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Clinical Trials/NCT02495402
NCT02495402CompletedNot Applicable

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

RTI International78 sites in 1 country827 target enrollmentStarted: July 8, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
827
Locations
78
Primary Endpoint
Days of Primary Substance Use

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

Secondary Outcomes

  • Intentions to Change(4 weeks post randomization)
  • Urgency to Change(4 weeks post randomization)
  • Self-Efficacy to Change(4 weeks post randomization)
  • Commitment to Change(4 weeks post randomization)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (78)

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