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Substance UseNCT02495402

Substance Abuse Treatment to HIV Care (SAT2HIV): The Motivational Interviewing-based Brief Intervention Experiment

A study testing Motivational Interviewing in people with Substance Use, run by RTI International at 39 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To test the effectiveness of a single 20-30 minute motivational interviewing-based brief intervention for substance use within HIV/AIDS settings. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Substance Use
What is being tested?
Motivational Interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
827 participants
Where
39 sitesUnited States
Study dates
8 Jul 2015to 25 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Are unable to speak English.
  • Are unwilling to allow brief intervention sessions to be audio recorded.
  • Are unwilling to participate in the study.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Panhandle AIDS Support Organization

    Amarillo, Texas, 79101

  • Live Forward (AIDS Athens)

    Athens, Georgia, 30601

  • Triangle Area Network

    Beaumont, Texas, 77702

  • Vermont CARES

    Burlington, Vermont, 05401

  • Champaign-Urbana Public Health District (Collaborating Organization)

    Champaign, Illinois, 61820

  • Chattanooga CARES

    Chattanooga, Tennessee, 37403

  • Caracole House (Collaborating Organization)

    Cincinnati, Ohio, 45223

  • Foothill AIDS Project

    Claremont, California, 91711

  • ARC Ohio (Collaborating Organization)

    Columbus, Ohio, 43214

  • AIDS Project Greater Danbury, Inc.

    Danbury, Connecticut, 06810

  • The Project of the Quad Cities (Collaborating Organization)

    Davenport, Iowa, 52808

  • Health Emergency Lifeline Programs (Collaborating Organization)

    Detroit, Michigan, 48216

  • Community Health Awareness Group (Collaborating Organization)

    Detroit, Michigan, 48226

  • HIV Alliance

    Eugene, Oregon, 97403

  • AID Upstate

    Greenville, South Carolina, 29601

  • AIDS Connecticut, Inc

    Hartford, Connecticut, 06106

  • AIDS Foundation Houston

    Houston, Texas, 77057

  • AIDS Services Foundation, Orange County

    Irvine, California, 92614

  • Community AIDS Resources and Education Services (Collaborating Organization)

    Kalamazoo, Michigan, 49008

  • Southwest Louisiana AIDS Council

    Lake Charles, Louisiana, 70601

  • AIDS Volunteers, Inc. (AVOL)

    Lexington, Kentucky, 40504

  • AIDS Project Los Angeles

    Los Angeles, California, 90005

  • Project Response, Inc.

    Melbourne, Florida, 32901

  • Minnesota AIDS Project (Collaborating Organization)

    Minneapolis, Minnesota, 55404

  • Southern NH HIV/AIDS Task Force

    Nashua, New Hampshire, 03060

  • Nashville CARES

    Nashville, Tennessee, 37204

  • Nebraska AIDS Project (Collaborating Organization )

    Omaha, Nebraska, 68114

  • HIV Care Directions

    Phoenix, Arizona, 85014

  • Utah AIDS Foundation

    Salt Lake City, Utah, 84105

  • Alamo Area Resource Center

    San Antonio, Texas, 78207

  • Shanti

    San Francisco, California, 94109

  • Burrell Behavioral Health (Collaborating Organization)

    Springfield, Missouri, 65804

  • Doorways (Collaborating Organization)

    St Louis, Missouri, 63108

  • Places for People (Collaborating Organization)

    St Louis, Missouri, 63108

  • Project ARK

    St Louis, Missouri, 63110

  • St. Louis Effort for AIDS (Collaborating Organization)

    St Louis, Missouri, 63110

  • The Women's Collective

    Washington D.C., District of Columbia, 20020

  • Delaware HIV Consortium

    Wilmington, Delaware, 19801

  • AIDS Project Worcester

    Worcester, Massachusetts, 01604

Other trials in United States

About this study

Official title: 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.

Read the 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).

Conditions
Substance Use
Being tested
Motivational Interviewing
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational InterviewingBehavioural

    Participants assigned to the experimental condition receive a single 20-30 minute motivational interviewing-based brief intervention for substance use.

Study groups in NCT02495402
Study groupRoleWhat they receive
No Intervention: ControlNo interventionNo Intervention
Motivational InterviewingExperimentalA brief interview intervention for substance abuse
Receives: Behavioral: Motivational Interviewing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Days of Primary Substance Use

    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.

    Measured: 4 weeks post randomization

  2. Number of Substance-related problems

    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.

    Measured: 4 weeks post randomization

  3. Times engaging in risky behaviors

    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.

    Measured: 4 weeks post randomization

  4. Days of Substance Use Treatment

    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.

    Measured: 4 weeks post randomization

  5. ART Medication Adherence

    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.

    Measured: 4 weeks post randomization

Secondary outcomes (4)

  1. Urgency to Change

    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.

    Measured: 4 weeks post randomization

  2. Intentions to Change

    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.

    Measured: 4 weeks post randomization

  3. Commitment to Change

    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.

    Measured: 4 weeks post randomization

  4. Self-Efficacy to Change

    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.

    Measured: 4 weeks post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2015 (estimated)
  2. Study start8 Jul 2015
  3. Primary completion28 Dec 2017
  4. Study completion25 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
827 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02495402
Sponsor's protocol ID
SAT2HIV
Other IDs
R01DA038146
Status last verified
May 2018
First submitted
6 Jul 2015
Last updated
9 May 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34930497

  • 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.

    PubMed 29149914

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Interviewing in people with Substance Use, run by RTI International at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days of Primary Substance Use (time frame: 4 weeks post randomization). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02495402, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.

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