Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-22 @ 5:32 AM
Study NCT ID:
NCT03217058
Status:
COMPLETED
Last Update Posted:
2025-10-07
First Post:
2017-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Computerized Substance Use and Depression Screening and Behavioral Treatment in HIV Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Derek.Satre@ucsf.edu', 'phone': '415-476-7382', 'title': 'Dr. Derek Satre, Principal Investigator', 'organization': 'University of California San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 3 years and 9 months (Up to 2 years pre-implementation + up to 21 months post-implementation)', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-implementation', 'description': '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.', 'otherNumAtRisk': 5706, 'deathsNumAtRisk': 5706, 'otherNumAffected': 0, 'seriousNumAtRisk': 5706, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Post-implementation', 'description': '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.\n\nClinic-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.', 'otherNumAtRisk': 5115, 'deathsNumAtRisk': 5115, 'otherNumAffected': 0, 'seriousNumAtRisk': 5115, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mental Health and Substance Use Screening Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5706', 'groupId': 'OG000'}, {'value': '5115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-implementation', 'description': '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.'}, {'id': 'OG001', 'title': 'Post-implementation', 'description': '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.\n\nClinic-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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2008', 'groupId': 'OG000'}, {'value': '2379', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months pre-implementation period to the end of the implementation period, up to 21 months', 'description': 'Rate of screening using usual care methods (pre-implementation) compared with rate of screening using computerized methods, based on electronic health record (EHR) data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Treatment Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1135', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '746', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-implementation', 'description': '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.'}, {'id': 'OG001', 'title': 'Post-implementation (Clinical)', 'description': '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.\n\nClinic-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.'}, {'id': 'OG002', 'title': 'Post-implementation (Survey)', 'description': '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.\n\nClinic-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.'}], 'classes': [{'title': 'Any treatment', 'categories': [{'measurements': [{'value': '375', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}]}, {'title': 'Medication Only', 'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}]}, {'title': 'BHS only', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}]}, {'title': 'Specialty Care Only', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Percent treated by 6 months after newly identified substance use', 'description': 'Initiation of substance use, anxiety and depression treatment services, based on EHR data', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Treatment Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1300', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '347', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-implementation', 'description': '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.'}, {'id': 'OG001', 'title': 'Post-implementation (Clinical)', 'description': '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.\n\nClinic-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.'}, {'id': 'OG002', 'title': 'Post-implementation (Survey)', 'description': '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.\n\nClinic-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.'}], 'classes': [{'title': 'Any treatment', 'categories': [{'measurements': [{'value': '1079', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}]}]}, {'title': 'Medication Only', 'categories': [{'measurements': [{'value': '962', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}]}, {'title': 'BHS only', 'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Specialty Care Only', 'categories': [{'measurements': [{'value': '455', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Percent treated by 6 months after newly identified mental health problem', 'description': 'Initiation of substance use, anxiety and depression treatment services, based on EHR data', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Change in Post-intervention Positive Substance Use Screens', 'description': 'Change in post-intervention positive substance use screens between first post-intervention substance use screen and second post-intervention substance use screen'}], 'classes': [{'title': 'Tobacco', 'categories': [{'measurements': [{'value': '-0.36', 'groupId': 'OG000', 'lowerLimit': '-0.49', 'upperLimit': '-0.23'}]}]}, {'title': 'Alcohol', 'categories': [{'measurements': [{'value': '-0.72', 'groupId': 'OG000', 'lowerLimit': '-0.87', 'upperLimit': '-0.58'}]}]}, {'title': 'Cannabis', 'categories': [{'measurements': [{'value': '-0.61', 'groupId': 'OG000', 'lowerLimit': '-0.75', 'upperLimit': '-0.47'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First post intervention screen (1 month) to second post intervention screen (21 months)', 'description': '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.