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

NCT ID: NCT04687917

Last Updated: 2025-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

428 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-14

Study Completion Date

2026-05-31

Brief Summary

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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

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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

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Substance Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster-randomized trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
Single blind masking

Study Groups

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Facilitation, Training, Feedback, and Consultation (FTFC) Staff

A multilevel implementation strategy

Group Type ACTIVE_COMPARATOR

The facilitation, training, feedback, and consultation (FTFC) Strategy

Intervention Type BEHAVIORAL

A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation

Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff

An enhanced version of the multilevel implementation strategy

Group Type EXPERIMENTAL

The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy

Intervention Type BEHAVIORAL

A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization.

Facilitation, Training, Feedback, and Consultation (FTFC) Clients

Clients served within the context of a multilevel implementation strategy

Group Type ACTIVE_COMPARATOR

The facilitation, training, feedback, and consultation (FTFC) Strategy

Intervention Type BEHAVIORAL

A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation

Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Clients

Clients served within the context of an enhanced multilevel implementation strategy

Group Type EXPERIMENTAL

The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy

Intervention Type BEHAVIORAL

A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization.

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18+ years of age


* 18+ years of age
* Diagnosed with HIV

Exclusion Criteria

* None


\* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Alicia Bunger

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bryan R Garner, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40163072 (View on PubMed)

Garner 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.

Reference Type DERIVED
PMID: 39149465 (View on PubMed)

Garner 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.

Reference Type DERIVED
PMID: 38196639 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

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R01DA052294

Identifier Type: NIH

Identifier Source: secondary_id

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R01DA052294

Identifier Type: NIH

Identifier Source: org_study_id

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