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Substance Abuse Treatment to HIV Care (SAT2HIV): The Implementation & Sustainment Facilitation Experiment

Primary Purpose

Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ATTC strategy
ISF strategy
Sponsored by
RTI International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Use focused on measuring preparation strategies, implementation strategies, sustainment strategies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • AIDS service organizations have to

    1. serve a minimum of 100 individuals living with HIV/AIDS per year,
    2. 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

    3. 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:

Sites / Locations

  • HIV Care Directions
  • Foothill AIDS Project
  • AIDS Services Foundation, Orange County
  • AIDS Project Los Angeles
  • Shanti
  • AIDS Project Greater Danbury, Inc.
  • AIDS Connecticut, Inc.
  • Delaware HIV Consortium
  • The Women's Collective
  • Project Response, Inc.
  • Live Forward (AIDS Athens)
  • Champaign-Urbana Public Health District (CUPHD)
  • The Project of the Quad Cities (TPQC)
  • AIDS Volunteers, Inc. (AVOL)
  • Southwest Louisiana AIDS Council
  • AIDS Project Worcester
  • Health Emergency Lifeline Programs (HELP)
  • Community Health Awareness Group (CHAG)
  • Community AIDS Resources and Education Services (CARES)
  • Minnesota AIDS Project
  • Doorways
  • Places for People (p4p)
  • Project ARK
  • St. Louis Effort For AIDS (EFA)
  • Burrell Behavioral Health
  • Nebraska AIDS Project (NAP)
  • Southern NH HIV/AIDS Task Force a.k.a. NH Partnership
  • Caracole House
  • ARC Ohio
  • HIV Alliance
  • AID Upstate
  • Chattanooga CARES
  • Nashville CARES
  • Panhandle AIDS Support Organization
  • Triangle Area Network
  • AIDS Foundation Houston
  • Alamo Area Resource Center
  • Utah AIDS Foundation
  • Vermont CARES

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ATTC strategy

ISF strategy

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Time-to-Proficiency (TTP) Score
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.
Implementation Effectiveness Index (IEI) Score
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).
Level of Sustainment (LOS) Score
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.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2017
Last Updated
October 5, 2018
Sponsor
RTI International
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03120598
Brief Title
Substance Abuse Treatment to HIV Care (SAT2HIV): The Implementation & Sustainment Facilitation Experiment
Official Title
Substance Abuse Treatment to HIV Care (SAT2HIV): The Implementation & Sustainment Facilitation Experiment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 5, 2015 (Actual)
Primary Completion Date
August 22, 2018 (Actual)
Study Completion Date
August 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RTI International
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
Keywords
preparation strategies, implementation strategies, sustainment strategies

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster Randomized Trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATTC strategy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
ISF strategy
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
ATTC strategy
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
ISF strategy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Time-to-Proficiency (TTP) Score
Description
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.
Time Frame
Assessed at the end of the 2-month post-workshop preparation phase
Title
Implementation Effectiveness Index (IEI) Score
Description
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).
Time Frame
Assessed at the end of the 6-month implementation phase
Title
Level of Sustainment (LOS) Score
Description
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.
Time Frame
Assessed at the end of the 6-month sustainment phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Garner, PhD
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
HIV Care Directions
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Foothill AIDS Project
City
Claremont
State/Province
California
ZIP/Postal Code
91711
Country
United States
Facility Name
AIDS Services Foundation, Orange County
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
AIDS Project Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90005
Country
United States
Facility Name
Shanti
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
AIDS Project Greater Danbury, Inc.
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
AIDS Connecticut, Inc.
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Delaware HIV Consortium
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19801
Country
United States
Facility Name
The Women's Collective
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20020
Country
United States
Facility Name
Project Response, Inc.
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Live Forward (AIDS Athens)
City
Athens
State/Province
Georgia
ZIP/Postal Code
30601
Country
United States
Facility Name
Champaign-Urbana Public Health District (CUPHD)
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
The Project of the Quad Cities (TPQC)
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52808
Country
United States
Facility Name
AIDS Volunteers, Inc. (AVOL)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Southwest Louisiana AIDS Council
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
AIDS Project Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01604
Country
United States
Facility Name
Health Emergency Lifeline Programs (HELP)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48216
Country
United States
Facility Name
Community Health Awareness Group (CHAG)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48226
Country
United States
Facility Name
Community AIDS Resources and Education Services (CARES)
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
Facility Name
Minnesota AIDS Project
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Doorways
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Places for People (p4p)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Project ARK
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis Effort For AIDS (EFA)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Burrell Behavioral Health
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Nebraska AIDS Project (NAP)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Southern NH HIV/AIDS Task Force a.k.a. NH Partnership
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Caracole House
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45223
Country
United States
Facility Name
ARC Ohio
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
HIV Alliance
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Facility Name
AID Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Chattanooga CARES
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Nashville CARES
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Panhandle AIDS Support Organization
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79101
Country
United States
Facility Name
Triangle Area Network
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
AIDS Foundation Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Facility Name
Alamo Area Resource Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Utah AIDS Foundation
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84105
Country
United States
Facility Name
Vermont CARES
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05402
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29149909
Citation
Garner BR, Zehner M, Roosa MR, Martino S, Gotham HJ, Ball EL, Stilen P, Speck K, Vandersloot D, Rieckmann TR, Chaple M, Martin EG, Kaiser D, Ford JH 2nd. Testing the implementation and sustainment facilitation (ISF) strategy as an effective adjunct to the Addiction Technology Transfer Center (ATTC) strategy: study protocol for a cluster randomized trial. Addict Sci Clin Pract. 2017 Nov 17;12(1):32. doi: 10.1186/s13722-017-0096-7.
Results Reference
derived

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Substance Abuse Treatment to HIV Care (SAT2HIV): The Implementation & Sustainment Facilitation Experiment

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