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change in Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder 2-item (GAD-2) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Change in Post-intervention Positive Depression and Anxiety Screens', 'description': 'Change in post-intervention positive depression and anxiety screens between first post-intervention depression or anxiety screen and second post-intervention depression or anxiety screen'}], 'classes': [{'title': 'Depression (GAD-2)', 'categories': [{'measurements': [{'value': '-5.25', 'groupId': 'OG000', 'lowerLimit': '-6.44', 'upperLimit': '-4.06'}]}]}, {'title': 'Anxiety (PHQ9)', 'categories': [{'measurements': [{'value': '-1.42', 'groupId': 'OG000', 'lowerLimit': '-1.75', 'upperLimit': '-1.09'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First post intervention screen (1 month) to second post intervention screen (21 months)', 'description': 'Unadjusted mean change of screening scores for depression and anxiety from first post intervention screen to second post intervention screen.\n\nThe PHQ-9 assesses degree of depression severity. The score ranges from zero - 27 with higher scores indicate higher depression.\n\nGAD-2 assesses degree of anxiety severity. The score ranges from zero - 6 with higher scores indicate higher anxiety.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'HIV Viral Control Change and Substance Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '974', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '580', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-implementation', 'description': '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.'}, {'id': 'OG001', 'title': 'Post-implementation (Clinical)', 'description': '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.\n\nClinic-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.'}, {'id': 'OG002', 'title': 'Post-implementation (Survey)', 'description': '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.\n\nClinic-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.'}], 'classes': [{'categories': [{'measurements': [{'value': '867', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '551', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'change between 24 months prior to clinic-specific implementation date and end of implementation period, up to 21 months', 'description': 'Change in participants with well controlled HIV RNA by 12 months after newly identified substance use problem', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'HIV Viral Control Change and Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1088', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '269', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-implementation', 'description': '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.'}, {'id': 'OG001', 'title': 'Post-implementation (Clinical)', 'description': '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.\n\nClinic-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.'}, {'id': 'OG002', 'title': 'Post-implementation (Survey)', 'description': '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.\n\nClinic-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.'}], 'classes': [{'categories': [{'measurements': [{'value': '990', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '253', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'change between 24 months prior to clinic-specific implementation date and end of implementation period, up to 21 months', 'description': 'Change in participants with well controlled HIV RNA by 12 months after newly identified mental health problem', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oakland Clinic', 'description': 'HIV positive participants who received primary care at the Oakland clinic'}, {'id': 'FG001', 'title': 'Sacramento Clinic', 'description': 'HIV positive participants who received primary care at the Sacramento clinic'}, {'id': 'FG002', 'title': 'San Francisco Clinic', 'description': 'HIV positive participants who received primary care at the San Francisco clinic'}], 'periods': [{'title': 'Pre-Implementation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1507'}, {'groupId': 'FG001', 'numSubjects': '1011'}, {'groupId': 'FG002', 'numSubjects': '3188'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1507'}, {'groupId': 