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

Implementing Computerized Substance Use and Depression Screening and Evidence-based Treatments in an HIV Primary Care Population

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03217058
Acronym
PACE
Enrollment
10821
Registered
2017-07-13
Start date
2016-08-01
Completion date
2020-07-31
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, HIV, Substance Use Disorders

Keywords

digital health, implementation, primary care

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.

Interventions

BEHAVIORALClinic-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.

Sponsors

Kaiser Foundation Research Institute
CollaboratorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Stepped-wedge design evaluating implementation of computerized screening and behavioral interventions delivered by primary care providers.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* HIV-positive adults

Exclusion criteria

* Patients under age 18

Design outcomes

Primary

MeasureTime frameDescription
Change in Mental Health and Substance Use Screening Rates12 months pre-implementation period to the end of the implementation period, up to 21 monthsRate of screening using usual care methods (pre-implementation) compared with rate of screening using computerized methods, based on electronic health record (EHR) data.
Treatment RatePercent treated by 6 months after newly identified substance useInitiation of substance use, anxiety and depression treatment services, based on EHR data

Secondary

MeasureTime frameDescription
Change in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS)First post intervention screen (1 month) to second post intervention screen (21 months)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.
Change in Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder 2-item (GAD-2) ScoresFirst post intervention screen (1 month) to second post intervention screen (21 months)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.
HIV Viral Control Change and Substance Usechange between 24 months prior to clinic-specific implementation date and end of implementation period, up to 21 monthsChange in participants with well controlled HIV RNA by 12 months after newly identified substance use problem
HIV Viral Control Change and Mental Healthchange between 24 months prior to clinic-specific implementation date and end of implementation period, up to 21 monthsChange in participants with well controlled HIV RNA by 12 months after newly identified mental health problem

Countries

United States

Participant flow

Pre-assignment details

Intervention was implemented sequentially at three clinics, starting in Oakland on 10/30/2018, next in Sacramento on 2/1/2019 and finally on 6/1/2019 in San Francisco, and continued until 7/17/2020 in all 3 clinics. In each clinic an observation period of 12 to 24 months prior to implementation was designated as pre-intervention period, depending on the analyses. Analyses were done at the participant level, not at the clinic level, and compared pre- and post-implementation periods.

Participants by arm

ArmCount
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.
5,706
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. 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.
5,115
Total10,821

Baseline characteristics

CharacteristicPost-implementationPre-implementationTotal
Age, Categorical
<=18 years
3 Participants6 Participants9 Participants
Age, Categorical
>=65 years
777 Participants666 Participants1443 Participants
Age, Categorical
Between 18 and 65 years
4335 Participants5034 Participants9369 Participants
CD4 cells
200-350 T cells/ul
378 participants373 participants751 participants
CD4 cells
<200 T cells/ul
198 participants193 participants391 participants
CD4 cells
350-500 T cells/ul
662 participants657 participants1319 participants
CD4 cells
>500 T cells/ul
2900 participants3308 participants6208 participants
CD4 cells
No lab results in prior 365 days
977 participants1175 participants2152 participants
HIV Transmission Risk factor
Heterosexual
601 participants600 participants1201 participants
HIV Transmission Risk factor
IDU
363 participants408 participants771 participants
HIV Transmission Risk factor
MSM
3834 participants4337 participants8171 participants
HIV Transmission Risk factor
Other/Unknown
317 participants361 participants678 participants
Race (NIH/OMB)
American Indian or Alaska Native
27 Participants28 Participants55 Participants
Race (NIH/OMB)
Asian
332 Participants374 Participants706 Participants
Race (NIH/OMB)
Black or African American
993 Participants1022 Participants2015 Participants
Race (NIH/OMB)
More than one race
157 Participants180 Participants337 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
24 Participants25 Participants49 Participants
Race (NIH/OMB)
Unknown or Not Reported
902 Participants954 Participants1856 Participants
Race (NIH/OMB)
White
2680 Participants3123 Participants5803 Participants
Region of Enrollment
United States
5115 participants5706 participants10821 participants
Sex: Female, Male
Female
425 Participants418 Participants843 Participants
Sex: Female, Male
Male
4690 Participants5288 Participants9978 Participants
Study Clinic
Oakland
1528 participants1507 participants3035 participants
Study Clinic
Sacramento
986 participants1011 participants1997 participants
Study Clinic
San Francisco
2601 participants3188 participants5789 participants
Viral load
<200 copies/mL
4356 participants4754 participants9110 participants
Viral load
>=200 copies/mL
341 participants409 participants750 participants
Viral load
No lab results in prior 365 days
418 participants543 participants961 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 5,7060 / 5,115
other
Total, other adverse events
0 / 5,7060 / 5,115
serious
Total, serious adverse events
0 / 5,7060 / 5,115

Outcome results

Primary

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.

