Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKeck School of Medicine of USC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Documented HIV-1 infection

Greater than 18 years of age

Genotype resistance testing previously conducted or scheduled through clinical care

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • smART (Smart Antiretroviral Therapy Assistant)

    Other intervention

    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 intervention

    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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: smARTExperimental treatment 1 intervention
Group B: Traditional Prescribing resourcesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adherence of Prescribed ART Regimens to Evidence-Based Recommendations

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.

Time frame
Assessed at completion of each patient prescribing session at Day 1

Secondary outcomes

1

Proportion of virally suppressed individuals

Viral suppression rates

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Keck School of Medicine of USC

Lead sponsor

Los Angeles General Medical Center

Collaborator

AIDS Healthcare Foundation

Collaborator

This trial is not recruiting at the moment. You can still explore other options: