Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization
1 other identifier
interventional
250
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2028
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2025
CompletedFirst Posted
Study publicly available on registry
October 22, 2025
CompletedStudy Start
First participant enrolled
September 1, 2028
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2030
Study Completion
Last participant's last visit for all outcomes
September 1, 2031
October 22, 2025
October 1, 2025
2 years
October 17, 2025
October 20, 2025
Conditions
Keywords
Outcome Measures
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.
Assessed at completion of each patient prescribing session at Day 1
Secondary Outcomes (1)
Proportion of virally suppressed individuals
Assessed at between 1 month and 6 month after completion of each prescribing session
Study Arms (2)
smART
EXPERIMENTALsmART (Smart Antiretroviral Therapy Assistant): a digital clinical decision support tool that provides personalized, guideline-based HIV treatment recommendations.
Traditional Prescribing resources
ACTIVE COMPARATORstandard 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- HIV patients:
- \. Refusal or inability to give informed consent
- Providers:
- \. Refusal to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Keck School of Medicine of USClead
- Los Angeles General Medical Centercollaborator
- AIDS Healthcare Foundationcollaborator
Study Sites (1)
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hayoun Lee, PhD
Keck School of Medicine of USC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 17, 2025
First Posted
October 22, 2025
Study Start (Estimated)
September 1, 2028
Primary Completion (Estimated)
September 1, 2030
Study Completion (Estimated)
September 1, 2031
Last Updated
October 22, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The study protocol will be published as supporting information upon completion of the trial and publication of its results.
- Access Criteria
- Anyone with access to the academic journals publishing this study's results.
De-identified individual participant data, including drug resistance mutations, comorbidities, comedications, and prescribed regimens, will be shared by publishing manuscripts covering this trial outcomes.