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

Primary Purpose

Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Sponsored by
RTI International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Use

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • HIV Care Directions
  • Foothill AIDS Project
  • AIDS Services Foundation, Orange County
  • AIDS Project Los Angeles
  • Shanti
  • AIDS Project Greater Danbury, Inc.
  • AIDS Connecticut, Inc
  • Delaware HIV Consortium
  • The Women's Collective
  • Project Response, Inc.
  • Live Forward (AIDS Athens)
  • Champaign-Urbana Public Health District (Collaborating Organization)
  • The Project of the Quad Cities (Collaborating Organization)
  • AIDS Volunteers, Inc. (AVOL)
  • Southwest Louisiana AIDS Council
  • AIDS Project Worcester
  • Health Emergency Lifeline Programs (Collaborating Organization)
  • Community Health Awareness Group (Collaborating Organization)
  • Community AIDS Resources and Education Services (Collaborating Organization)
  • Minnesota AIDS Project (Collaborating Organization)
  • Doorways (Collaborating Organization)
  • Places for People (Collaborating Organization)
  • Project ARK
  • St. Louis Effort for AIDS (Collaborating Organization)
  • Burrell Behavioral Health (Collaborating Organization)
  • Nebraska AIDS Project (Collaborating Organization )
  • Southern NH HIV/AIDS Task Force
  • Caracole House (Collaborating Organization)
  • ARC Ohio (Collaborating Organization)
  • HIV Alliance
  • AID Upstate
  • Chattanooga CARES
  • Nashville CARES
  • Panhandle AIDS Support Organization
  • Triangle Area Network
  • AIDS Foundation Houston
  • Alamo Area Resource Center
  • Utah AIDS Foundation
  • Vermont CARES

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Intervention: Control

Motivational Interviewing

Arm Description

No Intervention

A brief interview intervention for substance abuse

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 6, 2015
Last Updated
May 7, 2018
Sponsor
RTI International
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02495402
Brief Title
Substance Abuse Treatment to HIV Care (SAT2HIV): The Motivational Interviewing-based Brief Intervention Experiment
Official Title
Substance Abuse Treatment to HIV Care (SAT2HIV): The Motivational Interviewing-based Brief Intervention (MIBI) Experiment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 8, 2015 (Actual)
Primary Completion Date
December 28, 2017 (Actual)
Study Completion Date
March 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RTI International
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To test the effectiveness of a single 20-30 minute motivational interviewing-based brief intervention for substance use within HIV/AIDS settings.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
827 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Intervention: Control
Arm Type
No Intervention
Arm Description
No Intervention
Arm Title
Motivational Interviewing
Arm Type
Experimental
Arm Description
A brief interview intervention for substance abuse
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
Participants assigned to the experimental condition receive a single 20-30 minute motivational interviewing-based brief intervention for substance use.
Primary Outcome Measure Information:
Title
Days of Primary Substance Use
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.
Time Frame
4 weeks post randomization
Title
Number of Substance-related problems
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.
Time Frame
4 weeks post randomization
Title
Times engaging in risky behaviors
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.
Time Frame
4 weeks post randomization
Title
Days of Substance Use Treatment
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.
Time Frame
4 weeks post randomization
Title
ART Medication Adherence
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.
Time Frame
4 weeks post randomization
Secondary Outcome Measure Information:
Title
Urgency to Change
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.
Time Frame
4 weeks post randomization
Title
Intentions to Change
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.
Time Frame
4 weeks post randomization
Title
Commitment to Change
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.
Time Frame
4 weeks post randomization
Title
Self-Efficacy to Change
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.
Time Frame
4 weeks post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan R Garner, PhD
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
HIV Care Directions
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Foothill AIDS Project
City
Claremont
State/Province
California
ZIP/Postal Code
91711
Country
United States
Facility Name
AIDS Services Foundation, Orange County
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
AIDS Project Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90005
Country
United States
Facility Name
Shanti
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
AIDS Project Greater Danbury, Inc.
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
AIDS Connecticut, Inc
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Delaware HIV Consortium
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19801
Country
United States
Facility Name
The Women's Collective
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20020
Country
United States
Facility Name
Project Response, Inc.
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Live Forward (AIDS Athens)
City
Athens
State/Province
Georgia
ZIP/Postal Code
30601
Country
United States
Facility Name
Champaign-Urbana Public Health District (Collaborating Organization)
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
The Project of the Quad Cities (Collaborating Organization)
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52808
Country
United States
Facility Name
AIDS Volunteers, Inc. (AVOL)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Southwest Louisiana AIDS Council
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
AIDS Project Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01604
Country
United States
Facility Name
Health Emergency Lifeline Programs (Collaborating Organization)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48216
Country
United States
Facility Name
Community Health Awareness Group (Collaborating Organization)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48226
Country
United States
Facility Name
Community AIDS Resources and Education Services (Collaborating Organization)
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
Facility Name
Minnesota AIDS Project (Collaborating Organization)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Doorways (Collaborating Organization)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Places for People (Collaborating Organization)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Project ARK
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis Effort for AIDS (Collaborating Organization)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Burrell Behavioral Health (Collaborating Organization)
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Nebraska AIDS Project (Collaborating Organization )
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Southern NH HIV/AIDS Task Force
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Caracole House (Collaborating Organization)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45223
Country
United States
Facility Name
ARC Ohio (Collaborating Organization)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
HIV Alliance
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Facility Name
AID Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Chattanooga CARES
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Nashville CARES
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Panhandle AIDS Support Organization
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79101
Country
United States
Facility Name
Triangle Area Network
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
AIDS Foundation Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Facility Name
Alamo Area Resource Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Utah AIDS Foundation
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84105
Country
United States
Facility Name
Vermont CARES
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34930497
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.
Results Reference
derived
PubMed Identifier
29149914
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. Erratum In: Addict Sci Clin Pract. 2018 Feb 21;13(1):9.
Results Reference
derived

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

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