Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV Care

Johns Hopkins University

Status: Enrolling

Conditions: Alcohol Use, Unspecified; Hiv

Treatments: Behavioral: Alcohol Stepped Care; Behavioral: Practice Facilitation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05241990

IRB00303116

P01AA029544 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Despite availability of evidence-based alcohol reduction interventions (EBI), unhealthy alcohol use remains a barrier to HIV medication adherence, viral suppression and retention in HIV care and consequently HIV treatment as prevention (TASP). Guided by complementary implementation and evaluation frameworks-the Consolidated Framework for Implementation Research (CFIR) and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance), The investigators will conduct a Hybrid Type 3 effectiveness-implementation evaluating implementation trial testing whether practice facilitation, an evidence-based multifaceted implementation strategy increases reach, adoption, implementation, and maintenance of stepped care for unhealthy alcohol use in three Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) HIV clinics located in Boston, San Diego, and Chapel Hill. The investigators will secondarily test whether practice facilitation is associated with decreased unhealthy alcohol use, and improved Antiretroviral Therapy (ART) adherence and viral suppression at the patient level. In practice facilitation, a practice coach will offer tools, resources, hands-on guidance, and content expertise to assist sites in offering a stepped care model of alcohol treatment to patients with unhealthy alcohol use. Stepped care will include brief intervention, cognitive behavioral therapy, and alcohol pharmacotherapy. The practice facilitation intervention will be rolled out sequentially across sites. There will be three phases at each site: pre-implementation planning, implementation with formative evaluation, and post-implementation summative evaluation. Using mixed methods, The investigators specifically propose to meet the following specific aims: (Aim 1) Tailor the practice facilitation intervention to each site using mixed methods (pre-implementation); (Aim 2a) Determine the effects of practice facilitation on implementation of stepped care (primary) and alcohol use and HIV-related outcomes (secondary) using interrupted time series analysis with synthetic controls (summative evaluation); (Aim 2b) Determine the effect of practice facilitation on reach, adoption, and maintenance of evidence-based alcohol treatment using mixed methods (formative evaluation); and (Aim 3) Describe barriers and facilitators to implementation of alcohol-related interventions at each site to describe maintenance and inform widespread sustainable implementation.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Clinic Staff

• Age > 18 years old
• Confirmed to be clinic staff (clinical or administrative roles).
• English speaking
• Cognitively able to complete required survey or interview activities.

Exclusion Criteria Clinic Staff

• Unable to speak English

Inclusion Criteria, Patients

• Confirmed to be a person with HIV (PWH) receiving HIV care and participating in CNICS at one of the three clinic sites
• Scoring AUDIT-C ≥3 for women or ≥4 for men, transgender women or men indicating unhealthy alcohol use.
• Age ≥ 18 years old.
• English speaking.
• Cognitively able to participate in stepped care for unhealthy alcohol use.

Exclusion Criteria, Patients

• Scoring AUDIT-C <3 for women or <4 for men or <4 for transgender women or men
• Age < 18 years old
• Participants cognitively unable to participate in the stepped care for unhealthy alcohol use.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Alcohol Stepped Care

Experimental group

Description:

Based on severity of alcohol use, individuals receive brief alcohol intervention delivered in person or by computer, cognitive behavioral therapy by person or computer, or pharmacotherapy for alcohol use disorder

Treatment:

Behavioral: Practice Facilitation

Behavioral: Alcohol Stepped Care