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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Age \> 18 years old

• Confirmed to be clinic staff (clinical or administrative roles).

• English speaking

• Cognitively able to complete required survey or interview activities.

• 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.

Locations
United States
California
University of California, San Diego
RECRUITING
San Diego
Massachusetts
Fenway Community Health
NOT_YET_RECRUITING
Boston
North Carolina
University of North Carolina
NOT_YET_RECRUITING
Chapel Hill
Contact Information
Primary
JoAnna Mathena
jmathen5@jhmi.edu
410-955-9534
Backup
Geetanjali Chander
gchande1@jhmi.edu
14432872030
Time Frame
Start Date: 2023-02-15
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 300
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: University of Washington, University of North Carolina, University of California, San Diego, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Fenway Community Health, University of Alabama at Birmingham
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov