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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05241990
• Other study ID #: IRB00303116
• Secondary ID: P01AA029544
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: September 2026

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: JoAnna Mathena
• Phone: 410-955-9534
• Email: jmathen5[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use, Unspecified
• Hiv

Intervention

Behavioral:
• 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.
• 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

Locations

Country	Name	City	State
United States	Fenway Community Health	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of California, San Diego	San Diego	California

Sponsors (7)

Lead Sponsor	Collaborator
Johns Hopkins University	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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	Baseline and 12 months
Secondary	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	12 months
Secondary	Viral Suppression as assessed by HIV-RNA copies	Viral Suppression will assessed by HIV-RNA copies. HIV-RNA <200 copies indicates viral suppression.	12 months