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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: Recruiting NA study of HIV and Alcohol Use, Unspecified, sponsored by Johns Hopkins University.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Percent of patients receiving an alcohol intervention since their last visit among all eligible individuals.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-02-15 |
| Est. Completion | 2026-09-30 |
| Phase | NA |
What NCT05241990 shows while recruiting
NCT05241990 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 439-participant average among 303 other HIV trials with a reported enrollment target (32% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05241990's enrollment target sits among peer trials
300 71st of 303 higher than 231 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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