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

Official title

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

Overview

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.

Interventions

• Behavioral 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.
• Behavioral Alcohol Stepped Care
  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

Primary outcome measures

• Implementation as assessed by the percent of patients receiving an alcohol intervention [Time frame: 12 months]

Secondary outcome measures (3)

• Change in unhealthy alcohol use as assessed by the Alcohol Use Disorder Identification test-Consumption (AUDIT-C) [Time frame: Baseline and 12 months]
• Antiretroviral therapy adherence as assessed by a self report on a visual analog scale [Time frame: 12 months]
• Viral Suppression as assessed by HIV-RNA copies [Time frame: 12 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 3 centers

• University of California, San Diego — San Diego
• Fenway Community Health — Boston
• University of North Carolina — Chapel Hill

Publications

• Chander G, Batey DS, Austin EJ, Bentley MJ, Cachay ER, Crane HM, Farel C, Fleming J, Grelotti DJ, Hutton HE, Idrisov B, Mathena J, McCaul ME, Napravnik S, O'Clerigh C, Lau B, Williams EC. Practice facilitation to implement stepped care for unhealthy alcohol use in HIV clinics: study protocol for a type III hybrid effectiveness-implementation study. Addict Sci Clin Pract. 2026 Mar 31;21(1):34. doi: PMID 41918133

Identifiers

NCT: NCT05241990 · IRB00303116 · P01AA029544

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