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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02495402
Other study ID # SAT2HIV
Secondary ID R01DA038146
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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