Time frame: 12 months pre-implementation period to the end of the implementation period, up to 21 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pre-implementationChange in Mental Health and Substance Use Screening Rates2008 Participants
Post-implementationChange in Mental Health and Substance Use Screening Rates2379 Participants
Primary

Treatment Rate

Initiation of substance use, anxiety and depression treatment services, based on EHR data

Time frame: Percent treated by 6 months after newly identified substance use

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Pre-implementationTreatment RateBHS only136 Participants
Pre-implementationTreatment RateSpecialty Care Only91 Participants
Pre-implementationTreatment RateMedication Only261 Participants
Pre-implementationTreatment RateAny treatment375 Participants
Post-implementationTreatment RateAny treatment83 Participants
Post-implementationTreatment RateMedication Only50 Participants
Post-implementationTreatment RateSpecialty Care Only24 Participants
Post-implementationTreatment RateBHS only26 Participants
Post-implementation (Survey)Treatment RateSpecialty Care Only22 Participants
Post-implementation (Survey)Treatment RateAny treatment194 Participants
Post-implementation (Survey)Treatment RateMedication Only127 Participants
Post-implementation (Survey)Treatment RateBHS only75 Participants
Primary

Treatment Rate

Initiation of substance use, anxiety and depression treatment services, based on EHR data

Time frame: Percent treated by 6 months after newly identified mental health problem

ArmMeasureGroupValue (NUMBER)
Pre-implementationTreatment RateAny treatment1079 participants
Pre-implementationTreatment RateMedication Only962 participants
Pre-implementationTreatment RateBHS only221 participants
Pre-implementationTreatment RateSpecialty Care Only455 participants
Post-implementationTreatment RateSpecialty Care Only95 participants
Post-implementationTreatment RateAny treatment249 participants
Post-implementationTreatment RateBHS only44 participants
Post-implementationTreatment RateMedication Only228 participants
Post-implementation (Survey)Treatment RateSpecialty Care Only90 participants
Post-implementation (Survey)Treatment RateMedication Only191 participants
Post-implementation (Survey)Treatment RateBHS only49 participants
Post-implementation (Survey)Treatment RateAny treatment226 participants
Secondary

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.

Time frame: First post intervention screen (1 month) to second post intervention screen (21 months)

Population: Of 2,865 people with HIV screened across all three clinics post-intervention, 403 screened positive at first screen AND completed a follow-up screen.

ArmMeasureGroupValue (MEAN)
Pre-implementationChange in Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder 2-item (GAD-2) ScoresDepression (GAD-2)-5.25 scores on a scale
Pre-implementationChange in Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder 2-item (GAD-2) ScoresAnxiety (PHQ9)-1.42 scores on a scale
Secondary

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.

Time frame: First post intervention screen (1 month) to second post intervention screen (21 months)

Population: Of 2,865 people with HIV screened across all three clinics post-intervention, 403 screened positive at first screen AND completed a follow-up screen.

ArmMeasureGroupValue (MEAN)
Pre-implementationChange in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS)Tobacco-0.36 scores on a scale
Pre-implementationChange in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS)Alcohol-0.72 scores on a scale
Pre-implementationChange in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS)Cannabis-0.61 scores on a scale
Secondary

HIV Viral Control Change and Mental Health

Change in participants with well controlled HIV RNA by 12 months after newly identified mental health problem

Time frame: change between 24 months prior to clinic-specific implementation date and end of implementation period, up to 21 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pre-implementationHIV Viral Control Change and Mental Health990 Participants
Post-implementationHIV Viral Control Change and Mental Health240 Participants
Post-implementation (Survey)HIV Viral Control Change and Mental Health253 Participants
Secondary

HIV Viral Control Change and Substance Use

Change in participants with well controlled HIV RNA by 12 months after newly identified substance use problem

Time frame: change between 24 months prior to clinic-specific implementation date and end of implementation period, up to 21 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pre-implementationHIV Viral Control Change and Substance Use867 Participants
Post-implementationHIV Viral Control Change and Substance Use164 Participants
Post-implementation (Survey)HIV Viral Control Change and Substance Use551 Participants

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026