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NCT04687917 Clinical Trial

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
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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