Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03217058
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Kaiser Foundation Research Institute
Information provided by (Responsible Party):
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.

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety HIV/AIDS

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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217058


Contacts
Layout table for location contacts
Contact: Derek Satre, PhD 415-476-7382 derek.satre@ucsf.edu

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Derek Satre, PhD University of California, San Francisco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03217058    
Other Study ID Numbers: 16-20272
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Layout table for MeSH terms
Substance-Related Disorders
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Chemically-Induced Disorders