NCT07219862

Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Keck School of Medicine of USC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
OTHER	smART (Smart Antiretroviral Therapy Assistant)	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.
OTHER	Traditional Prescribing resources	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.

Timeline

• Start date: 2028-09-01
• Primary completion: 2030-09-01
• Completion: 2031-09-01
• First posted: 2025-10-22
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States