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

NCT ID: NCT05241990

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hiv Alcohol Use, Unspecified

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Practice Facilitation

Intervention Type 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

Intervention Type 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

Interventions

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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.

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Unable to speak English


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Fenway Community Health

OTHER

Sponsor Role collaborator

University of North Carolina

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geetanjali Chander, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Betsy McCaul, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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University of California, San Diego

San Diego, California, United States

Site Status RECRUITING

Fenway Community Health

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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JoAnna Mathena

Role: CONTACT

410-955-9534

Geetanjali Chander

Role: CONTACT

14432872030

Facility Contacts

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Vivian Maldonado

Role: primary

619-543-3995

Edward C Cachay

Role: backup

6195433995

Justin Hinchey

Role: primary

617-643-0385

Conall O'Cleirigh

Role: backup

617-643-0385

Sonia Napravnik

Role: primary

919-966-3875

Other Identifiers

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P01AA029544

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00303116

Identifier Type: -

Identifier Source: org_study_id

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