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NCT Number: NCT07219862

Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization

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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Key information

Conditions

HIV (Human Immunodeficiency Virus) AIDS (Acquired Immune Deficiency Syndrome) Acquired Immunodeficiency Syndrome Antiretroviral Therapy, Highly Active Blood-Borne Infections Clinical Decision Support System (CDSS) Communicable Diseases Genital Diseases HIV Infections INDIVIDUALIZED THERAPY Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Personalized Medicine Precision Medicine RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

HIV patients:

  • Refusal or inability to give informed consent

Providers:

  • Refusal to give informed consent

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of virally suppressed individuals

    Time frame: Assessed at between 1 month and 6 month after completion of each prescribing session

    Viral suppression rates

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Takayama, MD

CONTACT

[email protected]

Hayoun Lee, PhD

CONTACT

[email protected]

626-318-4471

Sponsors and collaborators

Lead sponsor

Keck School of Medicine of USC

Other

Collaborators

  • AIDS Healthcare Foundation
  • Los Angeles General Medical Center

Registry information

Important dates

Study start
2028
Primary completion
2030
Study completion
2031
First posted
Oct 22, 2025
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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