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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
827

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: No Intervention: Control
No Intervention
EXPERIMENTAL: Motivational Interviewing
A brief interview intervention for substance abuse
Behavioral: Motivational Interviewing
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RTI International

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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