Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05241990

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

Led by Johns Hopkins University · Updated on 2025-07-20

300

Participants Needed

3

Research Sites

189 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinic staff aged over 18 years
  • Clinic staff in clinical or administrative roles
  • Clinic staff who speak English
  • Clinic staff cognitively able to complete surveys or interviews
  • People with HIV receiving care at one of the three clinic sites
  • People with HIV scoring AUDIT-C 3 or higher for women, or 4 or higher for men or transgender individuals indicating unhealthy alcohol use
  • People with HIV aged 18 years or older
  • People with HIV who speak English
  • People with HIV cognitively able to participate in stepped care for unhealthy alcohol use
Not Eligible

You will not qualify if you...

  • Clinic staff unable to speak English
  • People with HIV scoring AUDIT-C less than 3 for women, or less than 4 for men or transgender individuals
  • People with HIV younger than 18 years old
  • People with HIV cognitively unable to participate in stepped care for unhealthy alcohol use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University of California, San Diego

San Diego, California, United States, 92103

Actively Recruiting

2

Fenway Community Health

Boston, Massachusetts, United States, 02114

Not Yet Recruiting

3

University of North Carolina

Chapel Hill, North Carolina, United States, 27599-7215

Not Yet Recruiting

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Research Team

J

JoAnna Mathena

CONTACT

G

Geetanjali Chander

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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