Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization

NCT07219862 — Not applicable, Not yet recruiting, 250 participants, Keck School of Medicine of USC

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Registry	NCT07219862
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, health services research
Enrollment	250 (Estimated)
Sponsor	Keck School of Medicine of USC (Other); collaborators: Los Angeles General Medical Center, AIDS Healthcare Foundation
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	smART (Smart Antiretroviral Therapy Assistant), Traditional Prescribing resources (Other)
Dates	start 2028-09-01 (estimated), primary completion 2030-09-01 (estimated), completion 2031-09-01 (estimated), first posted 2025-10-22, last updated 2025-10-22
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
smART	Experimental	Other: smART (Smart Antiretroviral Therapy Assistant)	smART (Smart Antiretroviral Therapy Assistant): a digital clinical decision support tool that provides personalized, guideline-based HIV treatment recommendations.
Traditional Prescribing resources	Active comparator	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.

smART (Smart Antiretroviral Therapy Assistant) (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 (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.

+Outcome measures

Primary outcomes

Adherence of Prescribed ART Regimens to Evidence-Based Recommendations [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]: Viral suppression rates

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

HIV patients

1. Documented HIV-1 infection
2. Greater than 18 years of age
3. 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

Exclusion Criteria:

HIV patients:

1\. Refusal or inability to give informed consent

Providers:

1\. Refusal to give informed consent

+Locations (1)

Facility	City	Country	Status
Los Angeles General Medical Center	Los Angeles, California	United States

+Investigators

Hayoun Lee, PhD, Principal investigator, Keck School of Medicine of USC