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OpenTrials
Active, Not Recruiting

NCT Number: NCT04687917

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Substance Use Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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) Strategy

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: SAT2HIV-II

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Dec 29, 2020
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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