'FG001', 'numSubjects': '1011'}, {'groupId': 'FG002', 'numSubjects': '3188'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Post-Implementation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1528'}, {'groupId': 'FG001', 'numSubjects': '986'}, {'groupId': 'FG002', 'numSubjects': '2601'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1528'}, {'groupId': 'FG001', 'numSubjects': '986'}, {'groupId': 'FG002', 'numSubjects': '2601'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5706', 'groupId': 'BG000'}, {'value': '5115', 'groupId': 'BG001'}, {'value': '10821', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pre-implementation', 'description': '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.'}, {'id': 'BG001', 'title': 'Post-implementation', 'description': '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.\n\nClinic-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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5034', 'groupId': 'BG000'}, {'value': '4335', 'groupId': 'BG001'}, {'value': '9369', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '666', 'groupId': 'BG000'}, {'value': '777', 'groupId': 'BG001'}, {'value': '1443', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '418', 'groupId': 'BG000'}, {'value': '425', 'groupId': 'BG001'}, {'value': '843', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5288', 'groupId': 'BG000'}, {'value': '4690', 'groupId': 'BG001'}, {'value': '9978', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '374', 'groupId': 'BG000'}, {'value': '332', 'groupId': 'BG001'}, {'value': '706', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1022', 'groupId': 'BG000'}, {'value': '993', 'groupId': 'BG001'}, {'value': '2015', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3123', 'groupId': 'BG000'}, {'value': '2680', 'groupId': 'BG001'}, {'value': '5803', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '954', 'groupId': 'BG000'}, {'value': '902', 'groupId': 'BG001'}, {'value': '1856', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5706', 'groupId': 'BG000'}, {'value': '5115', 'groupId': 'BG001'}, {'value': '10821', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Study Clinic', 'classes': [{'title': 'Oakland', 'categories': [{'measurements': [{'value': '1507', 'groupId': 'BG000'}, {'value': '1528', 'groupId': 'BG001'}, {'value': '3035', 'groupId': 'BG002'}]}]}, {'title': 'Sacramento', 'categories': [{'measurements': [{'value': '1011', 'groupId': 'BG000'}, {'value': '986', 'groupId': 'BG001'}, {'value': '1997', 'groupId': 'BG002'}]}]}, {'title': 'San Francisco', 'categories': [{'measurements': [{'value': '3188', 'groupId': 'BG000'}, {'value': '2601', 'groupId': 'BG001'}, {'value': '5789', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HIV Transmission Risk factor', 'classes': [{'title': 'MSM', 'categories': [{'measurements': [{'value': '4337', 'groupId': 'BG000'}, {'value': '3834', 'groupId': 'BG001'}, {'value': '8171', 'groupId': 'BG002'}]}]}, {'title': 'Heterosexual', 'categories': [{'measurements': [{'value': '600', 'groupId': 'BG000'}, {'value': '601', 'groupId': 'BG001'}, {'value': '1201', 'groupId': 'BG002'}]}]}, {'title': 'IDU', 'categories': [{'measurements': [{'value': '408', 'groupId': 'BG000'}, {'value': '363', 'groupId': 'BG001'}, {'value': '771', 'groupId': 'BG002'}]}]}, {'title': 'Other/Unknown', 'categories': [{'measurements': [{'value': '361', 'groupId': 'BG000'}, {'value': '317', 'groupId': 'BG001'}, {'value': '678', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'CD4 cells', 'classes': [{'title': '<200 T cells/ul', 'categories': [{'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}]}]}, {'title': '200-350 T cells/ul', 'categories': [{'measurements': [{'value': '373', 'groupId': 'BG000'}, {'value': '378', 'groupId': 'BG001'}, {'value': '751', 'groupId': 'BG002'}]}]}, {'title': '350-500 T cells/ul', 'categories': [{'measurements': [{'value': '657', 'groupId': 'BG000'}, {'value': '662', 'groupId': 'BG001'}, {'value': '1319', 'groupId': 'BG002'}]}]}, {'title': '>500 T cells/ul', 'categories': [{'measurements': [{'value': '3308', 'groupId': 'BG000'}, {'value': '2900', 'groupId': 'BG001'}, {'value': '6208', 'groupId': 'BG002'}]}]}, {'title': 'No lab results in prior 365 days', 'categories': [{'measurements': [{'value': '1175', 'groupId': 'BG000'}, {'value': '977', 'groupId': 'BG001'}, {'value': '2152', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Viral load', 'classes': [{'title': '<200 copies/mL', 'categories': [{'measurements': [{'value': '4754', 'groupId': 'BG000'}, {'value': '4356', 'groupId': 'BG001'}, {'value': '9110', 'groupId': 'BG002'}]}]}, {'title': '>=200 copies/mL', 'categories': [{'measurements': [{'value': '409', 'groupId': 'BG000'}, {'value': '341', 'groupId': 'BG001'}, {'value': '750', 'groupId': 'BG002'}]}]}, {'title': 'No lab results in prior 365 days', 'categories': [{'measurements': [{'value': '543', 'groupId': 'BG000'}, {'value': '418', 'groupId': 'BG001'}, {'value': '961', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2022-10-05', 'size': 416829, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-12T17:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Stepped-wedge design evaluating implementation of computerized screening and behavioral interventions delivered by primary care providers.