Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2028-09-01

Study Completion Date

2031-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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smART

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

Group Type EXPERIMENTAL

smART (Smart Antiretroviral Therapy Assistant)

Intervention Type 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 resources

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.

Group Type ACTIVE_COMPARATOR

Traditional Prescribing resources

Intervention Type OTHER

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.

Interventions

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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 privacy.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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