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Not yet recruiting NCT07219862

Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization

No phase Interventional HIV (Human Immunodeficiency Virus) Clinical Decision Support System (CDSS) Antiretroviral Therapy, Highly Active INDIVIDUALIZED THERAPY

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: smART (Smart Antiretroviral Therapy Assistant), Traditional Prescribing resources.
Who it may be relevant to
Registry conditions: HIV (Human Immunodeficiency Virus), Clinical Decision Support System (CDSS), Antiretroviral Therapy, Highly Active, INDIVIDUALIZED THERAPY. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Other smART (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 pri
  • Other Traditional 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.

Primary outcome measures

  • Adherence of Prescribed ART Regimens to Evidence-Based Recommendations [Time frame: Assessed at completion of each patient prescribing session at Day 1]
Secondary outcome measures (1)
  • Proportion of virally suppressed individuals [Time frame: Assessed at between 1 month and 6 month after completion of each prescribing session]

Eligibility criteria

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:

1\. Refusal or inability to give informed consent

Providers:

1\. Refusal to give informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Los Angeles General Medical Center — Los Angeles

Identifiers

NCT: NCT07219862 · AI095066

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