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

Part of paid clinical trials in San Diego, California.

Sponsor
Johns Hopkins University
Study ID
NCT05241990
Status
Recruiting

Conditions

  • Alcohol Use, Unspecified
  • Hiv

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Practice Facilitation — BEHAVIORAL
    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.
  • Alcohol Stepped Care — BEHAVIORAL
    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

Study Details

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.

Key Dates

Start date
Feb 15, 2023
Status verified
Jul 2025
Primary completion
Jun 15, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92103
Vivian Maldonado
619-543-3995
Edward C Cachay
6195433995
Fenway Community HealthBostonMassachusetts02114
Justin Hinchey
617-643-0385
Conall O'Cleirigh
617-643-0385
University of North CarolinaChapel HillNorth Carolina27599-7215
Sonia Napravnik
919-966-3875

Find similar trials in San Diego, CA

By condition
By specialty

Related Studies