RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-15
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05241990

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18 years old
  2. * Confirmed to be clinic staff (clinical or administrative roles).
  3. * English speaking
  4. * Cognitively able to complete required survey or interview activities.
  5. * Unable to speak English
  6. * Confirmed to be a person with HIV (PWH) receiving HIV care and participating in CNICS at one of the three clinic sites
  7. * Scoring AUDIT-C ≥3 for women or ≥4 for men, transgender women or men indicating unhealthy alcohol use.
  8. * Age ≥ 18 years old.
  9. * English speaking.
  10. * Cognitively able to participate in stepped care for unhealthy alcohol use.
  11. * Scoring AUDIT-C \<3 for women or \<4 for men or \<4 for transgender women or men
  12. * Age \< 18 years old
  13. * Participants cognitively unable to participate in the stepped care for unhealthy alcohol use.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

JoAnna Mathena
CONTACT
410-955-9534
jmathen5@jhmi.edu
Geetanjali Chander
CONTACT
14432872030
gchande1@jhmi.edu

Principal Investigator

Geetanjali Chander, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

University of California, San Diego
San Diego, California, 92103
United States
Fenway Community Health
Boston, Massachusetts, 02114
United States
University of North Carolina
Chapel Hill, North Carolina, 27599-7215
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Geetanjali Chander, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-15
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2023-02-15
Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Hiv
  • Alcohol Use, Unspecified