Hepatitis C Virus (HCV)HepC-EnDNCT07406490
Assessing Performance of a Hepatitis C Emergency Department (HepC-EnD) Screening Tool: IT Integration Process for Electronic Health Record System
An observational study of Hepatitis C Virus (HCV) and Hepatitis C Virus (HCV) Infection, run by University of Florida at 3 sites in United States.
Trial summary
The goal of this observational study is to develop, implement, and evaluate a machine learning algorithm-based Hepatitis C Emergency Department (HepC-EnD) screening tool for use in emergency departments (EDs) to identify patients at high risk of hepatitis C virus (HCV) infection. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C Virus (HCV), Hepatitis C Virus (HCV) Infection, HIV (Human Immunodeficiency Virus)
- What is being tested?
- Physician-Initiated Screening (Conventional Screening), FOCUS (Universal Screening) and HepC-EnD (Targeted Screening)
- How many people
- 6,466 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2026to Jul 2027
- Phase
- Observational
- 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 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients visiting UF Health emergency departments.
Who may be able to join
- 18-79 years of age
Who cannot join
- < 18 years of age
- Medically unstable
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
UF Health Shands Emergency Room / Trauma Center
Gainesville, Florida, 32608
UF Health Jacksonville Emergency Room
Jacksonville, Florida, 32209
UF Health North Emergency Room
Jacksonville, Florida, 32218
About this study
The goal of this observational study is to develop, implement, and evaluate a machine learning algorithm-based Hepatitis C Emergency Department (HepC-EnD) screening tool for use in emergency departments (EDs) to identify patients at high risk of hepatitis C virus (HCV) infection. HepC-EnD will be integrated into the University of Florida Health electronic health record (EHR) system as a best practice alert (BPA) pop-up for ED providers, notifying them of patients at high risk for HCV infection and recommending both HCV and human immunodeficiency virus (HIV) screening. Investigators aim to enhance the screening and diagnosis of individuals who may otherwise remain undiagnosed and untreated.
The implementation outcomes (e.g., usability) and effectiveness outcomes (e.g., HCV screening and diagnosis rates) of HepC-EnD targeted screening will be compared with universal screening (FOCUS) and conventional physician-initiated screening programs in EDs.
Read the detailed description
HCV infection has markedly increased in the United States, primarily resulting from injection drug use associated with the ongoing opioid epidemic. Despite the availability of highly effective direct-acting antiviral therapy, more than half of individuals with chronic HCV remain undiagnosed, leading to significant morbidity and mortality. EDs represent a critical setting for HCV and HIV screening, as they are currently the most common setting for missed diagnostic opportunities. However, universal ED-based screening programs are often costly and unsustainable. Moreover, existing targeted screening programs are limited, and have not been systematically developed or rigorously evaluated in clinical practice. Thus, there is a critical public health need to develop innovative, tailored, effective, and sustainable screening strategies to enhance HCV screening in EDs.
This study will accomplish three specific aims:
- Develop and validate prediction algorithms using machine learning and natural language processing (NLP) to identify patients at high risk of HCV infection
- Develop the HCV screening tool prototype HepC-EnD for implementation in EDs
- Compare the usability, effectiveness, and cost-effectiveness of an automated HepC-EnD prompt for HCV (with HIV) testing versus universal and physician-initiated screening strategies
This study is guided by multiple implementation science frameworks, including the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, Proctor's Implementation Outcomes, and Five Rights, which will greatly increase the tool's utility, sustainability, and generalizability.
The investigators will conduct a quasi-experimental study to compare HepC-EnD to two existing screening strategies across three UF Health EDs over 12 months (6 months pre-implementation and 6 months post-implementation). UF Jacksonville Downtown ED will transition from universal screening (FOCUS) to HepC-EnD. UF Jacksonville North ED will continue FOCUS throughout the study period to serve as a control. UF Gainesville ED will pilot HepC-EnD, as FOCUS has not previously been implemented at that site. The study will evaluate the effectiveness of HepC-EnD's within-site and between-site comparisons.
The investigator's central hypothesis is that the use of HepC-EnD will have lower HCV and HIV screening rates but higher diagnosis rates and will be more cost-effective than universal screening and physician-initiated screening strategies.
