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

• ClinicalTrials.gov Identifier: NCT03217058
• Recruitment Status: Recruiting
• First Posted: July 13, 2017
• Last Update Posted: November 4, 2020
• Sponsor: University of California, San Francisco
• Collaborator: Kaiser Foundation Research Institute
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment
Substance Use Disorders; HIV; Depression; Anxiety	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 Design

• Study Type: Observational
• Estimated Enrollment: 5000 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Implementing Computerized Substance Use and Depression Screening and Evidence-based Treatments in an HIV Primary Care Population
• Actual Study Start Date: August 1, 2017
• Actual Primary Completion Date: August 1, 2020
• Estimated Study Completion Date: February 1, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

1. Screening rate [ Time Frame: 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.
2. Treatment rate [ Time Frame: 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

Secondary Outcome Measures :

1. HIV viral control [ Time Frame: 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.
2. Substance use severity [ Time Frame: Change between one year prior to implementation and one year post-implementation ]
   Substance use severity as recorded in EHR screening measures
3. Depression and anxiety severity [ Time Frame: Change between one year prior to implementation and one year post-implementation ]
   Depression and anxiety severity as recorded in EHR screening measures

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

• HIV-positive adults

Exclusion Criteria:

• Patients under age 18

Contacts and Locations

Contacts

Contact: Derek Satre, PhD; 415-476-7382; derek.satre@ucsf.edu

Locations

United States, California

Kaiser Permanente Division of Research; Recruiting

Oakland, California, United States, 94612

Contact: Michael J Silverberg, PhD 510-891-3801 Michael.J.Silverberg@kp.org

Sponsors and Collaborators

University of California, San Francisco

Kaiser Foundation Research Institute

Investigators

• Principal Investigator: Derek Satre, PhD; University of California, San Francisco

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03217058
• Other Study ID Numbers: 16-20272
• First Posted: July 13, 2017
• Last Update Posted: November 4, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:

digital health; implementation; primary care

Additional relevant MeSH terms:

Substance-Related Disorders; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Chemically-Induced Disorders