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

Substance Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495402
• Other study ID #: SAT2HIV
• Secondary ID: R01DA038146
• Status: Completed
• Phase: N/A
• Start date: July 8, 2015
• Est. completion date: March 25, 2018

Study information

• Verified date: May 2018
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 827
• Est. completion date: March 25, 2018
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Use
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Panhandle AIDS Support Organization	Amarillo	Texas
United States	Live Forward (AIDS Athens)	Athens	Georgia
United States	Triangle Area Network	Beaumont	Texas
United States	Vermont CARES	Burlington	Vermont
United States	Champaign-Urbana Public Health District (Collaborating Organization)	Champaign	Illinois
United States	Chattanooga CARES	Chattanooga	Tennessee
United States	Caracole House (Collaborating Organization)	Cincinnati	Ohio
United States	Foothill AIDS Project	Claremont	California
United States	ARC Ohio (Collaborating Organization)	Columbus	Ohio
United States	AIDS Project Greater Danbury, Inc.	Danbury	Connecticut
United States	The Project of the Quad Cities (Collaborating Organization)	Davenport	Iowa
United States	Community Health Awareness Group (Collaborating Organization)	Detroit	Michigan
United States	Health Emergency Lifeline Programs (Collaborating Organization)	Detroit	Michigan
United States	HIV Alliance	Eugene	Oregon
United States	AID Upstate	Greenville	South Carolina
United States	AIDS Connecticut, Inc	Hartford	Connecticut
United States	AIDS Foundation Houston	Houston	Texas
United States	AIDS Services Foundation, Orange County	Irvine	California
United States	Community AIDS Resources and Education Services (Collaborating Organization)	Kalamazoo	Michigan
United States	Southwest Louisiana AIDS Council	Lake Charles	Louisiana
United States	AIDS Volunteers, Inc. (AVOL)	Lexington	Kentucky
United States	AIDS Project Los Angeles	Los Angeles	California
United States	Project Response, Inc.	Melbourne	Florida
United States	Minnesota AIDS Project (Collaborating Organization)	Minneapolis	Minnesota
United States	Southern NH HIV/AIDS Task Force	Nashua	New Hampshire
United States	Nashville CARES	Nashville	Tennessee
United States	Nebraska AIDS Project (Collaborating Organization )	Omaha	Nebraska
United States	HIV Care Directions	Phoenix	Arizona
United States	Doorways (Collaborating Organization)	Saint Louis	Missouri
United States	Places for People (Collaborating Organization)	Saint Louis	Missouri
United States	Project ARK	Saint Louis	Missouri
United States	St. Louis Effort for AIDS (Collaborating Organization)	Saint Louis	Missouri
United States	Utah AIDS Foundation	Salt Lake City	Utah
United States	Alamo Area Resource Center	San Antonio	Texas
United States	Shanti	San Francisco	California
United States	Burrell Behavioral Health (Collaborating Organization)	Springfield	Missouri
United States	The Women's Collective	Washington	District of Columbia
United States	Delaware HIV Consortium	Wilmington	Delaware
United States	AIDS Project Worcester	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
RTI International	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks post randomization
Primary	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.	4 weeks post randomization
Primary	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.	4 weeks post randomization
Primary	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.	4 weeks post randomization
Primary	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.	4 weeks post randomization
Secondary	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.	4 weeks post randomization
Secondary	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.	4 weeks post randomization
Secondary	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.	4 weeks post randomization
Secondary	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.	4 weeks post randomization