What this study is
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.
What's being tested
- smART (Smart Antiretroviral Therapy Assistant)
Intervention · OTHER
smART 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
Intervention · OTHER
No 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.
Study details
- Sponsor
- Keck School of Medicine of USC
- Conditions
- HIV (Human Immunodeficiency Virus) · Clinical Decision Support System (CDSS) · Antiretroviral Therapy, Highly Active · INDIVIDUALIZED THERAPY · AIDS (Acquired Immune Deficiency Syndrome) · Personalized Medicine · Precision Medicine
- Enrolling
- 250 people
- Starts
- 2028-09-01
- Est. completion
- 2031-09-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- HIV patients
- Documented HIV-1 infection
- Greater than 18 years of age
- Genotype resistance testing previously conducted or scheduled through clinical care Providers: HIV care providers who will determine treatment selections, with or without utilizing our clinical decision support tool
You can't join if
- Refusal or inability to give informed consent Providers:
- Refusal to give informed consent
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openLos Angeles General Medical Center
Los Angeles, California, United States
Study team
Sponsor
Keck School of Medicine of USC
Study ID AI095066
Principal investigator
Hayoun Lee, PhD
Keck School of Medicine of USC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.