Substance Use Clinical Trial
Official title:
Substance Abuse Treatment to HIV Care (SAT2HIV): The Motivational Interviewing-based Brief Intervention (MIBI) Experiment
Verified date | May 2018 |
Source | RTI International |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To test the effectiveness of a single 20-30 minute motivational interviewing-based brief intervention for substance use within HIV/AIDS settings.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
RTI International | National Institute on Drug Abuse (NIDA) |
United States,
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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