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
2 other identifiers
interventional
300
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started Feb 2023
Typical duration for not_applicable hiv
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2022
CompletedFirst Posted
Study publicly available on registry
February 16, 2022
CompletedStudy Start
First participant enrolled
February 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
July 20, 2025
July 1, 2025
3.3 years
February 7, 2022
July 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in unhealthy alcohol use as assessed by the Alcohol Use Disorder Identification test-Consumption (AUDIT-C)
Baseline and 12 months
Antiretroviral therapy adherence as assessed by a self report on a visual analog scale
12 months
Viral Suppression as assessed by HIV-RNA copies
12 months
Study Arms (1)
Alcohol Stepped Care
EXPERIMENTALBased 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
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Age \> 18 years old
- Confirmed to be clinic staff (clinical or administrative roles).
- English speaking
- Cognitively able to complete required survey or interview activities.
You may not qualify if:
- Unable to speak English
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)collaborator
- University of Washingtoncollaborator
- University of Alabama at Birminghamcollaborator
- Fenway Community Healthcollaborator
- University of North Carolinacollaborator
- University of California, San Diegocollaborator
Study Sites (3)
University of California, San Diego
San Diego, California, 92103, United States
Fenway Community Health
Boston, Massachusetts, 02114, United States
University of North Carolina
Chapel Hill, North Carolina, 27599-7215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geetanjali Chander, MD
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Betsy McCaul, PhD
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2022
First Posted
February 16, 2022
Study Start
February 15, 2023
Primary Completion (Estimated)
June 15, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
July 20, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 12 months after study completion
- Access Criteria
- https://nda.nih.gov/niaaa
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)