Recruiting

Practice Facilitation

Sponsor:

Johns Hopkins University

Code:

NCT05241990

Conditions

Hiv

Alcohol Use, Unspecified

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Practice Facilitation

Alcohol Stepped Care

Study Details

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.

Conditions

Hiv

Alcohol Use, Unspecified

Study ID

NCT05241990

Start date

Feb 15, 2023

Status verified date

Jun, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jun 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

Interventions

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

Primary outcome measure

  • Implementation as assessed by the percent of patients receiving an alcohol intervention [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92103

Contacts

Edward C Cachay

6195433995

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-26.