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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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
      • 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
      • Washington, District of Columbia, United States, 20020
        • The Women's Collective
    • Florida
      • Melbourne, Florida, United States, 32901
        • Project Response, Inc.
    • Georgia
      • Athens, Georgia, United States, 30601
        • Live Forward (AIDS Athens)
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Champaign-Urbana Public Health District (CUPHD)
    • Iowa
      • Davenport, Iowa, United States, 52808
        • The Project of the Quad Cities (TPQC)
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • AIDS Volunteers, Inc. (AVOL)
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Southwest Louisiana AIDS Council
    • Massachusetts
      • 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)
      • Kalamazoo, Michigan, United States, 49008
        • Community AIDS Resources and Education Services (CARES)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota AIDS Project
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Doorways
      • Saint Louis, Missouri, United States, 63108
        • Places for People (p4p)
      • Saint Louis, Missouri, United States, 63110
        • Project ARK
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Effort For AIDS (EFA)
      • Springfield, Missouri, United States, 65804
        • Burrell Behavioral Health
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska AIDS Project (NAP)
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Southern NH HIV/AIDS Task Force a.k.a. NH Partnership
    • Ohio
      • Cincinnati, Ohio, United States, 45223
        • Caracole House
      • Columbus, Ohio, United States, 43214
        • ARC Ohio
    • Oregon
      • Eugene, Oregon, United States, 97403
        • HIV Alliance
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • AID Upstate
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Chattanooga CARES
      • Nashville, Tennessee, United States, 37204
        • Nashville CARES
    • Texas
      • Amarillo, Texas, United States, 79101
        • Panhandle AIDS Support Organization
      • Beaumont, Texas, United States, 77702
        • Triangle Area Network
      • Houston, Texas, United States, 77057
        • AIDS Foundation Houston
      • San Antonio, Texas, United States, 78207
        • Alamo Area Resource Center
    • Utah
      • Salt Lake City, Utah, United States, 84105
        • Utah AIDS Foundation
    • Vermont
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Behavioral: ATTC strategy
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).
Behavioral: ATTC strategy
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: ISF strategy
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RTI International

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 22, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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