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

Substance Use Clinical Trial

— SAT2HIV-II  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04687917
• Other study ID #: R01DA052294
• Secondary ID: R01DA052294
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 449
• Est. completion date: May 31, 2025
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• The facilitation, training, feedback, and consultation (FTFC) Strategy
A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation
• The facilitation, training, feedback, consultation, and pay-for-performance (FTFC+PFP) Strategy
A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and pay-for-performance.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implementation consistency	The cumulative number of brief interventions that each staff participant implemented during the implementation phase.	Assessed at the end of month 12
Primary	Implementation quality	The cumulative sum quality score that each staff participant demonstrated during the implementation phase.	Assessed at the end of month 12
Secondary	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
Secondary	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