- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03120598
Substance Abuse Treatment to HIV Care (SAT2HIV): The Implementation & Sustainment Facilitation Experiment
October 5, 2018 updated by: RTI International
A cluster randomized experiment focused on testing the extent to which the organization-focused Implementation & Sustainment Facilitation (ISF) strategy is an effective adjunct to the staff-focused Addiction Technology Transfer Center (ATTC) strategy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A cluster randomized experiment with 39 AIDS service organizations located across the United States.
The overarching goal is to test the extent to which the organization-focused Implementation & Sustainment Facilitation (ISF) strategy is an effective adjunct to the staff-focused Addiction Technology Transfer Center (ATTC) strategy.
Study Type
Interventional
Enrollment (Actual)
190
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85014
- HIV Care Directions
-
-
California
-
Claremont, California, United States, 91711
- Foothill AIDS Project
-
Irvine, California, United States, 92614
- AIDS Services Foundation, Orange County
-
Los Angeles, California, United States, 90005
- AIDS Project Los Angeles
-
San Francisco, California, United States, 94109
- Shanti
-
-
Connecticut
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Danbury, Connecticut, United States, 06810
- AIDS Project Greater Danbury, Inc.
-
Hartford, Connecticut, United States, 06106
- AIDS Connecticut, Inc.
-
-
Delaware
-
Wilmington, Delaware, United States, 19801
- Delaware HIV Consortium
-
-
District of Columbia
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Washington, District of Columbia, United States, 20020
- The Women's Collective
-
-
Florida
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Melbourne, Florida, United States, 32901
- Project Response, Inc.
-
-
Georgia
-
Athens, Georgia, United States, 30601
- Live Forward (AIDS Athens)
-
-
Illinois
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Champaign, Illinois, United States, 61820
- Champaign-Urbana Public Health District (CUPHD)
-
-
Iowa
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Davenport, Iowa, United States, 52808
- The Project of the Quad Cities (TPQC)
-
-
Kentucky
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Lexington, Kentucky, United States, 40504
- AIDS Volunteers, Inc. (AVOL)
-
-
Louisiana
-
Lake Charles, Louisiana, United States, 70601
- Southwest Louisiana AIDS Council
-
-
Massachusetts
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Worcester, Massachusetts, United States, 01604
- AIDS Project Worcester
-
-
Michigan
-
Detroit, Michigan, United States, 48216
- Health Emergency Lifeline Programs (HELP)
-
Detroit, Michigan, United States, 48226
- Community Health Awareness Group (CHAG)
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Kalamazoo, Michigan, United States, 49008
- Community AIDS Resources and Education Services (CARES)
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55404
- Minnesota AIDS Project
-
-
Missouri
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Saint Louis, Missouri, United States, 63108
- Doorways
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Saint Louis, Missouri, United States, 63108
- Places for People (p4p)
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Saint Louis, Missouri, United States, 63110
- Project ARK
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Saint Louis, Missouri, United States, 63110
- St. Louis Effort For AIDS (EFA)
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Springfield, Missouri, United States, 65804
- Burrell Behavioral Health
-
-
Nebraska
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Omaha, Nebraska, United States, 68114
- Nebraska AIDS Project (NAP)
-
-
New Hampshire
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Nashua, New Hampshire, United States, 03060
- Southern NH HIV/AIDS Task Force a.k.a. NH Partnership
-
-
Ohio
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Cincinnati, Ohio, United States, 45223
- Caracole House
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Columbus, Ohio, United States, 43214
- ARC Ohio
-
-
Oregon
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Eugene, Oregon, United States, 97403
- HIV Alliance
-
-
South Carolina
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Greenville, South Carolina, United States, 29601
- AID Upstate
-
-
Tennessee
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Chattanooga, Tennessee, United States, 37403
- Chattanooga CARES
-
Nashville, Tennessee, United States, 37204
- Nashville CARES
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-
Texas
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Amarillo, Texas, United States, 79101
- Panhandle AIDS Support Organization
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Beaumont, Texas, United States, 77702
- Triangle Area Network
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Houston, Texas, United States, 77057
- AIDS Foundation Houston
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San Antonio, Texas, United States, 78207
- Alamo Area Resource Center
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-
Utah
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Salt Lake City, Utah, United States, 84105
- Utah AIDS Foundation
-
-
Vermont
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Burlington, Vermont, United States, 05402
- Vermont CARES
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
AIDS service organizations have to
- serve a minimum of 100 individuals living with HIV/AIDS per year,
- have at least two frontline staff who were willing and able to be trained in the Motivational Interviewing-based Brief Intervention (MIBI) Experiment's MIBI for substance use, and
have at least one leadership staff (i.e., supervisor, manager, director) willing and able to help ensure case-managers were given sufficient time for project participation.
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ATTC strategy
Behavioral: Addiction Technology Transfer Center (ATTC) strategy: A staff-focused strategy that includes 10 discrete strategies (e.g., centralized technical assistance, conduct educational meetings, provide ongoing consultation).
|
Addiction Technology Transfer Center (ATTC) strategy: A staff-focused strategy that includes 10 discrete strategies (e.g., centralized technical assistance, conduct educational meetings, provide ongoing consultation).
|
Experimental: ISF strategy
Behavioral: Implementation & Sustainment Facilitation (ISF) strategy: An organization-focused strategy that includes 7 discrete strategies (e.g., use of an implementation advisor, organize implementation team meetings, conduct cyclical small tests of change) and Addiction Technology Transfer Center (ATTC) strategy: A staff-focused strategy that includes 10 discrete strategies (e.g., centralized technical assistance, conduct educational meetings, provide ongoing consultation).
|
Addiction Technology Transfer Center (ATTC) strategy: A staff-focused strategy that includes 10 discrete strategies (e.g., centralized technical assistance, conduct educational meetings, provide ongoing consultation).
Implementation & Sustainment Facilitation (ISF) strategy: An organization-focused strategy that includes 7 discrete strategies (e.g., use of an implementation advisor, organize implementation team meetings, conduct cyclical small tests of change).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time-to-Proficiency (TTP) Score
Time Frame: Assessed at the end of the 2-month post-workshop preparation phase
|
A continuous measure representing the number of days between completion of the training workshop by targeted staff and targeted staff's demonstration of proficiency in the motivational interviewing-based brief intervention.
|
Assessed at the end of the 2-month post-workshop preparation phase
|
Implementation Effectiveness Index (IEI) Score
Time Frame: Assessed at the end of the 6-month implementation phase
|
A continuous measure representing the sum of the standardized cumulative number of motivational interviewing brief interventions delivered by targeted staff (i.e., consistency) and the cumulative integrity score of targeted staff's delivered of the motivational interviewing-based brief intervention (i.e., quality).
|
Assessed at the end of the 6-month implementation phase
|
Level of Sustainment (LOS) Score
Time Frame: Assessed at the end of the 6-month sustainment phase
|
A continuous measure representing the number of Motivational Interviewing-based Brief Interventions targeted Brief Intervention Staff report delivery of the motivational interviewing-based brief intervention during the past 6-months following the end of the implementation phase.
|
Assessed at the end of the 6-month sustainment phase
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bryan Garner, PhD, RTI International
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2015
Primary Completion (Actual)
August 22, 2018
Study Completion (Actual)
August 22, 2018
Study Registration Dates
First Submitted
April 18, 2017
First Submitted That Met QC Criteria
April 18, 2017
First Posted (Actual)
April 19, 2017
Study Record Updates
Last Update Posted (Actual)
October 9, 2018
Last Update Submitted That Met QC Criteria
October 5, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAT2HIV-ISF
- R01DA038146 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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