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Clinical Trials/NCT03217058
NCT03217058
Completed
Not Applicable

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

University of California, San Francisco1 site in 1 country10,821 target enrollmentAugust 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use Disorders
Sponsor
University of California, San Francisco
Enrollment
10821
Locations
1
Primary Endpoint
Change in Mental Health and Substance Use Screening Rates
Status
Completed
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2016
End Date
July 31, 2020
Last Updated
6 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • HIV-positive adults

Exclusion Criteria

  • Patients under age 18

Outcomes

Primary Outcomes

Change in Mental Health and Substance Use Screening Rates

Time Frame: 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

Time Frame: 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 Outcomes

  • 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 Sites (1)

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