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

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

Detailed Description
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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).

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

Conditions
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Substance Use

Intervention / Treatment
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* Behavioral: Motivational Interviewing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Intervention: Control<br>No Intervention | |
| Experimental: Motivational Interviewing<br>A brief interview intervention for substance abuse | Behavioral: Motivational Interviewing<br>* Participants assigned to the experimental condition receive a single 20-30 minute motivational interviewing-based brief intervention for substance use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |