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NCT Number: NCT05241990

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinic Staff

  • Age > 18 years old
  • Confirmed to be clinic staff (clinical or administrative roles).
  • English speaking
  • Cognitively able to complete required survey or interview activities.

Exclusion criteria

Clinic Staff

  • Unable to speak English

Inclusion criteria

, Patients

  • 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.

Exclusion criteria

, Patients

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Implementation as assessed by the percent of patients receiving an alcohol intervention

    Time frame: 12 months

    Percent of patients receiving an alcohol intervention since their last visit among all eligible individuals.

Secondary outcomes

  1. Change in unhealthy alcohol use as assessed by the Alcohol Use Disorder Identification test-Consumption (AUDIT-C)

    Time frame: Baseline and 12 months

    AUDIT-C Score of <3 in women and <4 in men indicating reduction to lower risk use

  2. Antiretroviral therapy adherence as assessed by a self report on a visual analog scale

    Time frame: 12 months

    Self report of >90% adherence on visual analog scale with higher scores indicating greater adherence

  3. Viral Suppression as assessed by HIV-RNA copies

    Time frame: 12 months

    Viral Suppression will assessed by HIV-RNA copies. HIV-RNA <200 copies indicates viral suppression.

Study contacts

Contact information is provided by the study sponsor or research team.

Geetanjali Chander

CONTACT

[email protected]

14432872030

JoAnna Mathena

CONTACT

[email protected]

410-955-9534

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Fenway Community Health
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • University of Alabama at Birmingham
  • University of California, San Diego
  • University of North Carolina
  • University of Washington

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 16, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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