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

Not Applicable

Completed

Conditions: Depression
Substance Use Disorders
Anxiety
HIV

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10821

Inclusion Criteria

HIV-positive adults

Exclusion Criteria

Patients under age 18

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Change in Mental Health and Substance Use Screening Rates	12 months pre-implementation period to the end of the implementation period, up to 21 months	Rate of screening using usual care methods (pre-implementation) compared with rate of screening using computerized methods, based on electronic health record (EHR) data.
Treatment Rate	Percent treated by 6 months after newly identified mental health problem	Initiation of substance use, anxiety and depression treatment services, based on EHR data

Secondary Outcome Measures

Name	Time	Method
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)	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.
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)	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.
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	Change in participants with well controlled HIV RNA by 12 months after newly identified substance use problem
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	Change in participants with well controlled HIV RNA by 12 months after newly identified mental health problem

Trial Locations

Locations (1): Kaiser Permanente Division of Research
🇺🇸
Oakland, California, United States
Kaiser Permanente Division of Research
🇺🇸Oakland, California, United States