Substance UseNCT03120598
Substance Abuse Treatment to HIV Care (SAT2HIV): The Implementation & Sustainment Facilitation Experiment
A study testing ATTC strategy and ISF strategy in people with Substance Use, run by RTI International at 39 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use
- What is being tested?
- ATTC strategy and ISF strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 39 sitesUnited States
- Study dates
- 5 Jan 2015to 22 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Panhandle AIDS Support Organization
Amarillo, Texas, 79101
Live Forward (AIDS Athens)
Athens, Georgia, 30601
Triangle Area Network
Beaumont, Texas, 77702
Vermont CARES
Burlington, Vermont, 05402
Champaign-Urbana Public Health District (CUPHD)
Champaign, Illinois, 61820
Chattanooga CARES
Chattanooga, Tennessee, 37403
Caracole House
Cincinnati, Ohio, 45223
Foothill AIDS Project
Claremont, California, 91711
ARC Ohio
Columbus, Ohio, 43214
AIDS Project Greater Danbury, Inc.
Danbury, Connecticut, 06810
The Project of the Quad Cities (TPQC)
Davenport, Iowa, 52808
Health Emergency Lifeline Programs (HELP)
Detroit, Michigan, 48216
Community Health Awareness Group (CHAG)
Detroit, Michigan, 48226
HIV Alliance
Eugene, Oregon, 97403
AID Upstate
Greenville, South Carolina, 29601
AIDS Connecticut, Inc.
Hartford, Connecticut, 06106
AIDS Foundation Houston
Houston, Texas, 77057
AIDS Services Foundation, Orange County
Irvine, California, 92614
Community AIDS Resources and Education Services (CARES)
Kalamazoo, Michigan, 49008
Southwest Louisiana AIDS Council
Lake Charles, Louisiana, 70601
AIDS Volunteers, Inc. (AVOL)
Lexington, Kentucky, 40504
AIDS Project Los Angeles
Los Angeles, California, 90005
Project Response, Inc.
Melbourne, Florida, 32901
Minnesota AIDS Project
Minneapolis, Minnesota, 55404
Southern NH HIV/AIDS Task Force a.k.a. NH Partnership
Nashua, New Hampshire, 03060
Nashville CARES
Nashville, Tennessee, 37204
Nebraska AIDS Project (NAP)
Omaha, Nebraska, 68114
HIV Care Directions
Phoenix, Arizona, 85014
Utah AIDS Foundation
Salt Lake City, Utah, 84105
Alamo Area Resource Center
San Antonio, Texas, 78207
Shanti
San Francisco, California, 94109
Burrell Behavioral Health
Springfield, Missouri, 65804
Doorways
St Louis, Missouri, 63108
Places for People (p4p)
St Louis, Missouri, 63108
Project ARK
St Louis, Missouri, 63110
St. Louis Effort For AIDS (EFA)
St Louis, Missouri, 63110
The Women's Collective
Washington D.C., District of Columbia, 20020
Delaware HIV Consortium
Wilmington, Delaware, 19801
AIDS Project Worcester
Worcester, Massachusetts, 01604
About this study
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.
Read the 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.
- Conditions
- Substance Use
- Being tested
- ATTC strategy, ISF strategy
- Keywords
- preparation strategies, implementation strategies, sustainment strategies
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATTC strategyBehavioural
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).
ISF strategyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| ATTC strategy | Active comparator | 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). Receives: Behavioral: ATTC strategy |
| ISF strategy | Experimental | 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). Receives: Behavioral: ATTC strategy; Behavioral: ISF strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at the end of the 2-month post-workshop preparation phase
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).
Measured: Assessed at the end of the 6-month implementation phase
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.
Measured: Assessed at the end of the 6-month sustainment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start5 Jan 2015
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Bryan Garner, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120598
- Sponsor's protocol ID
- SAT2HIV-ISF
- Other IDs
- R01DA038146
- Status last verified
- Oct 2018
- First submitted
- 18 Apr 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29149909
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Abuse Treatment to HIV Care (SAT2HIV): The Implementation & Sustainment Facilitation Experiment
- ClinicalTrials.gov ID
- NCT03120598
- Acronym / sponsor ID
- SAT2HIV-ISF
- Conditions
- Substance Use
- Keywords
- preparation strategies, implementation strategies, sustainment strategies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 5 Jan 2015 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| ATTC strategy | Active comparator | Behavioral: ATTC strategyBehavioral: 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). |
| ISF strategy | Experimental | Behavioral: ATTC strategy, Behavioral: ISF strategyBehavioral: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AIDS service organizations have to
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATTC strategyAddiction 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). | Behavioural | ATTC strategy, ISF strategy |
| ISF strategyImplementation \& 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). | Behavioural | ISF strategy |
Primary outcome
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.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 29149909Garner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Garner, PhD principal investigator
RTI International
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATTC strategy and ISF strategy in people with Substance Use, run by RTI International at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-Proficiency (TTP) Score (time frame: Assessed at the end of the 2-month post-workshop preparation phase). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03120598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.