Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Adherence of Prescribed ART Regimens to Evidence-Based Recommendations
Study Overview
Brief Summary
This study is testing software designed to help healthcare providers choose the best HIV treatment combinations for their patients. HIV medicines, known as antiretroviral therapy (ART), can be complex to manage because the right regimen depends on many factors-such as drug resistance, other health conditions, and medication schedules. Many people with HIV are cared for by general clinicians who may not have access to HIV specialists, which can make treatment decisions more challenging.
In this study, healthcare providers will use patient cases to compare standard HIV treatment resources with a new clinical decision support tool that gives evidence-based ART recommendations at the point of care.
The investigators hypothesize that using the tool will help providers select treatment plans that better match clinical guidelines, make decisions faster, reduce mental effort, and increase overall satisfaction with the prescribing process.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •HIV patients
- •Documented HIV-1 infection
- •Greater than 18 years of age
- •Genotype resistance testing previously conducted or scheduled through clinical care
- •HIV care providers who will determine treatment selections, with or without utilizing our clinical decision support tool
Exclusion Criteria
- •HIV patients:
- •1. Refusal or inability to give informed consent
- •1. Refusal to give informed consent
Arms & Interventions
smART
smART (Smart Antiretroviral Therapy Assistant): a digital clinical decision support tool that provides personalized, guideline-based HIV treatment recommendations.
Intervention: smART (Smart Antiretroviral Therapy Assistant) (Other)
Traditional Prescribing resources
standard online resources commonly accessed in HIV care, including the Stanford HIV Database, the IAS-USA Drug Resistance Mutations Chart, and the NIH HIV Clinical Guidelines.
Intervention: Traditional Prescribing resources (Other)
Outcomes
Primary Outcomes
Adherence of Prescribed ART Regimens to Evidence-Based Recommendations
Time Frame: Assessed at completion of each patient prescribing session at Day 1
Proportion of antiretroviral therapy (ART) regimens that align with guideline-based recommendations. A regimen is considered adherent if it contains at least three fully active agents (defined as a total drug susceptibility score ≥280) and is not contraindicated based on patient-specific factors identified by the smART tool, including allergies, comorbidities, concomitant medications, pregnancy status, and/or major guideline restrictions.
Secondary Outcomes
- Proportion of virally suppressed individuals(Assessed at between 1 month and 6 month after completion of each prescribing session)
Investigators
Hayoun Lee
Associate Professor
Keck School of Medicine of USC