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

Study Overview
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Brief Summary
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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.

Official Title
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A Hybrid Type III Implementation Trial Testing Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV Care

Conditions
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Hiv, Alcohol Use, Unspecified

Intervention / Treatment
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* Behavioral: Practice Facilitation
* Behavioral: Alcohol Stepped Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcohol Stepped Care<br>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 | Behavioral: Practice Facilitation<br>* 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.<br>Behavioral: Alcohol Stepped Care<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation as assessed by the percent of patients receiving an alcohol intervention | Percent of patients receiving an alcohol intervention since their last visit among all eligible individuals. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in unhealthy alcohol use as assessed by the Alcohol Use Disorder Identification test-Consumption (AUDIT-C) | AUDIT-C Score of <3 in women and <4 in men indicating reduction to lower risk use | Baseline and 12 months | 
| Antiretroviral therapy adherence as assessed by a self report on a visual analog scale | Self report of >90% adherence on visual analog scale with higher scores indicating greater adherence | 12 months | 
| Viral Suppression as assessed by HIV-RNA copies | Viral Suppression will assessed by HIV-RNA copies. HIV-RNA <200 copies indicates viral suppression. | 12 months |