Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-03-02 @ 4:06 AM
Study NCT ID:
NCT02495402
Status:
COMPLETED
Last Update Posted:
2018-05-09
First Post:
2015-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Substance Abuse Treatment to HIV Care (SAT2HIV): The Motivational Interviewing-based Brief Intervention Experiment
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': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 827}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-07', 'studyFirstSubmitDate': '2015-07-06', 'studyFirstSubmitQcDate': '2015-07-08', 'lastUpdatePostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days of Primary Substance Use', 'timeFrame': '4 weeks post randomization', 'description': 'Days of Primary Substance Use - A continuous measure (ranges from 0 - 28) that is based on a question that asks participants to report how many days during the past 28 days they used their primary substance.'}, {'measure': 'Number of Substance-related problems', 'timeFrame': '4 weeks post randomization', 'description': 'Number of Substance-related problems - A continuous measure (ranges from 0 - 11) that represents the sum of the number of 11 DSM-V substance use disorder symptoms participants report having occured during the past 28 days.'}, {'measure': 'Times engaging in risky behaviors', 'timeFrame': '4 weeks post randomization', 'description': 'Times engaging in risky behaviors - A continuous measure (no specified range) that is based on a question that asks participants to report how many times during the past 28 days they engaged in unprotected sex, IV drug use, or needle sharing.'}, {'measure': 'Days of Substance Use Treatment', 'timeFrame': '4 weeks post randomization', 'description': 'Days of Substance Use Treatment - A continuous measure (no specified range) that represents the sum of the number of days participants report going to residential treatment, outpatient treatment, or self-help group meetings during the past 28 days.'}, {'measure': 'ART Medication Adherence', 'timeFrame': '4 weeks post randomization', 'description': 'ART Medication Adherence - A continuous measure (ranges from 0 -28) that is based on a question that asks participants to report how many days during the past 28 days that they have missed at least one dose of their HIV medications.'}], 'secondaryOutcomes': [{'measure': 'Urgency to Change', 'timeFrame': '4 weeks post randomization', 'description': 'Urgency to Change - A continuous measure (ranges from 0 - 20) that represents the sum of two questions that ask participants to use a Likert-type scale where 0 equals "Not at all" and 10 equals "The highest level possible" to indicate their urgency during the past 4 weeks to a) reduce their use of their primary substance and b) completely stop using their primary substance.'}, {'measure': 'Intentions to Change', 'timeFrame': '4 weeks post randomization', 'description': 'Intentions to Change - A continuous measure (ranges from 0 - 20) that represents the sum of two questions that ask participants to use a Likert-type scale where 0 equals "Not at all" and 10 equals "The highest level possible" to indicate their intentions during the past 4 weeks to a) reduce their use of their primary substance and b) completely stop using their primary substance.'}, {'measure': 'Commitment to Change', 'timeFrame': '4 weeks post randomization', 'description': 'Commitment to Change - A continuous measure (ranges from 0 - 20) that represents the sum of two questions that ask participants to use a Likert-type scale where 0 equals "Not at all" and 10 equals "The highest level possible" to indicate their commitment during the past 4 weeks to a) reduce their use of their primary substance and b) completely stop using their primary substance.'}, {'measure': 'Self-Efficacy to Change', 'timeFrame': '4 weeks post randomization', 'description': 'Self Efficacy for Change - A continuous measure (ranges from 0 - 20) that represents the sum of two questions that ask participants to use a Likert-type scale where 0 equals "Not at all" and 10 equals "The highest level possible" to indicate their confidence during the past 4 weeks to a) reduce their use of their primary substance and b) completely stop using their primary substance.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Substance Use']}, 'referencesModule': {'references': [{'pmid': '34930497', 'type': 'DERIVED', 'citation': 'Ford JH 2nd, Gilson AM, Maurer MA, Hoffman KA, Garner BR. A peek behind the curtain: exploring coaching styles within the implementation and sustainment facilitation (ISF) strategy in the substance abuse treatment to HIV care study. Implement Sci Commun. 2021 Dec 20;2(1):140. doi: 10.1186/s43058-021-00246-2.'}, {'pmid': '29149914', 'type': 'DERIVED', 'citation': 'Garner BR, Gotham HJ, Tueller SJ, Ball EL, Kaiser D, Stilen P, Speck K, Vandersloot D, Rieckmann TR, Chaple M, Martin EG, Martino S. Testing the effectiveness of a motivational interviewing-based brief intervention for substance use as an adjunct to usual care in community-based AIDS service organizations: study protocol for a multisite randomized controlled trial. Addict Sci Clin Pract. 2017 Nov 17;12(1):31. doi: 10.1186/s13722-017-0095-8.'