Anxiety, Depression, HIV, Substance Use Disorders
Conditions
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
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
Study design
Intervention model description
Stepped-wedge design evaluating implementation of computerized screening and behavioral interventions delivered by primary care providers.
Eligibility
Inclusion criteria
* HIV-positive adults
Exclusion criteria
* Patients under age 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mental Health and Substance Use Screening Rates | 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 | Percent treated by 6 months after newly identified substance use | Initiation of substance use, anxiety and depression treatment services, based on EHR data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) Scores | First 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 Use | change between 24 months prior to clinic-specific implementation date and end of implementation period, up to 21 months | Change in participants with well controlled HIV RNA by 12 months after newly identified substance use problem |
| HIV Viral Control Change and Mental Health | change between 24 months prior to clinic-specific implementation date and end of implementation period, up to 21 months | Change 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
| Arm | Count |
|---|---|
| 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 |
| Total | 10,821 |
Baseline characteristics
| Characteristic | Post-implementation | Pre-implementation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 6 Participants | 9 Participants |
| Age, Categorical >=65 years | 777 Participants | 666 Participants | 1443 Participants |
| Age, Categorical Between 18 and 65 years | 4335 Participants | 5034 Participants | 9369 Participants |
| CD4 cells 200-350 T cells/ul | 378 participants | 373 participants | 751 participants |
| CD4 cells <200 T cells/ul | 198 participants | 193 participants | 391 participants |
| CD4 cells 350-500 T cells/ul | 662 participants | 657 participants | 1319 participants |
| CD4 cells >500 T cells/ul | 2900 participants | 3308 participants | 6208 participants |
| CD4 cells No lab results in prior 365 days | 977 participants | 1175 participants | 2152 participants |
| HIV Transmission Risk factor Heterosexual | 601 participants | 600 participants | 1201 participants |
| HIV Transmission Risk factor IDU | 363 participants | 408 participants | 771 participants |
| HIV Transmission Risk factor MSM | 3834 participants | 4337 participants | 8171 participants |
| HIV Transmission Risk factor Other/Unknown | 317 participants | 361 participants | 678 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 27 Participants | 28 Participants | 55 Participants |
| Race (NIH/OMB) Asian | 332 Participants | 374 Participants | 706 Participants |
| Race (NIH/OMB) Black or African American | 993 Participants | 1022 Participants | 2015 Participants |
| Race (NIH/OMB) More than one race | 157 Participants | 180 Participants | 337 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 24 Participants | 25 Participants | 49 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 902 Participants | 954 Participants | 1856 Participants |
| Race (NIH/OMB) White | 2680 Participants | 3123 Participants | 5803 Participants |
| Region of Enrollment United States | 5115 participants | 5706 participants | 10821 participants |
| Sex: Female, Male Female | 425 Participants | 418 Participants | 843 Participants |
| Sex: Female, Male Male | 4690 Participants | 5288 Participants | 9978 Participants |
| Study Clinic Oakland | 1528 participants | 1507 participants | 3035 participants |
| Study Clinic Sacramento | 986 participants | 1011 participants | 1997 participants |
| Study Clinic San Francisco | 2601 participants | 3188 participants | 5789 participants |
| Viral load <200 copies/mL | 4356 participants | 4754 participants | 9110 participants |
| Viral load >=200 copies/mL | 341 participants | 409 participants | 750 participants |
| Viral load No lab results in prior 365 days | 418 participants | 543 participants | 961 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5,706 | 0 / 5,115 |
| other Total, other adverse events | 0 / 5,706 | 0 / 5,115 |
| serious Total, serious adverse events | 0 / 5,706 | 0 / 5,115 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-implementation | Change in Mental Health and Substance Use Screening Rates | 2008 Participants |
| Post-implementation | Change in Mental Health and Substance Use Screening Rates | 2379 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pre-implementation | Treatment Rate | BHS only | 136 Participants |
| Pre-implementation | Treatment Rate | Specialty Care Only | 91 Participants |
| Pre-implementation | Treatment Rate | Medication Only | 261 Participants |
| Pre-implementation | Treatment Rate | Any treatment | 375 Participants |
| Post-implementation | Treatment Rate | Any treatment | 83 Participants |
| Post-implementation | Treatment Rate | Medication Only | 50 Participants |
| Post-implementation | Treatment Rate | Specialty Care Only | 24 Participants |
| Post-implementation | Treatment Rate | BHS only | 26 Participants |
| Post-implementation (Survey) | Treatment Rate | Specialty Care Only | 22 Participants |
| Post-implementation (Survey) | Treatment Rate | Any treatment | 194 Participants |
| Post-implementation (Survey) | Treatment Rate | Medication Only | 127 Participants |
| Post-implementation (Survey) | Treatment Rate | BHS only | 75 Participants |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-implementation | Treatment Rate | Any treatment | 1079 participants |
| Pre-implementation | Treatment Rate | Medication Only | 962 participants |
| Pre-implementation | Treatment Rate | BHS only | 221 participants |
| Pre-implementation | Treatment Rate | Specialty Care Only | 455 participants |
| Post-implementation | Treatment Rate | Specialty Care Only | 95 participants |
| Post-implementation | Treatment Rate | Any treatment | 249 participants |
| Post-implementation | Treatment Rate | BHS only | 44 participants |
| Post-implementation | Treatment Rate | Medication Only | 228 participants |
| Post-implementation (Survey) | Treatment Rate | Specialty Care Only | 90 participants |
| Post-implementation (Survey) | Treatment Rate | Medication Only | 191 participants |
| Post-implementation (Survey) | Treatment Rate | BHS only | 49 participants |
| Post-implementation (Survey) | Treatment Rate | Any treatment | 226 participants |
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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pre-implementation | Change in Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder 2-item (GAD-2) Scores | Depression (GAD-2) | -5.25 scores on a scale |
| Pre-implementation | Change in Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder 2-item (GAD-2) Scores | Anxiety (PHQ9) | -1.42 scores on a scale |
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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pre-implementation | Change in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS) | Tobacco | -0.36 scores on a scale |
| Pre-implementation | Change in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS) | Alcohol | -0.72 scores on a scale |
| Pre-implementation | Change in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS) | Cannabis | -0.61 scores on a scale |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-implementation | HIV Viral Control Change and Mental Health | 990 Participants |
| Post-implementation | HIV Viral Control Change and Mental Health | 240 Participants |
| Post-implementation (Survey) | HIV Viral Control Change and Mental Health | 253 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-implementation | HIV Viral Control Change and Substance Use | 867 Participants |
| Post-implementation | HIV Viral Control Change and Substance Use | 164 Participants |
| Post-implementation (Survey) | HIV Viral Control Change and Substance Use | 551 Participants |