The Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project

Conditions
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Substance Use

Intervention / Treatment
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* Behavioral: The facilitation, training, feedback, and consultation (FTFC) Strategy
* Behavioral: The facilitation, training, feedback, consultation, and pay-for-performance (FTFC+PFP) Strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster-randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Training, Feedback, Consultation, and Facilitation<br>A multilevel implementation strategy | Behavioral: The facilitation, training, feedback, and consultation (FTFC) Strategy<br>* A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation<br>|
| Experimental: Training, Feedback, Consultation, Facilitation, and P4P<br>An enhanced version of the multilevel implementation strategy | Behavioral: The facilitation, training, feedback, consultation, and pay-for-performance (FTFC+PFP) Strategy<br>* A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and pay-for-performance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation consistency | The cumulative number of brief interventions that each staff participant implemented during the implementation phase. | Assessed at the end of month 12 | 
| Implementation quality | The cumulative sum quality score that each staff participant demonstrated during the implementation phase. | Assessed at the end of month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Assessed at 4-weeks from the baseline assessment | 
| 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. | Assessed at 4-weeks from the baseline assessment |