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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hiv; Alcohol Use, Unspecified
• Intervention / Treatment: Behavioral: Practice Facilitation; Behavioral: Alcohol Stepped Care

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JoAnna Mathena; Phone Number: 410-955-9534; Email: jmathen5@jhmi.edu
• Study Contact Backup: Name: Geetanjali Chander; Phone Number: 14432872030; Email: gchande1@jhmi.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • Recruiting
      • University of California, San Diego
      • Contact: Vivian Maldonado; Phone Number: 619-543-3995; Email: vmaldonado@ucsd.edu
      • Contact: Edward C Cachay; Phone Number: 6195433995
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Not yet recruiting
      • Fenway Community Health
      • Contact: Justin Hinchey; Phone Number: 617-643-0385; Email: jhinchey@fenwayhealth.org
      • Contact: Conall O'Cleirigh; Phone Number: 617-643-0385
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7215
      • Not yet recruiting
      • University of North Carolina
      • Contact: Sonia Napravnik; Phone Number: 919-966-3875; Email: sonia_napravnik@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of California, San Diego; University of Alabama at Birmingham; University of Washington; Fenway Community Health; University of North Carolina
• Investigators: Principal Investigator: Geetanjali Chander, MD, Johns Hopkins University; Principal Investigator: Betsy McCaul, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: IRB00303116; P01AA029544 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Per NIAAA policy, data will be deposited in the NIAAA Data Archive (NIAAADA), a data repository in the National Institute of Mental Health (NIMH) Data Archive (NDA)
• IPD Sharing Time Frame: 12 months after study completion
• IPD Sharing Access Criteria: https://nda.nih.gov/niaaa

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No