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

October 29, 2025 updated by: Alicia Bunger, Ohio State University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

428

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Facilitation, Training, Feedback, and Consultation (FTFC) Staff
A multilevel implementation strategy
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
Experimental: Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff
An enhanced version of the multilevel implementation strategy
Behavioral: The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy
A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization.
Active Comparator: Facilitation, Training, Feedback, and Consultation (FTFC) Clients
Clients served within the context of a multilevel implementation strategy
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
Experimental: Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Clients
Clients served within the context of an enhanced multilevel implementation strategy
Behavioral: The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy
A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staff-level Implementation Consistency
Time Frame: Assessed at the end of month 12
The cumulative number of brief interventions that each HSO staff participant implemented with HSO client participants during the implementation phase.
Assessed at the end of month 12
Staff-level Implementation Quality
Time Frame: Assessed at the end of month 12
The cumulative sum quality score that each HSO staff participant demonstrated during the implementation phase. Each motivational interviewing brief intervention (MIBI) is rated on a scale from 0 (zero quality) to 12 (highest quality possible). Each individual MIBI quality score is summed to create a cumulative sum quality score. Higher scores indicated higher quality (i.e. motivational interviewing fidelity). The lower limit is zero. There is not an upper limit.
Assessed at the end of month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staff-level Average Change (Follow-up Minus Baseline) in Their Client Participant's Days Using Primary Substance
Time Frame: Assessed at 4-weeks from the baseline assessment
A staff-level measure representing the average level of client participant change (follow-up minus baseline) in 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
Staff-level Average Change (Follow-up Minus Baseline) in Their Client Participant's Generalized Anxiety Disorder 7-item (GAD-7) Score
Time Frame: Assessed at 4-weeks from the baseline assessment
A staff-level measure of the average change (follow-up minus baseline) in their client participant's Generalized Anxiety Disorder 7-item (GAD-7) scale score. The GAD-7 ranges from 0 to 21, with higher scores indicating greater generalized anxiety. For change in the GAD-7 between baseline and follow-up (follow-up minus baseline), scores range from -20 to 20 and negative numbers are better as they indicate decreasing generalized anxiety. For this study, we examined the average GAD-7 change score that the HSO staff had with their client participants.
Assessed at 4-weeks from the baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Bryan R Garner, PhD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2021

Primary Completion (Actual)

April 30, 2023

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

December 18, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Estimated)

November 13, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA052294 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Substance Use

Clinical Trials on The facilitation, training, feedback, and consultation (FTFC) Strategy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe