Substance UseSAT2HIV-IINCT04687917
The Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project
A study testing The facilitation, training, feedback, and consultation (FTFC) Strategy and The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy in people with Substance Use, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- The facilitation, training, feedback, and consultation (FTFC) Strategy and The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2021to 31 May 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18+ years of age
- 18+ years of age
- Diagnosed with HIV
Who cannot join
- None
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Substance Use
- Being tested
- The facilitation, training, feedback, and consultation (FTFC) Strategy, The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The facilitation, training, feedback, and consultation (FTFC) StrategyBehavioural
A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation
The facilitation, training, feedback, consultation, and incentivization (FTFCI) StrategyBehavioural
A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization.
| Study group | Role | What they receive |
|---|---|---|
| Facilitation, Training, Feedback, and Consultation (FTFC) Staff | Active comparator | A multilevel implementation strategy Receives: Behavioral: The facilitation, training, feedback, and consultation (FTFC) Strategy |
| Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff | Experimental | An enhanced version of the multilevel implementation strategy Receives: Behavioral: The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy |
| Facilitation, Training, Feedback, and Consultation (FTFC) Clients | Active comparator | Clients served within the context of a multilevel implementation strategy Receives: Behavioral: The facilitation, training, feedback, and consultation (FTFC) Strategy |
| Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Clients | Experimental | Clients served within the context of an enhanced multilevel implementation strategy Receives: Behavioral: The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Staff-level Implementation Consistency
The cumulative number of brief interventions that each HSO staff participant implemented with HSO client participants during the implementation phase.
Measured: Assessed at the end of month 12
Staff-level Implementation Quality
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.
Measured: Assessed at the end of month 12
Secondary outcomes (2)
Staff-level Average Change (Follow-up Minus Baseline) in Their Client Participant's Days Using Primary Substance
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
Measured: 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
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.
Measured: Assessed at 4-weeks from the baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start14 Jan 2021
- Primary completion30 Apr 2023
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Alicia Bunger, Ohio State University
- Investigators
- Bryan R Garner, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687917
- Sponsor's protocol ID
- R01DA052294
- Other IDs
- R01DA052294
- Acronym
- SAT2HIV-II
- Status last verified
- Oct 2025
- First submitted
- 18 Dec 2020
- Last updated
- 13 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After deidentification, all of the individual participant data collected during the trial.
Publications
Garner BR, Bouris A, Charlebois ED, Li DH, Dakin A, Moskowitz J, Benbow N, Christopoulos K, Hickey MD, Imbert E. The Strategies Timeline and Activities Reporting Tables: Improving HIV Care by Improving the Reporting of Implementation Strategies. J Acquir Immune Defic Syndr. 2025 Apr 15;98(5S):e205-e215. doi: 10.1097/QAI.0000000000003613.
PubMed 40163072Garner BR, Tueller SJ, Bradshaw M, Speck KJ, Satre D, Rash C, Donohoe T, Mungo J, Philbrick S, Ruwala R, Roosa MR, Zehner M, Ford JH 2nd. Testing the incremental effectiveness of pay-for-performance to improve implementation of a motivational interviewing brief intervention for substance use disorders in HIV settings: Results of a parallel cluster-randomized type 3 hybrid trial. Res Sq [Preprint]. 2024 Aug 9:rs.3.rs-4614222. doi: 10.21203/rs.3.rs-4614222/v1.
PubMed 39149465Garner BR, Tueller S, Bradshaw M, Speck K, Satre D, Rash C, Donohoe T, Mungo J, Philbrick S, Ruwala R, Roosa M, Zehner M, Ford J 2nd. Testing the incremental effectiveness of pay-for-performance to improve implementation of a motivational interviewing brief intervention for substance use disorders in HIV settings: Results of a cluster-randomized type 3 hybrid trial. Res Sq [Preprint]. 2023 Dec 20:rs.3.rs-3685134. doi: 10.21203/rs.3.rs-3685134/v1.
PubMed 38196639
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project
- ClinicalTrials.gov ID
- NCT04687917
- Acronym / sponsor ID
- SAT2HIV-II / R01DA052294
- Conditions
- Substance Use
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 29 Dec 2020 (actual)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Cluster-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Facilitation, Training, Feedback, and Consultation (FTFC) Staff | Active comparator | Behavioral: The facilitation, training, feedback, and consultation (FTFC) StrategyA multilevel implementation strategy |
| Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff | Experimental | Behavioral: The facilitation, training, feedback, consultation, and incentivization (FTFCI) StrategyAn enhanced version of the multilevel implementation strategy |
| Facilitation, Training, Feedback, and Consultation (FTFC) Clients | Active comparator | Behavioral: The facilitation, training, feedback, and consultation (FTFC) StrategyClients served within the context of a multilevel implementation strategy |
| Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Clients | Experimental | Behavioral: The facilitation, training, feedback, consultation, and incentivization (FTFCI) StrategyClients served within the context of an enhanced multilevel implementation strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18+ years of age
- Diagnosed with HIV
Key exclusion criteria (2 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The facilitation, training, feedback, and consultation (FTFC) StrategyA multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation | Behavioural | Facilitation, Training, Feedback, and Consultation (FTFC) Clients, Facilitation, Training, Feedback, and Consultation (FTFC) Staff |
| The facilitation, training, feedback, consultation, and incentivization (FTFCI) StrategyA multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization. | Behavioural | Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Clients, Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff |
Primary outcome
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.
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.
2 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40163072Garner BR, Bouris A, Charlebois ED, Li DH, Dakin A, Moskowitz J, Benbow N, Christopoulos K, Hickey MD, Imbert E. The Strategies Timeline and Activities Reporting Tables: Improving HIV Care by Improving the Reporting of Implementation Strategies. J Acquir Immune Defic Syndr. 2025 Apr 15;98(5S):e205-e215. doi: 10.1097/QAI.0000000000003613.
- Derived from this study: PubMed 39149465Garner BR, Tueller SJ, Bradshaw M, Speck KJ, Satre D, Rash C, Donohoe T, Mungo J, Philbrick S, Ruwala R, Roosa MR, Zehner M, Ford JH 2nd. Testing the incremental effectiveness of pay-for-performance to improve implementation of a motivational interviewing brief intervention for substance use disorders in HIV settings: Results of a parallel cluster-randomized type 3 hybrid trial. Res Sq [Preprint]. 2024 Aug 9:rs.3.rs-4614222. doi: 10.21203/rs.3.rs-4614222/v1.
- Derived from this study: PubMed 38196639Garner BR, Tueller S, Bradshaw M, Speck K, Satre D, Rash C, Donohoe T, Mungo J, Philbrick S, Ruwala R, Roosa M, Zehner M, Ford J 2nd. Testing the incremental effectiveness of pay-for-performance to improve implementation of a motivational interviewing brief intervention for substance use disorders in HIV settings: Results of a cluster-randomized type 3 hybrid trial. Res Sq [Preprint]. 2023 Dec 20:rs.3.rs-3685134. doi: 10.21203/rs.3.rs-3685134/v1.
- Individual participant dataSharing planned: Yes. After deidentification, all of the individual participant data collected during the trial.
Related trials for Substance Use
RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan R Garner, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The facilitation, training, feedback, and consultation (FTFC) Strategy and The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy in people with Substance Use, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Staff-level Implementation Consistency (time frame: Assessed at the end of month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04687917, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.