Clinical trial NCT02907944: Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation
Official title: Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation (WHAT-IF?)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-09-20
Enrollment: 3838
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Provision of Addiction Treatments
timeFrame: Baseline, 6 months
measure: Change in Provision of Addiction Treatments
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Antiretroviral Therapy (ART) Receipt
timeFrame: 6 months
measure: Antiretroviral Therapy (ART) Receipt
timeFrame: 12 months
measure: Viral Suppression
timeFrame: 6 months
measure: Viral Suppression
timeFrame: 12 months
measure: VACS Index
timeFrame: 6 months
measure: VACS Index
timeFrame: 12 months
measure: Retention in HIV Care
timeFrame: 6 months
measure: Retention in HIV Care
timeFrame: 12 months
measure: Organizational Readiness
timeFrame: 6 months
measure: Organizational Readiness
timeFrame: 12 months
measure: Provider Readiness
timeFrame: 6 months
measure: Provider Readiness:
timeFrame: 12 months
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital's HIV Clinic
state: Connecticut
city: New Haven
country: United States
facility: Haelen Center at Yale New Haven Hospital
state: Connecticut
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Providence
country: United States
facility: Immunology Center at Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Yale University
name: David Fiellin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Jennifer Edelmen, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.