About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Documented HIV-1 infection
Greater than 18 years of age
Genotype resistance testing previously conducted or scheduled through clinical care
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
smART (Smart Antiretroviral Therapy Assistant)
Other interventionsmART is a single-page, offline clinical decision support application that generates personalized HIV treatment recommendations by evaluating over 50,000 possible antiretroviral combinations. The user inputs patient-specific data including genotypic resistance profile, comorbid conditions, drug allergies, concomitant medications, and reproductive status (pregnant or planning pregnancy). smART performs all computations locally and does not store any patient information, ensuring complete data privacy.
Traditional Prescribing resources
Other interventionNo additional interventions beyond standard clinical practice will be implemented for study participants. Treatment decisions will be guided by established HIV resources, including the Stanford HIV Database, the IAS-USA Drug Resistance Mutations Chart, and the NIH HIV Clinical Guidelines.
Treatment groups
Trial outcomes
Primary outcomes
Adherence of Prescribed ART Regimens to Evidence-Based Recommendations
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
Viral suppression rates
Sponsors and contacts
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Keck School of Medicine of USC
Lead sponsor
Los Angeles General Medical Center
Collaborator
AIDS Healthcare Foundation
Collaborator
This trial is not recruiting at the moment. You can still explore other options: