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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age > 18 years old

Confirmed to be clinic staff (clinical or administrative roles).

English speaking

Cognitively able to complete required survey or interview activities.

Disqualifiers

Unable to speak English

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Alcohol Stepped CareExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
12 months

Secondary outcomes

1

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

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

Time frame
Baseline and 12 months
2

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

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

Time frame
12 months
3

Viral Suppression as assessed by HIV-RNA copies

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

Time frame
12 months

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

University of Washington

Collaborator

University of Alabama at Birmingham

Collaborator

Fenway Community Health

Collaborator

University of North Carolina

Collaborator

University of California, San Diego

Collaborator