Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization

October 20, 2025 updated by: Hayoun Lee, Keck School of Medicine of USC

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hayoun Lee, PhD
  • Phone Number: 626-318-4471
  • Email: hayoun@usc.edu

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Los Angeles General Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: smART
smART (Smart Antiretroviral Therapy Assistant): a digital clinical decision support tool that provides personalized, guideline-based HIV treatment recommendations.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at completion of each patient prescribing session at Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of virally suppressed individuals
Time Frame: Assessed at between 1 month and 6 month after completion of each prescribing session
Viral suppression rates
Assessed at between 1 month and 6 month after completion of each prescribing session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keck School of Medicine of USC

Collaborators

AIDS Healthcare Foundation
Los Angeles General Medical Center

Investigators

  • Principal Investigator: Hayoun Lee, PhD, Keck School of Medicine of USC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2028

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

October 17, 2025

First Submitted That Met QC Criteria

October 20, 2025

First Posted (Estimated)

October 22, 2025

Study Record Updates

Last Update Posted (Estimated)

October 22, 2025

Last Update Submitted That Met QC Criteria

October 20, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI095066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data, including drug resistance mutations, comorbidities, comedications, and prescribed regimens, will be shared by publishing manuscripts covering this trial outcomes.

IPD Sharing Time Frame

The study protocol will be published as supporting information upon completion of the trial and publication of its results.

IPD Sharing Access Criteria

Anyone with access to the academic journals publishing this study's results.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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