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NCT05241990Recruiting

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

Source: ClinicalTrials.gov · Last updated 26 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
300 (estimated)
First submitted
7 Feb 2022
Start date
15 Feb 2023
Primary completion date
15 Jun 2027
Lead sponsor
Johns Hopkins University
Diseases
HIV
NCT number
NCT05241990

What you commit to

  • Study type: Interventional
  • Planned participants: 300
  • From 15 Feb 2023 to the primary completion date, 15 Jun 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Age \< 18 years old

Other

  • Unable to speak English
  • Scoring AUDIT-C \<3 for women or \<4 for men or \<4 for transgender women or men
  • Participants cognitively unable to participate in the stepped care for unhealthy alcohol use.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fenway Community Health
Coordinator of this site? Confirm its status
BostonUnited StatesNot yet recruiting
University of North Carolina
Coordinator of this site? Confirm its status
Chapel HillUnited StatesNot yet recruiting
University of California San Diego
Coordinator of this site? Confirm its status
San DiegoUnited StatesRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.