Clinical trial NCT03217058: Computerized Substance Use and Depression Screening and Behavioral Treatment in HIV Primary Care
Official title: Implementing Computerized Substance Use and Depression Screening and Evidence-based Treatments in an HIV Primary Care Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
HIV
Depression
Anxiety
Keywords: digital health
implementation
primary care
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Kaiser Foundation Research Institute
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: National Institute on Drug Abuse (NIDA)
First posted: 2017-07-13
Enrollment: 2829
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge design evaluating implementation of computerized screening and behavioral interventions delivered by primary care providers.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* HIV-positive adults

Exclusion Criteria:

* Patients under age 18

Primary outcomes:
measure: Screening rate
timeFrame: Change between one year prior to implementation and one year post-implementation
measure: Treatment rate
timeFrame: Change between one year prior to implementation and one year post-implementation
Secondary outcomes:
measure: HIV viral control
timeFrame: Change between one year prior to implementation and one year post-implementation
measure: Substance use severity
timeFrame: Change between one year prior to implementation and one year post-implementation
measure: Depression and anxiety severity
timeFrame: Change between one year prior to implementation and one year post-implementation
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Division of Research
state: California
Study officials:
affiliation: University of California, San Francisco
name: Derek Satre, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.