AIDS (Acquired Immune Deficiency Syndrome), Antiretroviral Therapy, Highly Active, Clinical Decision Support System (CDSS), HIV (Human Immunodeficiency Virus), INDIVIDUALIZED THERAPY, Personalized Medicine, Precision Medicine
Conditions
Keywords
hiv, clinical decision support system, antiretroviral therapy, aids, personalized medicine, precision medicine
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.
Interventions
OTHERsmART (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.
OTHERTraditional 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.
Sponsors
Los Angeles General Medical Center
AIDS Healthcare Foundation
Keck School of Medicine of USC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence of Prescribed ART Regimens to Evidence-Based Recommendations | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of virally suppressed individuals | Assessed at between 1 month and 6 month after completion of each prescribing session | Viral suppression rates |
Countries
United States
Contacts
Primary ContactHayoun Lee, PhD
Backup ContactChristian Takayama, MD
Outcome results
None listed