- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03217058
Computerized Substance Use and Depression Screening and Behavioral Treatment in HIV Primary Care (PACE)
November 29, 2023 updated by: University of California, San Francisco
Implementing Computerized Substance Use and Depression Screening and Evidence-based Treatments in an HIV Primary Care Population
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
2829
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Oakland, California, United States, 94612
- Kaiser Permanente Division of Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Study Population
Adult HIV-positive patients who receive services in Kaiser HIV primary care clinics in Oakland, Sacramento, and San Francisco, California.
Description
Inclusion Criteria:
- HIV-positive adults
Exclusion Criteria:
- Patients under age 18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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.
|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change between one year prior to implementation and one year post-implementation
|
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
|
Change between one year prior to implementation and one year post-implementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change between one year prior to implementation and one year post-implementation
|
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
|
Change between one year prior to implementation and one year post-implementation
|
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
|
Change between one year prior to implementation and one year post-implementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Derek Satre, PhD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2017
Primary Completion (Actual)
July 31, 2020
Study Completion (Actual)
July 31, 2020
Study Registration Dates
First Submitted
July 7, 2017
First Submitted That Met QC Criteria
July 12, 2017
First Posted (Actual)
July 13, 2017
Study Record Updates
Last Update Posted (Estimated)
December 6, 2023
Last Update Submitted That Met QC Criteria
November 29, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-20272
- K24AA025703 (U.S. NIH Grant/Contract)
- R01DA043139 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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