- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02495402
Substance Abuse Treatment to HIV Care (SAT2HIV): The Motivational Interviewing-based Brief Intervention Experiment
May 7, 2018 updated by: RTI International
Substance Abuse Treatment to HIV Care (SAT2HIV): The Motivational Interviewing-based Brief Intervention (MIBI) Experiment
To test the effectiveness of a single 20-30 minute motivational interviewing-based brief intervention for substance use within HIV/AIDS settings.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Interventional
Enrollment (Actual)
827
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
-
Phoenix, Arizona, United States, 85014
- HIV Care Directions
-
-
California
-
Claremont, California, United States, 91711
- Foothill AIDS Project
-
Irvine, California, United States, 92614
- AIDS Services Foundation, Orange County
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Los Angeles, California, United States, 90005
- AIDS Project Los Angeles
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San Francisco, California, United States, 94109
- Shanti
-
-
Connecticut
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Danbury, Connecticut, United States, 06810
- AIDS Project Greater Danbury, Inc.
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Hartford, Connecticut, United States, 06106
- AIDS Connecticut, Inc
-
-
Delaware
-
Wilmington, Delaware, United States, 19801
- Delaware HIV Consortium
-
-
District of Columbia
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Washington, District of Columbia, United States, 20020
- The Women's Collective
-
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Florida
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Melbourne, Florida, United States, 32901
- Project Response, Inc.
-
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Georgia
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Athens, Georgia, United States, 30601
- Live Forward (AIDS Athens)
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Illinois
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Champaign, Illinois, United States, 61820
- Champaign-Urbana Public Health District (Collaborating Organization)
-
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Iowa
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Davenport, Iowa, United States, 52808
- The Project of the Quad Cities (Collaborating Organization)
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Kentucky
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Lexington, Kentucky, United States, 40504
- AIDS Volunteers, Inc. (AVOL)
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Louisiana
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Lake Charles, Louisiana, United States, 70601
- Southwest Louisiana AIDS Council
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Massachusetts
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Worcester, Massachusetts, United States, 01604
- AIDS Project Worcester
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Michigan
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Detroit, Michigan, United States, 48216
- Health Emergency Lifeline Programs (Collaborating Organization)
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Detroit, Michigan, United States, 48226
- Community Health Awareness Group (Collaborating Organization)
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Kalamazoo, Michigan, United States, 49008
- Community AIDS Resources and Education Services (Collaborating Organization)
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Minnesota AIDS Project (Collaborating Organization)
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Missouri
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Saint Louis, Missouri, United States, 63110
- Project ARK
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Saint Louis, Missouri, United States, 63108
- Doorways (Collaborating Organization)
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Saint Louis, Missouri, United States, 63108
- Places for People (Collaborating Organization)
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Saint Louis, Missouri, United States, 63110
- St. Louis Effort for AIDS (Collaborating Organization)
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Springfield, Missouri, United States, 65804
- Burrell Behavioral Health (Collaborating Organization)
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Nebraska
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Omaha, Nebraska, United States, 68114
- Nebraska AIDS Project (Collaborating Organization )
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New Hampshire
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Nashua, New Hampshire, United States, 03060
- Southern NH HIV/AIDS Task Force
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Ohio
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Cincinnati, Ohio, United States, 45223
- Caracole House (Collaborating Organization)
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Columbus, Ohio, United States, 43214
- ARC Ohio (Collaborating Organization)
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Oregon
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Eugene, Oregon, United States, 97403
- HIV Alliance
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South Carolina
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Greenville, South Carolina, United States, 29601
- AID Upstate
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Tennessee
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Chattanooga, Tennessee, United States, 37403
- Chattanooga CARES
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Nashville, Tennessee, United States, 37204
- Nashville CARES
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Texas
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Amarillo, Texas, United States, 79101
- Panhandle AIDS Support Organization
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Beaumont, Texas, United States, 77702
- Triangle Area Network
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Houston, Texas, United States, 77057
- AIDS Foundation Houston
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San Antonio, Texas, United States, 78207
- Alamo Area Resource Center
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Utah
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Salt Lake City, Utah, United States, 84105
- Utah AIDS Foundation
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Vermont
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Burlington, Vermont, United States, 05401
- Vermont CARES
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have HIV/AIDS.
- Be 18 years of age or older.
- Acknowledges use of at least one substance within the past 28 days and endorse 2+ substance use disorder symptoms during the past 12-months.
- Provide signed and dated assurance of consent.
Exclusion Criteria:
- Are unable to speak English.
- Are unwilling to allow brief intervention sessions to be audio recorded.
- Are unwilling to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: No Intervention: Control
No Intervention
|
|
EXPERIMENTAL: Motivational Interviewing
A brief interview intervention for substance abuse
|
Participants assigned to the experimental condition receive a single 20-30 minute motivational interviewing-based brief intervention for substance use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days of Primary Substance Use
Time Frame: 4 weeks post randomization
|
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.
|
4 weeks post randomization
|
Number of Substance-related problems
Time Frame: 4 weeks post randomization
|
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.
|
4 weeks post randomization
|
Times engaging in risky behaviors
Time Frame: 4 weeks post randomization
|
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.
|
4 weeks post randomization
|
Days of Substance Use Treatment
Time Frame: 4 weeks post randomization
|
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.
|
4 weeks post randomization
|
ART Medication Adherence
Time Frame: 4 weeks post randomization
|
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.
|
4 weeks post randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urgency to Change
Time Frame: 4 weeks post randomization
|
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.
|
4 weeks post randomization
|
Intentions to Change
Time Frame: 4 weeks post randomization
|
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.
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4 weeks post randomization
|
Commitment to Change
Time Frame: 4 weeks post randomization
|
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.
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4 weeks post randomization
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Self-Efficacy to Change
Time Frame: 4 weeks post randomization
|
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.
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4 weeks post randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bryan R Garner, PhD, RTI International
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. Erratum In: Addict Sci Clin Pract. 2018 Feb 21;13(1):9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 8, 2015
Primary Completion (ACTUAL)
December 28, 2017
Study Completion (ACTUAL)
March 25, 2018
Study Registration Dates
First Submitted
July 6, 2015
First Submitted That Met QC Criteria
July 8, 2015
First Posted (ESTIMATE)
July 13, 2015
Study Record Updates
Last Update Posted (ACTUAL)
May 9, 2018
Last Update Submitted That Met QC Criteria
May 7, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAT2HIV
- R01DA038146 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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