Back to resultsThe Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project (SAT2HIV-II)
Primary Purpose
Substance Use
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The facilitation, training, feedback, and consultation (FTFC) Strategy
The facilitation, training, feedback, consultation, and pay-for-performance (FTFC+PFP) Strategy
Sponsored by
About this trial
This is an interventional health services research trial for Substance Use
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for staff participants:
- 18+ years of age
Inclusion criteria for client participants:
- 18+ years of age
- Diagnosed with HIV
Exclusion Criteria:
Exclusion criteria for staff participants:
- None
Exclusion criteria for client participants:
* None
Sites / Locations
- The Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Training, Feedback, Consultation, and Facilitation
Training, Feedback, Consultation, Facilitation, and P4P
Arm Description
A multilevel implementation strategy
An enhanced version of the multilevel implementation strategy
Outcomes
Primary Outcome Measures
Implementation consistency
The cumulative number of brief interventions that each staff participant implemented during the implementation phase.
Implementation quality
The cumulative sum quality score that each staff participant demonstrated during the implementation phase.
Secondary Outcome Measures
Days using primary substance
The number of days clients used their primary substance (i.e., the substance the client identified a willingness to talk about during the MIBI) during the past 28 day
Generalized Anxiety Disorder 7-item (GAD-7)
The sum of the 7 items including in the Generalized Anxiety Disorder 7-item (GAD-7), which ranges from 0 to 21 and where higher scores mean a worse outcome.
Full Information
NCT ID
NCT04687917
First Posted
December 18, 2020
Last Updated
May 9, 2023
Sponsor
Ohio State University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04687917
Brief Title
The Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project
Acronym
SAT2HIV-II
Official Title
The Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
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
An experiment to test the effectiveness of providing monetary bonuses to staff for achieving pre-defined performance targets regarding the implementation of a motivational interviewing-based brief intervention for substance use.
Detailed Description
A cluster-randomized type 3 hybrid trial with HIV service organizations across the United States. The primary aims is to test the effectiveness of an innovative pay-for-performance (P4P) strategy for improving the implementation of a motivational interviewing-based brief intervention for substance use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
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
Masking Description
Single blind masking
Allocation
Randomized
Enrollment
449 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training, Feedback, Consultation, and Facilitation
Arm Type
Active Comparator
Arm Description
A multilevel implementation strategy
Arm Title
Training, Feedback, Consultation, Facilitation, and P4P
Arm Type
Experimental
Arm Description
An enhanced version of the multilevel implementation strategy
Intervention Type
Behavioral
Intervention Name(s)
The facilitation, training, feedback, and consultation (FTFC) Strategy
Intervention Description
A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation
Intervention Type
Behavioral
Intervention Name(s)
The facilitation, training, feedback, consultation, and pay-for-performance (FTFC+PFP) Strategy
Intervention Description
A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and pay-for-performance.
Primary Outcome Measure Information:
Title
Implementation consistency
Description
The cumulative number of brief interventions that each staff participant implemented during the implementation phase.
Time Frame
Assessed at the end of month 12
Title
Implementation quality
Description
The cumulative sum quality score that each staff participant demonstrated during the implementation phase.
Time Frame
Assessed at the end of month 12
Secondary Outcome Measure Information:
Title
Days using primary substance
Description
The number of days clients used their primary substance (i.e., the substance the client identified a willingness to talk about during the MIBI) during the past 28 day
Time Frame
Assessed at 4-weeks from the baseline assessment
Title
Generalized Anxiety Disorder 7-item (GAD-7)
Description
The sum of the 7 items including in the Generalized Anxiety Disorder 7-item (GAD-7), which ranges from 0 to 21 and where higher scores mean a worse outcome.
Time Frame
Assessed at 4-weeks from the baseline assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for staff participants:
18+ years of age
Inclusion criteria for client participants:
18+ years of age
Diagnosed with HIV
Exclusion Criteria:
Exclusion criteria for staff participants:
None
Exclusion criteria for client participants:
* None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan R Garner, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After deidentification, all of the individual participant data collected during the trial.
IPD Sharing Time Frame
After study completion
IPD Sharing Access Criteria
Anyone who wishes to access the data.
IPD Sharing URL
https://www.icpsr.umich.edu/web/pages/NAHDAP/index.html
Learn more about this trial
The Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project
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