Substance Use DisordersPACENCT03217058
Computerized Substance Use and Depression Screening and Behavioral Treatment in HIV Primary Care
A study testing Clinic-based screening and behavioral interventions in people with Substance Use Disorders and HIV, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Substance Use Disorders, HIV, Depression
- What is being tested?
- Clinic-based screening and behavioral interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,821 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV-positive adults
Who cannot join
- Patients under age 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Division of Research
Oakland, California, 94612
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Use Disorders, HIV, Depression, Anxiety
- Being tested
- Clinic-based screening and behavioral interventions
- Keywords
- digital health, implementation, primary care
- Medical subject headings
- Substance-Related Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic-based screening and behavioral interventionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation | No intervention | 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 | Experimental | 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. Receives: Behavioral: Clinic-based screening and behavioral interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mental Health and Substance Use Screening Rates
Rate of screening using usual care methods (pre-implementation) compared with rate of screening using computerized methods, based on electronic health record (EHR) data.
Measured: 12 months pre-implementation period to the end of the implementation period, up to 21 months
Treatment Rate
Initiation of substance use, anxiety and depression treatment services, based on EHR data
Measured: Percent treated by 6 months after newly identified substance use
Treatment Rate
Initiation of substance use, anxiety and depression treatment services, based on EHR data
Measured: Percent treated by 6 months after newly identified mental health problem
Secondary outcomes (4)
Change in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS)
Unadjusted mean change of screening scores for Tobacco, alcohol, and cannabis use from first post intervention screen to second post intervention screen using the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) tool. The score ranges from zero - 3 for each substance, zero indicating no use and 2 or higher indicating high-risk, for each substance. 0 = No Use in Past 3 Months, 1 = Problem Use, and 2+ = Higher Risk.
Measured: 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
Unadjusted mean change of screening scores for depression and anxiety from first post intervention screen to second post intervention screen.
The PHQ-9 assesses degree of depression severity. The score ranges from zero - 27 with higher scores indicate higher depression.
GAD-2 assesses degree of anxiety severity. The score ranges from zero - 6 with higher scores indicate higher anxiety.
Measured: First post intervention screen (1 month) to second post intervention screen (21 months)
HIV Viral Control Change and Substance Use
Change in participants with well controlled HIV RNA by 12 months after newly identified substance use problem
Measured: 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 in participants with well controlled HIV RNA by 12 months after newly identified mental health problem
Measured: change between 24 months prior to clinic-specific implementation date and end of implementation period, up to 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start1 Aug 2016
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Stepped-wedge design evaluating implementation of computerized screening and behavioral interventions delivered by primary care providers.
- Masking
- None (open label)
- Enrolment
- 10,821 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Foundation Research Institute, National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Derek Satre, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217058
- Sponsor's protocol ID
- 16-20272
- Other IDs
- K24AA025703, R01DA043139
- Acronym
- PACE
- Status last verified
- Sep 2025
- First submitted
- 7 Jul 2017
- Last updated
- 7 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lea AN, Levine TM, Davy-Mendez T, Leibowitz A, Altschuler A, Flamm J, Hare CB, N Luu M, Silverberg MJ, Satre DD. Mental health and substance use screening in HIV primary care before and during the early COVID-19 pandemic. BMC Health Serv Res. 2023 May 16;23(1):494. doi: 10.1186/s12913-023-09477-6.
PubMed 37194051Lea 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.
PubMed 35139911Satre 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.
PubMed 31446142
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Computerized Substance Use and Depression Screening and Evidence-based Treatments in an HIV Primary Care Population
- ClinicalTrials.gov ID
- NCT03217058
- Acronym / sponsor ID
- PACE / 16-20272
- Conditions
- Substance Use Disorders, HIV, Depression, Anxiety
- Keywords
- digital health, implementation, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,821 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Kaiser Foundation Research Institute, National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 13 Jul 2017 (actual)
- Results
- Posted 7 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge design evaluating implementation of computerized screening and behavioral interventions delivered by primary care providers.
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation | No intervention | –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 | Experimental | Behavioral: Clinic-based screening and behavioral interventionsThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- HIV-positive adults
Key exclusion criteria (1 listed)
- Patients under age 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinic-based screening and behavioral interventionsAs 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. | Behavioural | Post-implementation |
Primary outcome
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 substance use
Initiation of substance use, anxiety and depression treatment services, based on 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
4 secondary outcomes
Change in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS)
Time frame: 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
Time frame: First post intervention screen (1 month) to second post intervention screen (21 months)
HIV Viral Control Change and Substance Use
Time frame: 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
Time frame: change between 24 months prior to clinic-specific implementation date and end of implementation period, up to 21 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37194051Lea AN, Levine TM, Davy-Mendez T, Leibowitz A, Altschuler A, Flamm J, Hare CB, N Luu M, Silverberg MJ, Satre DD. Mental health and substance use screening in HIV primary care before and during the early COVID-19 pandemic. BMC Health Serv Res. 2023 May 16;23(1):494. doi: 10.1186/s12913-023-09477-6.
- Derived from this study: PubMed 35139911Lea 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.
- Derived from this study: PubMed 31446142Satre 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Satre, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinic-based screening and behavioral interventions in people with Substance Use Disorders and HIV, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03217058, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025; AzTrials last refreshed its copy on 31 Oct 2026.