- Conditions
- Hepatitis C Virus (HCV), Hepatitis C Virus (HCV) Infection, HIV (Human Immunodeficiency Virus)
- Being tested
- Physician-Initiated Screening (Conventional Screening), FOCUS (Universal Screening), HepC-EnD (Targeted Screening)
- Keywords
- Emergency Department, Hepatitis C, Human Immunodeficiency Virus, Implementation Study, Machine Learning, Screening Algorithm, High-Risk Prediction
- Medical subject headings
- Hepatitis C, Infections, Acquired Immunodeficiency Syndrome, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician-Initiated Screening (Conventional Screening)Other
Also called Standard of Care
Screening for HCV and HIV in patients presenting to the ED occurs when an ED provider initiates screening based on symptoms or clinical judgement. Providers will manually order individual tests in the EHR.
FOCUS (Universal Screening)Other
Also called FOCUS, Universal Screening
During nurse triage, a FOCUS screening question will appear in the EHR and the patient will be asked to opt-in to HCV and HIV testing. For those who consented, if an ED provider enters a phlebotomy order for any reason in the EHR, a BPA will alert the providers to suggest HCV and HIV testing. The provider can decide to "order" or "do not order" for each test individually. Ordered tests automatically trigger the following in the EHR: HCV antibody with reflex to RNA and HIV 1/2 antigen/antibody with reflex to confirmation. For all patients who received positive test result in the ED, standardized linkage-to-care processes will be performed. These procedures are currently implemented in clinical practice.
HepC-EnD (Targeted Screening)Other
Also called HepC-EnD
HepC-EnD will run in real time once integrated into the hospital's Epic EHR system. When the patient comes to the ED waiting room, a risk score generated from HepC-EnD will be available and determine if the patient is at high risk of HCV infection (> cutoff risk score). If the patient is determined to be at high risk, a HepC-EnD screening question will appear in the EHR during nurse triage and the patient will be asked will be asked to opt-in to HCV and HIV testing. For those who consented, a BPA will alert the ED provider to suggest HCV and HIV testing. The provider can decide to "order" or "do not order" for each test individually. Ordered tests automatically trigger the following in the EHR: HCV antibody with reflex to RNA and HIV 1/2 antigen/antibody with reflex to confirmation. For all patients who received positive test result in the ED, standardized linkage-to-care processes will be performed.
| Study group | Role | What they receive |
|---|---|---|
| UF Jacksonville North ED | Patients presenting to UF Jacksonville North ED who opt-in for HCV screening during nurse triage. Receives: Other: FOCUS (Universal Screening) | |
| UF Jacksonville Downtown ED | Patients presenting to UF Jacksonville Downtown ED who opt-in for HCV screening during nurse triage (pre- and post-implementation). Receives: Other: FOCUS (Universal Screening); Other: HepC-EnD (Targeted Screening) | |
| UF Gainesville ED | Patients presenting to UF Gainesville ED (pre-implementation) and patents presenting to UF Gainesville ED who opt-in for HCV during nurse triage (post-implementation). Receives: Other: Physician-Initiated Screening (Conventional Screening); Other: HepC-EnD (Targeted Screening) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of new HCV or HIV diagnoses
Proportion of positive results among performed tests. HCV diagnosis is defined as a positive RNA test result. HIV diagnosis is defined as an acute (i.e., antigen positive but antibody negative) or established (i.e., antibody positive) infection.
Measured: Time Frame: 6 months pre- and post-implementation
Absolute number of new HCV or HIV diagnoses
Absolute number of positive results among performed tests. HCV diagnosis is defined as a positive RNA test result. HIV diagnosis is defined as an acute (i.e., antigen positive but antibody negative) or established (i.e., antibody positive) infection.
Measured: 6 months pre- and post-implementation
Secondary outcomes (4)
Proportion of BPA alerts among individuals presenting to EDs
BPA alert for HepC-End or universal screening
Measured: 6 months pre- and post-implementation
Proportion of HCV and HIV tests performed among BPA alerts
Measured: 6 months pre- and post-implementation
Proportion of patients linked to care among those with positive HCV and HIV diagnoses
Linkage to care will be defined as a patient attending a first medical appointment within 3 months of receiving an HCV or HIV diagnosis.
Measured: 3 months after diagnosis
Composite HCV or HIV Diagnoses
All HCV and HIV diagnoses will be considered separately and will include both new and repeat diagnoses.
Measured: 6 months pre- and post-implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C Virus (HCV)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Haesuk Park, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406490
- Sponsor's protocol ID
- IRB202500471
- Other IDs
- R01DA057886, IRB202600334
- Acronym
- HepC-EnD
- Status last verified
- Oct 2025
- First submitted
- 27 Jan 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jang SC, Lo-Ciganic WH, Hernandez-Con P, Jenjai C, Huang J, Stultz A, Yan S, Wilson DL, Norse A, Guirgis FW, Cook RL, Gage C, Nguyen KA, Hornes P, Wu Y, Nelson DR, Park H. Development and Validation of a Machine Learning-Based Screening Algorithm to Predict High-Risk Hepatitis C Infection. Open Forum Infect Dis. 2025 Aug 15;12(8):ofaf496. doi: 10.1093/ofid/ofaf496. eCollection 2025 Aug.
PubMed 40874186
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Performance of a Hepatitis C Emergency Department (HepC-EnD) Screening Tool: IT Integration Process for Electronic Health Record System
- ClinicalTrials.gov ID
- NCT07406490
- Acronym / sponsor ID
- HepC-EnD / IRB202500471
- Conditions
- Hepatitis C Virus (HCV), Hepatitis C Virus (HCV) Infection, HIV (Human Immunodeficiency Virus)
- Keywords
- Emergency Department, Hepatitis C, Human Immunodeficiency Virus, Implementation Study, Machine Learning, Screening Algorithm, High-Risk Prediction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,466 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 12 Feb 2026 (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.
The goal of this observational study is to develop, implement, and evaluate a machine learning algorithm-based Hepatitis C Emergency Department (HepC-EnD) screening tool for use in emergency departments (EDs) to identify patients at high risk of hepatitis C virus (HCV) infection. HepC-EnD will be integrated into the University of Florida Health electronic health record (EHR) system as a best practice alert (BPA) pop-up for ED providers, notifying them of patients at high risk for HCV infection and recommending both HCV and human immunodeficiency virus (HIV) screening. Investigators aim to enhance the screening and diagnosis of individuals who may otherwise remain undiagnosed and untreated.
The implementation outcomes (e.g., usability) and effectiveness outcomes (e.g., HCV screening and diagnosis rates) of HepC-EnD targeted screening will be compared with universal screening (FOCUS) and conventional physician-initiated screening programs in EDs.
Detailed description
HCV infection has markedly increased in the United States, primarily resulting from injection drug use associated with the ongoing opioid epidemic. Despite the availability of highly effective direct-acting antiviral therapy, more than half of individuals with chronic HCV remain undiagnosed, leading to significant morbidity and mortality. EDs represent a critical setting for HCV and HIV screening, as they are currently the most common setting for missed diagnostic opportunities. However, universal ED-based screening programs are often costly and unsustainable. Moreover, existing targeted screening programs are limited, and have not been systematically developed or rigorously evaluated in clinical practice. Thus, there is a critical public health need to develop innovative, tailored, effective, and sustainable screening strategies to enhance HCV screening in EDs.
This study will accomplish three specific aims:
- Develop and validate prediction algorithms using machine learning and natural language processing (NLP) to identify patients at high risk of HCV infection
- Develop the HCV screening tool prototype HepC-EnD for implementation in EDs
- Compare the usability, effectiveness, and cost-effectiveness of an automated HepC-EnD prompt for HCV (with HIV) testing versus universal and physician-initiated screening strategies
This study is guided by multiple implementation science frameworks, including the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, Proctor's Implementation Outcomes, and Five Rights, which will greatly increase the tool's utility, sustainability, and generalizability.
The investigators will conduct a quasi-experimental study to compare HepC-EnD to two existing screening strategies across three UF Health EDs over 12 months (6 months pre-implementation and 6 months post-implementation). UF Jacksonville Downtown ED will transition from universal screening (FOCUS) to HepC-EnD. UF Jacksonville North ED will continue FOCUS throughout the study period to serve as a control. UF Gainesville ED will pilot HepC-EnD, as FOCUS has not previously been implemented at that site. The study will evaluate the effectiveness of HepC-EnD's within-site and between-site comparisons.
The investigator's central hypothesis is that the use of HepC-EnD will have lower HCV and HIV screening rates but higher diagnosis rates and will be more cost-effective than universal screening and physician-initiated screening strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UF Jacksonville North ED | – | Other: FOCUS (Universal Screening)Patients presenting to UF Jacksonville North ED who opt-in for HCV screening during nurse triage. |
| UF Jacksonville Downtown ED | – | Other: FOCUS (Universal Screening), Other: HepC-EnD (Targeted Screening)Patients presenting to UF Jacksonville Downtown ED who opt-in for HCV screening during nurse triage (pre- and post-implementation). |
| UF Gainesville ED | – | Other: Physician-Initiated Screening (Conventional Screening), Other: HepC-EnD (Targeted Screening)Patients presenting to UF Gainesville ED (pre-implementation) and patents presenting to UF Gainesville ED who opt-in for HCV during nurse triage (post-implementation). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting UF Health emergency departments.
