Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization

Keck School of Medicine of USC

Status: Begins enrollment in a year or more

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

Treatments: Other: Traditional Prescribing resources; Other: smART (Smart Antiretroviral Therapy Assistant)

Study type: Interventional

Funder types: Other

Identifiers

NCT07219862

AI095066

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

smART

Experimental group

Description:

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

Treatment:

Other: smART (Smart Antiretroviral Therapy Assistant)

Traditional Prescribing resources

Active Comparator group

Description:

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.

Treatment:

Other: Traditional Prescribing resources