Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation (WHAT-IF?)

Yale University

Status: Completed

Conditions: Substance-related Disorders

Treatments: Behavioral: Implementation Facilitation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02907944

HIC1509016500

R01DA041067 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Tobacco, alcohol and opioid use disorders threaten the health of HIV-infected patients. What if evidence-based counseling and medication treatments for tobacco, alcohol and opioid use disorders (herein refered to as addiction treatments) were routinely provided in HIV clinics? Implementation Facilitation is an established strategy to increase the uptake of evidence-based treatments. Our goal is to evaluate the impact of Implementation Facilitation on the use of addiction treatments in four large HIV clinics.

The purpose of the WHAT-IF study is:

Aim 1. Among key stakeholders, to use quantitative and qualitative (mixed) methods to identify the site-specific evidence, context and facilitation-related barriers and facilitators to the integration of addiction treatments to help tailor an Implementation Facilitation for each clinic.

Aim 2. To evaluate the impact of Implementation Facilitation on:

2a: Organizational readiness to deliver addiction treatments 2b: Provider readiness to deliver addiction treatments 2c: Provision of addiction treatments 2d: Changes in organizational models of care used to deliver addiction treatments

Aim 3. To evaluate the impact of Implementation Facilitation on antiretroviral therapy receipt, HIV viral suppression, VACS Index, and retention in HIV care among patients eligible for addiction treatment.

Full description

The Working with HIV clinics to adopt Addiction Treatments using Implementation Facilitation (WHAT IF?) study will evaluate the impact of Implementation Facilitation on the adoption of addiction treatment services in four HIV clinics. We will use a stepped wedge design . The primary comparison is of the change that occurs from the pre-implementation period to two post-implementation periods, the initial six months (evaluation) and the following six months (maintenance). This proposal will consist of three main components in each of four clinics: 1) formative evaluation with key stakeholders at each site to guide and refine the Implementation Facilitation, 2) conduct of the Implementation Facilitation and 3) an evaluation of the impact of the Implementation Facilitation on organization and provider-level readiness, provision of addiction treatments, and HIV outcomes.

Enrollment: 3,838 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient inclusion criteria:

• HIV-infected
• Receiving HIV care in the index clinic
• Age >18 years old
• Meets criteria for lifetime or current tobacco, alcohol and/or opioid use disorder regardless of addiction treatment status
• Able to provide verbal informed consent

Staff inclusion criteria:

• Employed at participating HIV clinic for at least 6 months
• Able to provide verbal informed consent.

Payer/health insurance provider inclusion criteria:

• Employed at an organization or agency that provides funding for medical services for HIV-infected individuals for at least 6 months.
• Able to provide verbal informed consent.

Exclusion criteria

• Unable to provide verbal informed consent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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3,838 participants in 2 patient groups

Usual Care- Control

No Intervention group

Description:

We will use a stepped wedge design to evaluate the effect of the Implementation Facilitation on the outcomes. The first phase for all clinics is a control phase where clinic staff and patients engage in usual care. The time to implementation is randomly assigned. Each clinic is then followed prospectively to determine their outcome status.

Implementation Facilitation

Experimental group

Description:

We will use a stepped wedge design to evaluate the effect of the Implementation Facilitation on the outcomes. The time to implementation in a stepped wedge design is randomly assigned. Clinics are then followed prospectively to determine their outcome status..

Treatment:

Behavioral: Implementation Facilitation