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10821}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2017-07-07', 'resultsFirstSubmitDate': '2025-04-04', 'studyFirstSubmitQcDate': '2017-07-12', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-18', 'studyFirstPostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mental Health and Substance Use Screening Rates', 'timeFrame': '12 months pre-implementation period to the end of the implementation period, up to 21 months', 'description': 'Rate of screening using usual care methods (pre-implementation) compared with rate of screening using computerized methods, based on electronic health record (EHR) data.'}, {'measure': 'Treatment Rate', 'timeFrame': 'Percent treated by 6 months after newly identified substance use', 'description': 'Initiation of substance use, anxiety and depression treatment services, based on EHR data'}, {'measure': 'Treatment Rate', 'timeFrame': 'Percent treated by 6 months after newly identified mental health problem', 'description': 'Initiation of substance use, anxiety and depression treatment services, based on EHR data'}], 'secondaryOutcomes': [{'measure': 'Change in Substance Use Severity: Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS)', 'timeFrame': 'First post intervention screen (1 month) to second post intervention screen (21 months)', 'description': '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.'}, {'measure': 'Change in Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder 2-item (GAD-2) Scores', 'timeFrame': 'First post intervention screen (1 month) to second post intervention screen (21 months)', 'description': 'Unadjusted mean change of screening scores for depression and anxiety from first post intervention screen to second post intervention screen.\n\nThe PHQ-9 assesses degree of depression severity. The score ranges from zero - 27 with higher scores indicate higher depression.\n\nGAD-2 assesses degree of anxiety severity. The score ranges from zero - 6 with higher scores indicate higher anxiety.'}, {'measure': 'HIV Viral Control Change and Substance Use', 'timeFrame': 'change between 24 months prior to clinic-specific implementation date and end of implementation period, up to 21 months', 'description': 'Change in participants with well controlled HIV RNA by 12 months after newly identified substance use problem'}, {'measure': 'HIV Viral Control Change and Mental Health', 'timeFrame': 'change between 24 months prior to clinic-specific implementation date and end of implementation period, up to 21 months', 'description': 'Change in participants with well controlled HIV RNA by 12 months after newly identified mental health problem'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['digital health', 'implementation', 'primary care'], 'conditions': ['Substance Use Disorders', 'HIV', 'Depression', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '37194051', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '35139911', 'type': 'DERIVED', 'citation': 'Lea 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.'}, {'pmid': '31446142', 'type': 'DERIVED', 'citation': 'Satre 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-positive adults\n\nExclusion Criteria:\n\n* Patients under age 18'}, 'identificationModule': {'nctId': 'NCT03217058', 'acronym': 'PACE', 'briefTitle': 'Computerized Substance Use and Depression Screening and Behavioral Treatment in HIV Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Implementing Computerized Substance Use and Depression Screening and Evidence-based Treatments in an HIV Primary Care Population', 'orgStudyIdInfo': {'id': '16-20272'}, 'secondaryIdInfos': [{'id': 'K24AA025703', 'link': 'https://reporter.nih.gov/quickSearch/K24AA025703', 'type': 'NIH'}, {'id': 'R01DA043139', 'link': 'https://reporter.nih.gov/quickSearch/R01DA043139', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Pre-implementation', 'description': '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.'}, {'type': 'EXPERIMENTAL', 'label': 'Post-implementation', 'description': '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.', 'interventionNames': ['Behavioral: Clinic-based screening and behavioral interventions']}], 'interventions': [{'name': 'Clinic-based screening and behavioral interventions', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Post-implementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Division of Research', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'overallOfficials': [{'name': 'Derek Satre, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kaiser Foundation Research Institute', 'class': 'OTHER'}, {'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}