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

Implementing Computerized Substance Use and Depression Screening and Evidence-based Treatments in an HIV Primary Care Population

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; HIV; Substance Use Disorders
• Intervention / Treatment: Behavioral: Clinic-based screening and behavioral interventions

Detailed Description

Substance use disorders (SUDs), anxiety and depression are common among HIV-positive patients and lead to poor HIV treatment outcomes and increased mortality. Yet these disorders often go unrecognized and untreated, despite the availability of effective interventions. To enhance HIV care, this study examines the impact of self-administered tablet-based screening for SUD risk, anxiety and depression using validated measures, with results integrated into the electronic health record and reviewed by behavioral health specialists (BHSs) embedded in primary care HIV clinics. Based on screening results, BHSs will initiate motivational interviewing (MI)- and cognitive behavioral therapy (CBT)-based clinical interventions. Using a hybrid study approach, the investigators will evaluate both implementation and effectiveness of screening and intervention. Specifically, the investigators will employ a stepped-wedge trial design, with a 12-month intervention phase implemented sequentially in the 3 largest HIV primary care clinics serving 5000 HIV-positive patients in Kaiser Permanente Northern California (KPNC), with a 12-month usual care period prior to implementation in each clinic functioning as an observational phase for comparison. This design, a variation of a cross-over RCT, allows for intervention refinement at each clinic and provides the opportunity to compare outcomes among patients before and after implementation. The investigators will evaluate patient-level (e.g., demographics, HIV, SUD, anxiety and depression severity) and provider-level (e.g., provider attitudes) factors affecting implementation and effectiveness, and will analyze cost effectiveness. The results of the study will provide insights regarding the implementation of evidence-based treatments for SUD, anxiety and depression, such as: 1) How self-administered computerized SUD, anxiety and depression screening and corresponding behavioral interventions can be effectively and efficiently implemented in HIV primary care clinics and sustained over time; 2) What patient and clinic characteristics influence screening and intervention rates; 3) To what extent implementation of screening and treatment impacts SUD and depression outcomes, as well as HIV outcomes, including retention in care, viral suppression and Veterans Aging Cohort Study index score, and 4) What are the barriers, facilitators and costs of implementation. The study setting is generalizable to other HIV clinics and health systems and will provide key data regarding the effective delivery of treatment options within primary care settings, and in coordination with SUD and psychiatry specialty care. Furthermore, the study addresses NIH-identified high priority HIV research topics since effective treatment of SUDs and/or depression anxiety would alleviate HIV treatment disparities for these individuals and reduce SUD-, anxiety and depression-related medical comorbidity and mortality.

• Study Type: Interventional
• Enrollment (Actual): 10821
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Division of Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Adult HIV-positive patients who receive services in Kaiser HIV primary care clinics in Oakland, Sacramento, and San Francisco, California.

Description

Inclusion Criteria:

• HIV-positive adults

Exclusion Criteria:

• Patients under age 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-implementation; 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.
Experimental: Post-implementation; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS)	Unadjusted mean change of screening scores for Tobacco, alcohol, and cannabis use from first post intervention screen to second post intervention screen using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) tool. The score ranges from zero - 3 for each substance, zero indicating no use and 2 or higher indicating high-risk, for each substance. 0 = No Use in Past 3 Months, 1 = Problem Use, and 2+ = Higher Risk.	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	Unadjusted mean change of screening scores for depression and anxiety from first post intervention screen to second post intervention screen. The PHQ-9 assesses degree of depression severity. The score ranges from zero - 27 with higher scores indicate higher depression. GAD-2 assesses degree of anxiety severity. The score ranges from zero - 6 with higher scores indicate higher anxiety.	First post intervention screen (1 month) to second post intervention screen (21 months)
HIV Viral Control Change and Substance Use	Change in participants with well controlled HIV RNA by 12 months after newly identified substance use problem	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 in participants with well controlled HIV RNA by 12 months after newly identified mental health problem	change between 24 months prior to clinic-specific implementation date and end of implementation period, up to 21 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute on Alcohol Abuse and Alcoholism (NIAAA); Kaiser Foundation Research Institute
• Investigators: Principal Investigator: Derek Satre, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 13, 2017

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: primary care; digital health; implementation
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Chemically-Induced Disorders; Behavior; Anxiety Disorders; Depression; Substance-Related Disorders; Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy
• Other Study ID Numbers: 16-20272; K24AA025703 (U.S. NIH Grant/Contract); R01DA043139 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No