Clinical trial NCT02495402: 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
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-07-13
Enrollment: 827
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Primary outcomes:
measure: Days of Primary Substance Use
timeFrame: 4 weeks post randomization
measure: Number of Substance-related problems
timeFrame: 4 weeks post randomization
measure: Times engaging in risky behaviors
timeFrame: 4 weeks post randomization
measure: Days of Substance Use Treatment
timeFrame: 4 weeks post randomization
measure: ART Medication Adherence
timeFrame: 4 weeks post randomization
Secondary outcomes:
measure: Urgency to Change
timeFrame: 4 weeks post randomization
measure: Intentions to Change
timeFrame: 4 weeks post randomization
measure: Commitment to Change
timeFrame: 4 weeks post randomization
measure: Self-Efficacy to Change
timeFrame: 4 weeks post randomization
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HIV Care Directions
state: Arizona
city: Claremont
country: United States
facility: Foothill AIDS Project
state: California
city: Irvine
country: United States
facility: AIDS Services Foundation, Orange County
state: California
city: Los Angeles
country: United States
facility: AIDS Project Los Angeles
state: California
city: San Francisco
country: United States
facility: Shanti
state: California
city: Danbury
country: United States
facility: AIDS Project Greater Danbury, Inc.
state: Connecticut
city: Hartford
country: United States
facility: AIDS Connecticut, Inc
state: Connecticut
city: Wilmington
country: United States
facility: Delaware HIV Consortium
state: Delaware
city: Washington
country: United States
facility: The Women's Collective
state: District of Columbia
city: Melbourne
country: United States
facility: Project Response, Inc.
state: Florida
city: Athens
country: United States
facility: Live Forward (AIDS Athens)
state: Georgia
city: Champaign
country: United States
facility: Champaign-Urbana Public Health District (Collaborating Organization)
state: Illinois
city: Davenport
country: United States
facility: The Project of the Quad Cities (Collaborating Organization)
state: Iowa
city: Lexington
country: United States
facility: AIDS Volunteers, Inc. (AVOL)
state: Kentucky
city: Lake Charles
country: United States
facility: Southwest Louisiana AIDS Council
state: Louisiana
city: Worcester
country: United States
facility: AIDS Project Worcester
state: Massachusetts
city: Detroit
country: United States
facility: Health Emergency Lifeline Programs (Collaborating Organization)
state: Michigan
city: Detroit
country: United States
facility: Community Health Awareness Group (Collaborating Organization)
state: Michigan
city: Kalamazoo
country: United States
facility: Community AIDS Resources and Education Services (Collaborating Organization)
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota AIDS Project (Collaborating Organization)
state: Minnesota
city: Saint Louis
country: United States
facility: Doorways (Collaborating Organization)
state: Missouri
city: Saint Louis
country: United States
facility: Places for People (Collaborating Organization)
state: Missouri
city: Saint Louis
country: United States
facility: Project ARK
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Effort for AIDS (Collaborating Organization)
state: Missouri
city: Springfield
country: United States
facility: Burrell Behavioral Health (Collaborating Organization)
state: Missouri
city: Omaha
country: United States
facility: Nebraska AIDS Project (Collaborating Organization )
state: Nebraska
city: Nashua
country: United States
facility: Southern NH HIV/AIDS Task Force
state: New Hampshire
city: Cincinnati
country: United States
facility: Caracole House (Collaborating Organization)
state: Ohio
city: Columbus
country: United States
facility: ARC Ohio (Collaborating Organization)
state: Ohio
city: Eugene
country: United States
facility: HIV Alliance
state: Oregon
city: Greenville
country: United States
facility: AID Upstate
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga CARES
state: Tennessee
city: Nashville
country: United States
facility: Nashville CARES
state: Tennessee
city: Amarillo
country: United States
facility: Panhandle AIDS Support Organization
state: Texas
city: Beaumont
country: United States
facility: Triangle Area Network
state: Texas
city: Houston
country: United States
facility: AIDS Foundation Houston
state: Texas
city: San Antonio
country: United States
facility: Alamo Area Resource Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah AIDS Foundation
state: Utah
city: Burlington
country: United States
facility: Vermont CARES
state: Vermont
Study officials:
affiliation: RTI International
name: Bryan R Garner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.