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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
428

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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