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

Not Applicable

Completed

• Conditions: Depression; Substance Use Disorders; Anxiety; HIV
• Interventions: Behavioral: Clinic-based screening and behavioral interventions

• Registration Number: NCT03217058
• Lead Sponsor: University of California, San Francisco

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.

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 Timeline

• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-13
• Study Start: 2017-08-01
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2829

Inclusion Criteria

• HIV-positive adults

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Exclusion Criteria

• Patients under age 18

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Post-implementation	Clinic-based screening and behavioral interventions	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.

Primary Outcome Measures

Name	Time	Method
Treatment rate	Change between one year prior to implementation and one year post-implementation	Initiation of substance use, anxiety and depression treatment services, based on EHR data
Screening rate	Change between one year prior to implementation and one year post-implementation	Rate of screening using usual care methods (pre-implementation) compared with rate of screening using computerized methods, based on electronic health record (EHR) data.

Secondary Outcome Measures

Name	Time	Method
Substance use severity	Change between one year prior to implementation and one year post-implementation	Substance use severity as recorded in EHR screening measures
Depression and anxiety severity	Change between one year prior to implementation and one year post-implementation	Depression and anxiety severity as recorded in EHR screening measures
HIV viral control	Change between one year prior to implementation and one year post-implementation	HIV RNA viral control before and after implementation of computerized screening and behavioral interventions for substance use and depression, based on EHR data.

Trial Locations

Locations (1)

Kaiser Permanente Division of Research; 🇺🇸 Oakland, California, United States