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NCT05241990 · ClinicalTrials.gov registry record · NA

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

A NA study of HIV and Alcohol Use, Unspecified, sponsored by Johns Hopkins University.

Recruiting
Registry status
NA
Development phase
300
Enrollment target
3
Study locations

NCT05241990 is a NA study of HIV and Alcohol Use, Unspecified that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 300 participants, below the 439-participant average among 303 other HIV trials with a reported enrollment target (32% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT05241990, a NA study of HIV and Alcohol Use, Unspecified, is actively recruiting participants, sponsored by Johns Hopkins University.

RECRUITING
Registry status
NA
Development phase
300 participants
Enrollment target
3
Study locations

Study 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 alc

Interventions

  • BEHAVIORAL Practice Facilitation
  • BEHAVIORAL Alcohol Stepped Care

Study Locations (3)

California

  • University of California, San Diego - San Diego

Massachusetts

  • Fenway Community Health - Boston

North Carolina

  • University of North Carolina - Chapel Hill

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2023-02-15
Est. Completion 2026-09-30
Phase NA

Sponsor

Johns Hopkins University

1,448 total trials

What the Registry Record Tells You About NCT05241990

The ClinicalTrials.gov registry entry for NCT05241990 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 439-participant average among 303 other HIV trials with a reported enrollment target (32% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with HIV appearing as the primary indexed condition, and to 2 interventions - of which Practice Facilitation is the first listed.

NCT05241990 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Massachusetts, North Carolina.

Frequently Asked Questions

What is clinical trial NCT05241990 about?

NCT05241990 is a clinical study titled "Practice Facilitation as a Strategy to Improve Alcohol Treatment Adoption and Implementation in HIV Care". 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 fr...

What is the current status of trial NCT05241990?

This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2023-02-15. Estimated completion is 2026-09-30.

What conditions does trial NCT05241990 study?

This clinical trial studies the following conditions: HIV, Alcohol Use, Unspecified.

What interventions are being tested in trial NCT05241990?

The interventions under investigation include: Practice Facilitation (BEHAVIORAL), Alcohol Stepped Care (BEHAVIORAL).

Who is sponsoring clinical trial NCT05241990?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05241990 being conducted?

This trial has 3 study locations across California, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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