Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation

NCT ID: NCT02907944

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3838 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2021-09-30

Brief Summary

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.

Detailed 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.

Conditions

Substance-related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care- Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Implementation Facilitation

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..

Group Type: EXPERIMENTAL

Implementation Facilitation

Intervention Type: BEHAVIORAL

Implementation Facilitation is an evidence-based strategy tailored to the specific needs of the clinic, designed to increase uptake of evidence based treatments for tobacco, alcohol and opioid use disorders. Will include provider education and academic detailing.

• External Facilitator: Outside content expert who assists site
• Local Champion: Site stakeholder who promotes change
• Provider Education and Academic Detailing: Provision of unbiased peer education
• Stakeholder Engagement: Aligning goals of implementation and those impacted
• Tailor Program to Site: Addressing site specific needs based on Aim 1
• Performance Monitoring and Feedback: Assess implementation of screening and treatment efforts and inform site of results
• Formative Evaluation: Quant. and qual. determination of impact
• Establish a Learning Collaborative: Shared learning opportunities tailored to stakeholders
• Program Marketing: Increase attention to availability of on-site addiction treatment services

Interventions

Implementation Facilitation

Implementation Facilitation is an evidence-based strategy tailored to the specific needs of the clinic, designed to increase uptake of evidence based treatments for tobacco, alcohol and opioid use disorders. Will include provider education and academic detailing.

• External Facilitator: Outside content expert who assists site
• Local Champion: Site stakeholder who promotes change
• Provider Education and Academic Detailing: Provision of unbiased peer education
• Stakeholder Engagement: Aligning goals of implementation and those impacted
• Tailor Program to Site: Addressing site specific needs based on Aim 1
• Performance Monitoring and Feedback: Assess implementation of screening and treatment efforts and inform site of results
• Formative Evaluation: Quant. and qual. determination of impact
• Establish a Learning Collaborative: Shared learning opportunities tailored to stakeholders
• Program Marketing: Increase attention to availability of on-site addiction treatment services

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Fiellin, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Jennifer Edelmen, MD

Role: STUDY_DIRECTOR

Yale University

Locations

Hartford Hospital's HIV Clinic

Hartford, Connecticut, United States

Haelen Center at Yale New Haven Hospital

New Haven, Connecticut, United States

SUNY Downstate Medical Center

Brooklyn, New York, United States

Immunology Center at Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

References

Edelman EJ, Dziura J, Esserman D, Porter E, Becker WC, Chan PA, Cornman DH, Rebick G, Yager J, Morford K, Muvvala SB, Fiellin DA. Working with HIV clinics to adopt addiction treatment using implementation facilitation (WHAT-IF?): Rationale and design for a hybrid type 3 effectiveness-implementation study. Contemp Clin Trials. 2020 Nov;98:106156. doi: 10.1016/j.cct.2020.106156. Epub 2020 Sep 23.

Reference Type: BACKGROUND

PMID: 32976995 (View on PubMed)

Edelman EJ, Gan G, Dziura J, Esserman D, Morford KL, Porter E, Chan PA, Cornman DH, Oldfield BJ, Yager JE, Muvvala SB, Fiellin DA. Readiness to Provide Medications for Addiction Treatment in HIV Clinics: A Multisite Mixed-Methods Formative Evaluation. J Acquir Immune Defic Syndr. 2021 Jul 1;87(3):959-970. doi: 10.1097/QAI.0000000000002666.

Reference Type: RESULT

PMID: 33675619 (View on PubMed)

Morford KL, Muvvala SB, Chan PA, Cornman DH, Doernberg M, Porter E, Virata M, Yager JE, Fiellin DA, Edelman EJ. Patients' perspectives of medications for addiction treatment in HIV clinics: A qualitative study. J Subst Abuse Treat. 2022 Aug;139:108767. doi: 10.1016/j.jsat.2022.108767. Epub 2022 Mar 18.

Reference Type: RESULT

PMID: 35341613 (View on PubMed)

Edelman EJ, Gan G, Dziura J, Esserman D, Porter E, Becker WC, Chan PA, Cornman DH, Helfrich CD, Reynolds J, Yager JE, Morford KL, Muvvala SB, Fiellin DA. Effect of Implementation Facilitation to Promote Adoption of Medications for Addiction Treatment in US HIV Clinics: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2236904. doi: 10.1001/jamanetworkopen.2022.36904.

Reference Type: RESULT

PMID: 36251291 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DA041067

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HIC1509016500

Identifier Type: -

Identifier Source: org_study_id