Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization

N/ANot Yet RecruitingNCT07219862

Keck School of Medicine of USC250 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

250

Conditions

HIV (Human Immunodeficiency Virus)Clinical Decision Support System (CDSS)Antiretroviral Therapy, Highly Active

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 resourcesOTHER

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

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Assessed at completion of each patient prescribing session at Day 1

Secondary Outcomes

Proportion of virally suppressed individuals

Viral suppression rates

Time frame: Assessed at between 1 month and 6 month after completion of each prescribing session