}]}, 'descriptionModule': {'briefSummary': 'To test the effectiveness of a single 20-30 minute motivational interviewing-based brief intervention for substance use within HIV/AIDS settings.', 'detailedDescription': 'The Substance Abuse Treatment to HIV care (SAT2HIV) project, a Type 2 Effectiveness-Implementation Hybrid Trial, seeks to address this gap in services by providing new knowledge regarding the effectiveness of brief intervention (BI) for substance use within community-based HIV/AIDS service settings, as well as new knowledge regarding how to address the well-documented underutilization of evidence-based practices in real-world settings. The specific aims of this project are: Aim 1: To experimentally test the effectiveness of a motivational interviewing-based BI for substance use within community-based HIV/AIDS service organizations, relative to usual care (UC). Aim 2: To experimentally test the effectiveness of adding an organizational-level implementation intervention called Implementation \\& Sustainment Facilitation (ISF) to enhance the effectiveness of the implementation strategy currently used by SAMHSA-funded Addiction Technology Treatment Centers (ATTCs; i.e., online introductory training, 2-day training workshop, ongoing feedback and coaching).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have HIV/AIDS.\n* Be 18 years of age or older.\n* Acknowledges use of at least one substance within the past 28 days and endorse 2+ substance use disorder symptoms during the past 12-months.\n* Provide signed and dated assurance of consent.\n\nExclusion Criteria:\n\n* Are unable to speak English.\n* Are unwilling to allow brief intervention sessions to be audio recorded.\n* Are unwilling to participate in the study.'}, 'identificationModule': {'nctId': 'NCT02495402', 'briefTitle': 'Substance Abuse Treatment to HIV Care (SAT2HIV): The Motivational Interviewing-based Brief Intervention Experiment', 'organization': {'class': 'OTHER', 'fullName': 'RTI International'}, 'officialTitle': 'Substance Abuse Treatment to HIV Care (SAT2HIV): The Motivational Interviewing-based Brief Intervention (MIBI) Experiment', 'orgStudyIdInfo': {'id': 'SAT2HIV'}, 'secondaryIdInfos': [{'id': 'R01DA038146', 'link': 'https://reporter.nih.gov/quickSearch/R01DA038146', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Intervention: Control', 'description': 'No Intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Motivational Interviewing', 'description': 'A brief interview intervention for substance abuse', 'interventionNames': ['Behavioral: Motivational Interviewing']}], 'interventions': [{'name': 'Motivational Interviewing', 'type': 'BEHAVIORAL', 'description': 'Participants assigned to the experimental condition receive a single 20-30 minute motivational interviewing-based brief intervention for substance use.', 'armGroupLabels': ['Motivational Interviewing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'HIV Care Directions', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91711', 'city': 'Claremont', 'state': 'California', 'country': 'United States', 'facility': 'Foothill AIDS Project', 'geoPoint': {'lat': 34.09668, 'lon': -117.71978}}, {'zip': '92614', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'AIDS Services Foundation, Orange County', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90005', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'AIDS Project Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Shanti', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'AIDS Project Greater Danbury, Inc.', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'AIDS Connecticut, Inc', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '19801', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Delaware HIV Consortium', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20020', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "The Women's Collective", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32901', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Project Response, Inc.', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '30601', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Live Forward (AIDS Athens)', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '61820', 'city': 'Champaign', 'state': 'Illinois', 'country': 'United States', 'facility': 'Champaign-Urbana Public Health District (Collaborating Organization)', 'geoPoint': {'lat': 40.11642, 'lon': -88.24338}}, {'zip': '52808', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'The Project of the Quad Cities (Collaborating Organization)', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '40504', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'AIDS Volunteers, Inc. (AVOL)', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70601', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Southwest Louisiana AIDS Council', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '01604', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'AIDS Project Worcester', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48216', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Health Emergency Lifeline Programs (Collaborating Organization)', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48226', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Community Health Awareness Group (Collaborating Organization)', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49008', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Community AIDS Resources and Education Services 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'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'zip': '77057', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'AIDS Foundation Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78207', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Alamo Area Resource Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84105', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah AIDS Foundation', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Vermont CARES', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Bryan R Garner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RTI International'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RTI International', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}