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

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ClinicalTrials.gov Identifier: NCT02495402
Recruitment Status : Completed
First Posted : July 13, 2015
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
RTI International

Tracking Information
First Submitted Date  ICMJE July 6, 2015
First Posted Date  ICMJE July 13, 2015
Last Update Posted Date May 9, 2018
Actual Study Start Date  ICMJE July 8, 2015
Actual Primary Completion Date December 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2015)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2015)
  • Urgency to Change [ Time Frame: 4 weeks post randomization ]
    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 [ Time Frame: 4 weeks post randomization ]
    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 [ Time Frame: 4 weeks post randomization ]
    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 [ Time Frame: 4 weeks post randomization ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Substance Abuse Treatment to HIV Care (SAT2HIV): The Motivational Interviewing-based Brief Intervention Experiment
Official Title  ICMJE Substance Abuse Treatment to HIV Care (SAT2HIV): The Motivational Interviewing-based Brief Intervention (MIBI) Experiment
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Substance Use
Intervention  ICMJE Behavioral: Motivational Interviewing
Participants assigned to the experimental condition receive a single 20-30 minute motivational interviewing-based brief intervention for substance use.
Study Arms  ICMJE
  • No Intervention: No Intervention: Control
    No Intervention
  • Experimental: Motivational Interviewing
    A brief interview intervention for substance abuse
    Intervention: Behavioral: Motivational Interviewing
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2018)
827
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2015)
2592
Actual Study Completion Date  ICMJE March 25, 2018
Actual Primary Completion Date December 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02495402
Other Study ID Numbers  ICMJE SAT2HIV
R01DA038146 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party RTI International
Study Sponsor  ICMJE RTI International
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Bryan R Garner, PhD RTI International
PRS Account RTI International
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP