HIV (Human Immunodeficiency Virus)NCT07219862
Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization
A study testing smART (Smart Antiretroviral Therapy Assistant) and Traditional Prescribing resources in people with HIV (Human Immunodeficiency Virus) and Clinical Decision Support System (CDSS), run by Keck School of Medicine of USC at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV (Human Immunodeficiency Virus), Clinical Decision Support System (CDSS), Antiretroviral Therapy, Highly Active
- What is being tested?
- smART (Smart Antiretroviral Therapy Assistant) and Traditional Prescribing resources
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2028to 1 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- HIV patients:
- 1. Refusal or inability to give informed consent
- Providers:
- 1. Refusal to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christian Takayama, MD contact
United States1 site
Los Angeles General Medical Center
Los Angeles, California, 90033
About this study
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.
- Conditions
- HIV (Human Immunodeficiency Virus), Clinical Decision Support System (CDSS), Antiretroviral Therapy, Highly Active, INDIVIDUALIZED THERAPY, AIDS (Acquired Immune Deficiency Syndrome), Personalized Medicine
- Being tested
- smART (Smart Antiretroviral Therapy Assistant), Traditional Prescribing resources
- Keywords
- hiv, clinical decision support system, antiretroviral therapy, aids, personalized medicine, precision medicine
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| smART | Experimental | smART (Smart Antiretroviral Therapy Assistant): a digital clinical decision support tool that provides personalized, guideline-based HIV treatment recommendations. Receives: Other: smART (Smart Antiretroviral Therapy Assistant) |
| 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. Receives: Other: Traditional Prescribing resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at completion of each patient prescribing session at Day 1
Secondary outcomes (1)
Proportion of virally suppressed individuals
Viral suppression rates
Measured: Assessed at between 1 month and 6 month after completion of each prescribing session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start1 Sep 2028 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keck School of Medicine of USC
- Sponsor type
- University, hospital or other
- Collaborators
- Los Angeles General Medical Center, AIDS Healthcare Foundation
- Responsible party
- Principal investigator, Hayoun Lee, Keck School of Medicine of USC
- Investigators
- Hayoun Lee, PhD, Principal investigator, Keck School of Medicine of USC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219862
- Sponsor's protocol ID
- AI095066
- Status last verified
- Oct 2025
- First submitted
- 17 Oct 2025
- Last updated
- 22 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including drug resistance mutations, comorbidities, comedications, and prescribed regimens, will be shared by publishing manuscripts covering this trial outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization
- ClinicalTrials.gov ID
- NCT07219862
- Acronym / sponsor ID
- AI095066
- Conditions
- HIV (Human Immunodeficiency Virus), Clinical Decision Support System (CDSS), Antiretroviral Therapy, Highly Active, INDIVIDUALIZED THERAPY, AIDS (Acquired Immune Deficiency Syndrome), Personalized Medicine
- Keywords
- hiv, clinical decision support system, antiretroviral therapy, aids, personalized medicine, precision medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Keck School of Medicine of USCUniversity, hospital or other
- Collaborators
- Los Angeles General Medical Center, AIDS Healthcare Foundation
- Study start
- 1 Sep 2028 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 22 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smART | Experimental | Other: smART (Smart Antiretroviral Therapy Assistant)smART (Smart Antiretroviral Therapy Assistant): a digital clinical decision support tool that provides personalized, guideline-based HIV treatment recommendations. |
| Traditional Prescribing resources | Active comparator | Other: Traditional Prescribing resourcesstandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV patients
- Documented HIV-1 infection
- Greater than 18 years of age
- Genotype resistance testing previously conducted or scheduled through clinical care
- HIV care providers who will determine treatment selections, with or without utilizing our clinical decision support tool
Key exclusion criteria (4 listed)
- 1. Refusal or inability to give informed consent
- 1. Refusal to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | smART |
| Traditional Prescribing resourcesNo 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. | Other | Traditional Prescribing resources |
Primary outcome
Adherence of Prescribed ART Regimens to Evidence-Based Recommendations
Time frame: Assessed at completion of each patient prescribing session at Day 1
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.
1 secondary outcome
Proportion of virally suppressed individuals
Time frame: Assessed at between 1 month and 6 month after completion of each prescribing session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including drug resistance mutations, comorbidities, comedications, and prescribed regimens, will be shared by publishing manuscripts covering this trial outcomes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Takayama, MD contact
Hayoun Lee, PhD principal investigator
Keck School of Medicine of USC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smART (Smart Antiretroviral Therapy Assistant) and Traditional Prescribing resources in people with HIV (Human Immunodeficiency Virus) and Clinical Decision Support System (CDSS), run by Keck School of Medicine of USC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayoun Lee, PhD (626-318-4471, hayoun@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence of Prescribed ART Regimens to Evidence-Based Recommendations (time frame: Assessed at completion of each patient prescribing session at Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.