Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Los Angeles General Medical Center | OTHER |
| AIDS Healthcare Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| smART | Experimental | smART (Smart Antiretroviral Therapy Assistant): a digital clinical decision support tool that provides personalized, guideline-based HIV treatment recommendations. |
|
| Traditional Prescribing resources | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at completion of each patient prescribing session at Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of virally suppressed individuals | Viral suppression rates | Assessed at between 1 month and 6 month after completion of each prescribing session |
Not provided
Inclusion Criteria:
HIV patients
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hayoun Lee, PhD | Contact | 626-318-4471 | hayoun@usc.edu | |
| Christian Takayama, MD | Contact | ctakayama@dhs.lacounty.gov |
| Name | Affiliation | Role |
|---|---|---|
| Hayoun Lee, PhD | Keck School of Medicine of USC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles General Medical Center | Los Angeles | California | 90033 | United States |
De-identified individual participant data, including drug resistance mutations, comorbidities, comedications, and prescribed regimens, will be shared by publishing manuscripts covering this trial outcomes.
The study protocol will be published as supporting information upon completion of the trial and publication of its results.
Anyone with access to the academic journals publishing this study's results.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Traditional Prescribing resources | 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. |
|
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided