Trial Outcomes & Findings for Computerized Substance Use and Depression Screening and Behavioral Treatment in HIV Primary Care (NCT NCT03217058)

NCT ID: NCT03217058

Last Updated: 2025-10-07

Results Overview

Rate of screening using usual care methods (pre-implementation) compared with rate of screening using computerized methods, based on electronic health record (EHR) data.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10821 participants
• Primary outcome timeframe: 12 months pre-implementation period to the end of the implementation period, up to 21 months
• Results posted on: 2025-10-07

Participant Flow

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.

Participant milestones

Measure	Oakland Clinic HIV positive participants who received primary care at the Oakland clinic	Sacramento Clinic HIV positive participants who received primary care at the Sacramento clinic	San Francisco Clinic HIV positive participants who received primary care at the San Francisco clinic
Pre-Implementation STARTED	1507	1011	3188
Pre-Implementation COMPLETED	1507	1011	3188
Pre-Implementation NOT COMPLETED	0	0	0
Post-Implementation STARTED	1528	986	2601
Post-Implementation COMPLETED	1528	986	2601
Post-Implementation NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Pre-implementation n=5706 Participants 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 n=5115 Participants 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.	Total n=10821 Participants Total of all reporting groups
Age, Categorical <=18 years	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5034 Participants n=5 Participants	4335 Participants n=7 Participants	9369 Participants n=5 Participants
Age, Categorical >=65 years	666 Participants n=5 Participants	777 Participants n=7 Participants	1443 Participants n=5 Participants
Sex: Female, Male Female	418 Participants n=5 Participants	425 Participants n=7 Participants	843 Participants n=5 Participants
Sex: Female, Male Male	5288 Participants n=5 Participants	4690 Participants n=7 Participants	9978 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) Asian	374 Participants n=5 Participants	332 Participants n=7 Participants	706 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1022 Participants n=5 Participants	993 Participants n=7 Participants	2015 Participants n=5 Participants
Race (NIH/OMB) White	3123 Participants n=5 Participants	2680 Participants n=7 Participants	5803 Participants n=5 Participants
Race (NIH/OMB) More than one race	180 Participants n=5 Participants	157 Participants n=7 Participants	337 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	954 Participants n=5 Participants	902 Participants n=7 Participants	1856 Participants n=5 Participants
Region of Enrollment United States	5706 participants n=5 Participants	5115 participants n=7 Participants	10821 participants n=5 Participants
Study Clinic Oakland	1507 participants n=5 Participants	1528 participants n=7 Participants	3035 participants n=5 Participants
Study Clinic Sacramento	1011 participants n=5 Participants	986 participants n=7 Participants	1997 participants n=5 Participants
Study Clinic San Francisco	3188 participants n=5 Participants	2601 participants n=7 Participants	5789 participants n=5 Participants
HIV Transmission Risk factor MSM	4337 participants n=5 Participants	3834 participants n=7 Participants	8171 participants n=5 Participants
HIV Transmission Risk factor Heterosexual	600 participants n=5 Participants	601 participants n=7 Participants	1201 participants n=5 Participants
HIV Transmission Risk factor IDU	408 participants n=5 Participants	363 participants n=7 Participants	771 participants n=5 Participants
HIV Transmission Risk factor Other/Unknown	361 participants n=5 Participants	317 participants n=7 Participants	678 participants n=5 Participants
CD4 cells <200 T cells/ul	193 participants n=5 Participants	198 participants n=7 Participants	391 participants n=5 Participants
CD4 cells 200-350 T cells/ul	373 participants n=5 Participants	378 participants n=7 Participants	751 participants n=5 Participants
CD4 cells 350-500 T cells/ul	657 participants n=5 Participants	662 participants n=7 Participants	1319 participants n=5 Participants
CD4 cells >500 T cells/ul	3308 participants n=5 Participants	2900 participants n=7 Participants	6208 participants n=5 Participants
CD4 cells No lab results in prior 365 days	1175 participants n=5 Participants	977 participants n=7 Participants	2152 participants n=5 Participants
Viral load <200 copies/mL	4754 participants n=5 Participants	4356 participants n=7 Participants	9110 participants n=5 Participants
Viral load >=200 copies/mL	409 participants n=5 Participants	341 participants n=7 Participants	750 participants n=5 Participants
Viral load No lab results in prior 365 days	543 participants n=5 Participants	418 participants n=7 Participants	961 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Pre-implementation n=5706 Participants 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 n=5115 Participants 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.	Post-implementation (Survey) 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.
Change in Mental Health and Substance Use Screening Rates	2008 Participants	2379 Participants	—

PRIMARY outcome

Timeframe: Percent treated by 6 months after newly identified substance use

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

Outcome measures

Measure	Pre-implementation n=1135 Participants 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 n=238 Participants 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.	Post-implementation (Survey) n=746 Participants 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.
Treatment Rate Any treatment	375 Participants	83 Participants	194 Participants
Treatment Rate Medication Only	261 Participants	50 Participants	127 Participants
Treatment Rate BHS only	136 Participants	26 Participants	75 Participants
Treatment Rate Specialty Care Only	91 Participants	24 Participants	22 Participants

PRIMARY outcome

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

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

Outcome measures

Measure	Pre-implementation n=1300 Participants 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 n=341 Participants 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.	Post-implementation (Survey) n=347 Participants 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.
Treatment Rate Any treatment	1079 participants	249 participants	226 participants
Treatment Rate Medication Only	962 participants	228 participants	191 participants
Treatment Rate BHS only	221 participants	44 participants	49 participants
Treatment Rate Specialty Care Only	455 participants	95 participants	90 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Pre-implementation n=403 Participants 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. 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.	Post-implementation (Survey) 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.
Change in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS) Tobacco	-0.36 scores on a scale Interval -0.49 to -0.23	—	—
Change in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS) Alcohol	-0.72 scores on a scale Interval -0.87 to -0.58	—	—
Change in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS) Cannabis	-0.61 scores on a scale Interval -0.75 to -0.47	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Pre-implementation n=403 Participants 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. 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.	Post-implementation (Survey) 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.
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 Interval -1.75 to -1.09	—	—
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 Interval -6.44 to -4.06	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Pre-implementation n=974 Participants 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 n=189 Participants 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.	Post-implementation (Survey) n=580 Participants 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.
HIV Viral Control Change and Substance Use	867 Participants	164 Participants	551 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Pre-implementation n=1088 Participants 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 n=261 Participants 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.	Post-implementation (Survey) n=269 Participants 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.
HIV Viral Control Change and Mental Health	990 Participants	240 Participants	253 Participants

Adverse Events

Pre-implementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Post-implementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Derek Satre, Principal Investigator

University of California San Francisco

Phone: 415-476-7382

Email: Derek.Satre@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place