screen (21 months)

• Change in Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder 2-item (GAD-2) Scores

  First post intervention screen (1 month) to second post intervention screen (21 months)

• HIV Viral Control Change and Substance Use

  change between 24 months prior to clinic-specific implementation date and end of implementation period, up to 21 months

• HIV Viral Control Change and Mental Health

  change between 24 months prior to clinic-specific implementation date and end of implementation period, up to 21 months

Study Arms (2)

Pre-implementation

NO INTERVENTION

The pre-implementation cohort includes data from 5000 HIV primary care clinic patients in Kaiser Permanente Northern California, who receive services prior to implementation of computerized screening and behavioral intervention in the clinics.

Post-implementation

EXPERIMENTAL

The post-implementation cohort includes data from 5000 HIV primary care clinic patients in Kaiser Permanente Northern California, who receive services after computerized screening and behavioral intervention have been implemented in the clinics.

Behavioral: Clinic-based screening and behavioral interventions

Interventions

Clinic-based screening and behavioral interventions BEHAVIORAL

As part of routine HIV primary care visits, patients will complete self-administered computerized substance use, anxiety and depression screening measures. Results will be integrated into the electronic health record. A behavioral health specialist on the clinic staff will contact patients who screen positive for high-risk substance use, anxiety or depression, and offer behavioral interventions including motivational interviewing and cognitive behavioral therapy.

Post-implementation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-positive adults

You may not qualify if:

• Patients under age 18

Sponsors & Collaborators

• University of California, San Francisco: lead
• Kaiser Foundation Research Institute: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Kaiser Permanente Division of Research

Oakland, California, 94612, United States

Location

Related Publications (3)

• Lea AN, Levine TM, Davy-Mendez T, Leibowitz A, Altschuler A, Flamm J, Hare CB, N Luu M, Silverberg MJ, Satre DD. Mental health and substance use screening in HIV primary care before and during the early COVID-19 pandemic. BMC Health Serv Res. 2023 May 16;23(1):494. doi: 10.1186/s12913-023-09477-6.

  PMID: 37194051 DERIVED

• Lea AN, Altschuler A, Leibowitz AS, Levine-Hall T, McNeely J, Silverberg MJ, Satre DD. Patient and provider perspectives on self-administered electronic substance use and mental health screening in HIV primary care. Addict Sci Clin Pract. 2022 Feb 9;17(1):10. doi: 10.1186/s13722-022-00293-7.

  PMID: 35139911 DERIVED

• Satre DD, Anderson AN, Leibowitz AS, Levine-Hall T, Slome S, Flamm J, Hare CB, McNeely J, Weisner CM, Horberg MA, Volberding P, Silverberg MJ. Implementing electronic substance use disorder and depression and anxiety screening and behavioral interventions in primary care clinics serving people with HIV: Protocol for the Promoting Access to Care Engagement (PACE) trial. Contemp Clin Trials. 2019 Sep;84:105833. doi: 10.1016/j.cct.2019.105833. Epub 2019 Aug 22.

  PMID: 31446142 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Depression; Anxiety Disorders

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Derek Satre, Principal Investigator
• Organization: University of California San Francisco

Derek.Satre@ucsf.edu

415-476-7382

Study Officials

• Derek Satre, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge design evaluating implementation of computerized screening and behavioral interventions delivered by primary care providers.

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 13, 2017
• Study Start: August 1, 2016
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: October 7, 2025
• Results First Posted: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)