Clinical trial NCT05241990: Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV Care
Official title: A Hybrid Type III Implementation Trial Testing Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Alcohol Use, Unspecified
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: University of Washington
name: University of Alabama at Birmingham
name: Fenway Community Health
name: University of North Carolina
name: University of California, San Diego
First posted: 2022-02-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Implementation as assessed by the percent of patients receiving an alcohol intervention
timeFrame: 12 months
Secondary outcomes:
measure: Change in unhealthy alcohol use as assessed by the Alcohol Use Disorder Identification test-Consumption (AUDIT-C)
timeFrame: Baseline and 12 months
measure: Antiretroviral therapy adherence as assessed by a self report on a visual analog scale
timeFrame: 12 months
measure: Viral Suppression as assessed by HIV-RNA copies
timeFrame: 12 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: Johns Hopkins University
name: Geetanjali Chander, MD
role: PRINCIPAL_INVESTIGATOR
References: