Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV Care
Primary Purpose
Hiv, Alcohol Use, Unspecified
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Practice Facilitation
Alcohol Stepped Care
Sponsored by
About this trial
This is an interventional treatment trial for Hiv
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.
Sites / Locations
- University of California, San DiegoRecruiting
- Fenway Community Health
- University of North Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Alcohol Stepped Care
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
Viral Suppression as assessed by HIV-RNA copies
Viral Suppression will assessed by HIV-RNA copies. HIV-RNA <200 copies indicates viral suppression.
Full Information
NCT ID
NCT05241990
First Posted
February 7, 2022
Last Updated
March 16, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Washington, University of Alabama at Birmingham, Fenway Community Health, University of North Carolina, University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT05241990
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Washington, University of Alabama at Birmingham, Fenway Community Health, University of North Carolina, University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv, Alcohol Use, Unspecified
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alcohol Stepped Care
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Practice Facilitation
Intervention Description
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
Intervention Name(s)
Alcohol Stepped Care
Intervention Description
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 Outcome Measure Information:
Title
Implementation as assessed by the percent of patients receiving an alcohol intervention
Description
Percent of patients receiving an alcohol intervention since their last visit among all eligible individuals.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in unhealthy alcohol use as assessed by the Alcohol Use Disorder Identification test-Consumption (AUDIT-C)
Description
AUDIT-C Score of <3 in women and <4 in men indicating reduction to lower risk use
Time Frame
Baseline and 12 months
Title
Antiretroviral therapy adherence as assessed by a self report on a visual analog scale
Description
Self report of >90% adherence on visual analog scale with higher scores indicating greater adherence
Time Frame
12 months
Title
Viral Suppression as assessed by HIV-RNA copies
Description
Viral Suppression will assessed by HIV-RNA copies. HIV-RNA <200 copies indicates viral suppression.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JoAnna Mathena
Phone
410-955-9534
Email
jmathen5@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Geetanjali Chander
Phone
14432872030
Email
gchande1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geetanjali Chander, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivian Maldonado
Phone
619-543-3995
Email
vmaldonado@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Edward C Cachay
Phone
6195433995
Facility Name
Fenway Community Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Hinchey
Phone
617-643-0385
Email
jhinchey@fenwayhealth.org
First Name & Middle Initial & Last Name & Degree
Conall O'Cleirigh
Phone
617-643-0385
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Napravnik
Phone
919-966-3875
Email
sonia_napravnik@med.unc.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Per NIAAA policy, data will be deposited in the NIAAA Data Archive (NIAAADA), a data repository in the National Institute of Mental Health (NIMH) Data Archive (NDA)
IPD Sharing Time Frame
12 months after study completion
IPD Sharing Access Criteria
https://nda.nih.gov/niaaa
IPD Sharing URL
https://nda.nih.gov/niaaa
Learn more about this trial
Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV Care
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