Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization

Part of paid clinical trials in Los Angeles, California.

Sponsor
Keck School of Medicine of USC
Study ID
NCT07219862
Status
Not Yet Recruiting

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Conditions

  • AIDS (Acquired Immune Deficiency Syndrome)
  • Antiretroviral Therapy, Highly Active
  • Clinical Decision Support System (CDSS)
  • HIV (Human Immunodeficiency Virus)
  • INDIVIDUALIZED THERAPY
  • Personalized Medicine
  • Precision Medicine

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 1, 2028
Status verified
Oct 2025
Primary completion
Sep 1, 2030
Completion
Sep 1, 2031

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: smART
    smART (Smart Antiretroviral Therapy Assistant): a digital clinical decision support tool that provides personalized, guideline-based HIV treatment recommendations.
  • 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.

Primary Outcome Measure

Adherence of Prescribed ART Regimens to Evidence-Based Recommendations [ Time Frame: Assessed at completion of each patient prescribing session at Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Los Angeles General Medical CenterLos AngelesCalifornia90033-

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By research site
Los Angeles General Medical Center· Los Angeles, CA

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