Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT07141394
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-10
First Post:
2025-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coordinated Access for Addiction Recovery and Equity in VA Supportive Housing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Investigators are implementing two evidence-based Substance Use Disorder (SUD) services - Medications for addiction treatment (MAT) and cognitive behavioral therapy for SUDs (CBT-SUD) - among Veterans in the Department of Housing and Urban Development-VA Supportive Housing Program (HUD-VASH).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7908}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2025-08-18', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reach of MAT (Medications for Addiction Treatment)', 'timeFrame': '18 months post-implementation', 'description': '* (percent of) Veterans who used Medications for Opioid Use Disorder (MOUD) for OUD, ≥1 prescription\n* (percent of) Veterans who used MOUD for OUD for 180 days since initial prescription (without a break ≥14 days in supply)\n* (percent of) Veterans who used Medications for Alcohol Use Disorder (MAUD) for AUD, ≥1 prescription\n* (percent of) Veterans who used MAUD for AUD for 180 days since initial prescription (without a break ≥14 days in supply)'}, {'measure': 'Reach of CBT-SUD (Cognitive Behavioral Therapy-Substance Use Disorders)', 'timeFrame': '18 months post-implementation', 'description': '* (percent of) Veterans with stimulant use disorder who had ≥1 visit for Cognitive Behavioral Therapy-Substance Use Disorders (CBT-SUD) or contingency management\n* (percent of) Veterans with substance use disorder with ≥1 CBT-SUD visit\n* (percent of) Veterans with substance use disorder with ≥9 CBT-SUD visits'}, {'measure': 'Adoption of MAT (Medications for Addiction Treatment)', 'timeFrame': '18 months post-implementation', 'description': '% (percent of) Department of Housing and Urban Development - VA Supportive Housing (HUD-VASH) and mental health prescribers engaged with Veterans who ordered Medications for Opioid Use Disorder (MOUD) / Medications for Alcohol Use Disorder (MAUD) at least once'}, {'measure': 'Adoption of CBT-SUD (Cognitive Behavioral Therapy-Substance Use Disorders)', 'timeFrame': '18 months post-implementation', 'description': '% (percent of) Department of Housing and Urban Development - VA Supportive Housing (HUD-VASH) case managers who delivered ≥1 CBT-SUD (Cognitive Behavioral Therapy-Substance Use Disorders) session'}, {'measure': 'Sustainment of MAT (Medications for Addiction Treatment)', 'timeFrame': '18-27 months post-implementation', 'description': '* (percent of) Veterans who used Medications for Opioid Use Disorder (MOUD) for OUD, ≥1 prescription\n* (percent of) Veterans who used MOUD for OUD for 180 days since initial prescription (without a break ≥14 days in supply)\n* (percent of) Veterans who used Medications for Alcohol Use Disorder (MAUD) for AUD, ≥1 prescription\n* (percent of) Veterans who used MAUD for AUD for 180 days since initial prescription (without a break ≥14 days in supply)\n* (percent of) Department of Housing and Urban Development - VA Supportive Housing (HUD-VASH) and mental health prescribers engaged with Veterans who ordered Medications for Opioid Use Disorder (MOUD) / Medications for Alcohol Use Disorder (MAUD) at least once'}, {'measure': 'Sustainment of CBT-SUD (Cognitive Behavioral Therapy-Substance Use Disorders)', 'timeFrame': '18-27 months post-implementation', 'description': '* (percent of) Veterans with stimulant use disorder who had ≥1 visit for Cognitive Behavioral Therapy-Substance Use Disorders (CBT-SUD) or contingency management\n* (percent of) Veterans with substance use disorder with ≥1 CBT-SUD visit\n* (percent of) Veterans with substance use disorder with ≥9 CBT-SUD visits\n* (percent of) Department of Housing and Urban Development - VA Supportive Housing (HUD-VASH) case managers who delivered ≥1 CBT-SUD (Cognitive Behavioral Therapy-Substance Use Disorders) session'}], 'secondaryOutcomes': [{'measure': 'Housing retention', 'timeFrame': '1 year after implementation by cohort', 'description': 'Difference in the mean days homeless over 1 year of follow-up for Veterans enrolled in trial sites that received the base versus enhanced implementation strategy, versus the expected number of days homeless had they enrolled in a comparison group of all sites not engaged in the trial'}, {'measure': 'Provider experience', 'timeFrame': 'Baseline and 18 months post-implementation', 'description': 'Experiences of and satisfaction with providing HUD-VASH services to HEVs with SUDs pre- and post- implementation, which will be assessed using semi-structured qualitative interviews (data will be coded from key findings in the narratives provided during the interviews).'}, {'measure': 'Cost impact of Medications for Addiction Treatment (MAT) and Cognitive Behavioral Therapy-Substance Use Disorders (CBT-SUD)', 'timeFrame': '18 months (during the course of implementation)', 'description': 'The predominant cost of delivering MAT in the Department of Housing and Urban Development-VA Supportive Housing (HUD-VASH) programs is prescriber time; for CBT-SUD, the predominant cost is case manager time. We will use VA administrative data to identify visits in which MAT was prescribed or CBT-SUD was delivered. Interviews with HUD-VASH prescribers will be used to estimate minutes/visit spent on MAT, including visits in which MAT was discussed but not prescribed; at implementation sites, we will add a mandated field to templated CBT-SUD notes that indicates time spent outside the encounter (e.g., preparing for the visit).'}, {'measure': 'Acute care utilization', 'timeFrame': '1 year after implementation by cohort', 'description': 'Emergency department visits and hospitalizations associated with primary SUD diagnoses'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Homeless', 'Substance Use Disorder', 'Permanent Supportive Housing', 'Implementation Science'], 'conditions': ['Homelessness', 'Substance Use Disorder (SUD)']}, 'descriptionModule': {'briefSummary': 'The Department of Housing and Urban Development-VA Supportive Housing (HUD-VASH) Program provides subsidized permanent housing with case management to homeless-experienced Veterans (HEVs). Up to 40% of Veterans exit HUD-VASH within two years of attaining housing; substance use disorders (SUDs) are one of the largest causes of returns to homelessness for HEVs. CARE-VASH QUERI proposes to implement and evaluate two evidence-based SUD services - Medications for addiction treatment (MAT) and cognitive behavioral therapy for SUDs (CBT-SUD) - among Veterans in HUD-VASH.', 'detailedDescription': 'The Department of Housing and Urban Development-VA Supportive Housing (HUD-VASH) program provides subsidized, permanent housing and supports to Veterans experiencing homelessness. Substance use disorders (SUDs) are a common primary or contributing factor to negative exits from HUD-VASH. The Coordinated Access for Addiction Recovery and Equity in VA Supportive Housing (CARE-VASH) QUERI will implement two evidence-based practices (EBPs) for SUDs-Medications for Addiction Treatment (MAT) and cognitive behavioral therapy for SUDs (CBT-SUD)-in 12 HUD-VASH sites. We will use the Replicating Effective Programs (REP) implementation bundle to support EBP implementation at all 12 sites. Half the sites (n=6) will also receive 9 months of consumer engagement (REP+CE). In a type 3 hybrid trial, we will use mixed methods to examine the impacts of REP vs. REP+CE. Using our trial data, we will develop a budget impact analysis and implementation playbook for our program partners to spread and sustain MAT and CBT-SUD in HUD-VASH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Homeless-experienced Veterans (HEVs) enrolled in the Department of Housing and Urban Development-VA Supportive Housing (HUD-VASH) Program.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT07141394', 'acronym': 'CARE-VASH', 'briefTitle': 'Coordinated Access for Addiction Recovery and Equity in VA Supportive Housing', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Coordinated Access for Addiction Recovery and Equity in VA Supportive Housing (CARE-VASH) (QUE 25-013)', 'orgStudyIdInfo': {'id': 'QUX 25-001'}, 'secondaryIdInfos': [{'id': 'QUE 25-013', 'type': 'OTHER_GRANT', 'domain': 'QUERI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Replicating Effective Programs (REP)', 'description': 'A stakeholder-informed training and technical assistance implementation strategy', 'interventionNames': ['Drug: Medication for Addiction Treatment (MAT)', 'Behavioral: Cognitive Behavioral Therapy for Substance Use Disorders (CBT-SUD)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'REP + Consumer Engagement (CE)', 'description': 'REP plus CE package (educational materials, peer coaching, toolkit) to support MAT and CBT-SUD implementation.', 'interventionNames': ['Drug: Medication for Addiction Treatment (MAT)', 'Behavioral: Cognitive Behavioral Therapy for Substance Use Disorders (CBT-SUD)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No MAT or CBT-SUD implementation'}], 'interventions': [{'name': 'Medication for Addiction Treatment (MAT)', 'type': 'DRUG', 'otherNames': ['MAT'], 'description': 'MAT includes medications for alcohol use disorder (MAUD) and medications for opioid use disorder (MAUD). It reduces substance use, increases SUD treatment engagement, enhances quality of life, and reduces overdoses.', 'armGroupLabels': ['REP + Consumer Engagement (CE)', 'Replicating Effective Programs (REP)']}, {'name': 'Cognitive Behavioral Therapy for Substance Use Disorders (CBT-SUD)', 'type': 'BEHAVIORAL', 'otherNames': ['CBT-SUD'], 'description': 'An evidence-based psychotherapy that uses cognitive behavioral therapy to further recovery goals across SUD diagnoses.', 'armGroupLabels': ['REP + Consumer Engagement (CE)', 'Replicating Effective Programs (REP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90073-1003', 'city': 'West Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare System, West Los Angeles, CA', 'geoPoint': {'lat': 34.0462, 'lon': -118.43068}}], 'centralContacts': [{'name': 'Sonya E Gabrielian, MD MPH', 'role': 'CONTACT', 'email': 'Sonya.Gabrielian@va.gov', 'phone': '(310) 478-3711', 'phoneExt': '49853'}, {'name': 'Jenny M Barnard, BA', 'role': 'CONTACT', 'email': 'Jenny.Barnard@va.gov', 'phone': '(626) 367-1077'}], 'overallOfficials': [{'name': 'Sonya Emi Gabrielian, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Greater Los Angeles Healthcare System, West Los Angeles, CA'}, {'name': 'Evelyn T Chang, MD MSHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Greater Los Angeles Healthcare System, Sepulveda, CA'}, {'name': 'Erin P Finley, PhD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Greater Los Angeles Healthcare System, West Los Angeles, CA'}, {'name': 'Emily Treichler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA San Diego Healthcare System, San Diego, CA'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'University of California, Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}