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

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

    • 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
      • Los Angeles, California, United States, 90005
        • AIDS Project Los Angeles
      • San Francisco, California, United States, 94109
        • Shanti
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • AIDS Project Greater Danbury, Inc.
      • Hartford, Connecticut, United States, 06106
        • AIDS Connecticut, Inc
    • Delaware
      • Wilmington, Delaware, United States, 19801
        • Delaware HIV Consortium
    • District of Columbia
      • Washington, District of Columbia, United States, 20020
        • The Women's Collective
    • Florida
      • Melbourne, Florida, United States, 32901
        • Project Response, Inc.
    • Georgia
      • Athens, Georgia, United States, 30601
        • Live Forward (AIDS Athens)
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Champaign-Urbana Public Health District (Collaborating Organization)
    • Iowa
      • Davenport, Iowa, United States, 52808
        • The Project of the Quad Cities (Collaborating Organization)
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • AIDS Volunteers, Inc. (AVOL)
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Southwest Louisiana AIDS Council
    • Massachusetts
      • Worcester, Massachusetts, United States, 01604
        • AIDS Project Worcester
    • Michigan
      • Detroit, Michigan, United States, 48216
        • Health Emergency Lifeline Programs (Collaborating Organization)
      • Detroit, Michigan, United States, 48226
        • Community Health Awareness Group (Collaborating Organization)
      • Kalamazoo, Michigan, United States, 49008
        • Community AIDS Resources and Education Services (Collaborating Organization)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota AIDS Project (Collaborating Organization)
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Project ARK
      • Saint Louis, Missouri, United States, 63108
        • Doorways (Collaborating Organization)
      • Saint Louis, Missouri, United States, 63108
        • Places for People (Collaborating Organization)
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Effort for AIDS (Collaborating Organization)
      • Springfield, Missouri, United States, 65804
        • Burrell Behavioral Health (Collaborating Organization)
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska AIDS Project (Collaborating Organization )
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Southern NH HIV/AIDS Task Force
    • Ohio
      • Cincinnati, Ohio, United States, 45223
        • Caracole House (Collaborating Organization)
      • Columbus, Ohio, United States, 43214
        • ARC Ohio (Collaborating Organization)
    • Oregon
      • Eugene, Oregon, United States, 97403
        • HIV Alliance
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • AID Upstate
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Chattanooga CARES
      • Nashville, Tennessee, United States, 37204
        • Nashville CARES
    • Texas
      • Amarillo, Texas, United States, 79101
        • Panhandle AIDS Support Organization
      • Beaumont, Texas, United States, 77702
        • Triangle Area Network
      • Houston, Texas, United States, 77057
        • AIDS Foundation Houston
      • San Antonio, Texas, United States, 78207
        • Alamo Area Resource Center
    • Utah
      • Salt Lake City, Utah, United States, 84105
        • Utah AIDS Foundation
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Vermont CARES

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.
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.
4 weeks post randomization
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.
4 weeks post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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.

Clinical Trials on Substance Use

Clinical Trials on Motivational Interviewing

3
Subscribe