Key inclusion criteria (1 listed)
- 18-79 years of age
Key exclusion criteria (2 listed)
- < 18 years of age
- Medically unstable
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 |
|---|---|---|
| Physician-Initiated Screening (Conventional Screening)Also: Standard of CareScreening for HCV and HIV in patients presenting to the ED occurs when an ED provider initiates screening based on symptoms or clinical judgement. Providers will manually order individual tests in the EHR. | Other | UF Gainesville ED |
| FOCUS (Universal Screening)Also: FOCUS, Universal ScreeningDuring nurse triage, a FOCUS screening question will appear in the EHR and the patient will be asked to opt-in to HCV and HIV testing. For those who consented, if an ED provider enters a phlebotomy order for any reason in the EHR, a BPA will alert the providers to suggest HCV and HIV testing. The provider can decide to "order" or "do not order" for each test individually. Ordered tests automatically trigger the following in the EHR: HCV antibody with reflex to RNA and HIV 1/2 antigen/antibody with reflex to confirmation. For all patients who received positive test result in the ED, standardized linkage-to-care processes will be performed. These procedures are currently implemented in clinical practice. | Other | UF Jacksonville Downtown ED, UF Jacksonville North ED |
| HepC-EnD (Targeted Screening)Also: HepC-EnDHepC-EnD will run in real time once integrated into the hospital's Epic EHR system. When the patient comes to the ED waiting room, a risk score generated from HepC-EnD will be available and determine if the patient is at high risk of HCV infection (> cutoff risk score). If the patient is determined to be at high risk, a HepC-EnD screening question will appear in the EHR during nurse triage and the patient will be asked will be asked to opt-in to HCV and HIV testing. For those who consented, a BPA will alert the ED provider to suggest HCV and HIV testing. The provider can decide to "order" or "do not order" for each test individually. Ordered tests automatically trigger the following in the EHR: HCV antibody with reflex to RNA and HIV 1/2 antigen/antibody with reflex to confirmation. For all patients who received positive test result in the ED, standardized linkage-to-care processes will be performed. | Other | UF Gainesville ED, UF Jacksonville Downtown ED |
Primary outcome
Proportion of new HCV or HIV diagnoses
Time frame: Time Frame: 6 months pre- and post-implementation
Proportion of positive results among performed tests. HCV diagnosis is defined as a positive RNA test result. HIV diagnosis is defined as an acute (i.e., antigen positive but antibody negative) or established (i.e., antibody positive) infection.
Absolute number of new HCV or HIV diagnoses
Time frame: 6 months pre- and post-implementation
Absolute number of positive results among performed tests. HCV diagnosis is defined as a positive RNA test result. HIV diagnosis is defined as an acute (i.e., antigen positive but antibody negative) or established (i.e., antibody positive) infection.
4 secondary outcomes
Proportion of BPA alerts among individuals presenting to EDs
Time frame: 6 months pre- and post-implementation
Proportion of HCV and HIV tests performed among BPA alerts
Time frame: 6 months pre- and post-implementation
Proportion of patients linked to care among those with positive HCV and HIV diagnoses
Time frame: 3 months after diagnosis
Composite HCV or HIV Diagnoses
Time frame: 6 months pre- and post-implementation
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 29 Apr 2026.
- Background: PubMed 40874186Jang SC, Lo-Ciganic WH, Hernandez-Con P, Jenjai C, Huang J, Stultz A, Yan S, Wilson DL, Norse A, Guirgis FW, Cook RL, Gage C, Nguyen KA, Hornes P, Wu Y, Nelson DR, Park H. Development and Validation of a Machine Learning-Based Screening Algorithm to Predict High-Risk Hepatitis C Infection. Open Forum Infect Dis. 2025 Aug 15;12(8):ofaf496. doi: 10.1093/ofid/ofaf496. eCollection 2025 Aug.
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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.
Haesuk Park, PhD principal investigator
University of Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus (HCV) and Hepatitis C Virus (HCV) Infection, run by University of Florida at 3 sites 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 1 inclusion and 2 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Haesuk Park, PhD (352-273-6261, hpark@cop.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of new HCV or HIV diagnoses (time frame: Time Frame: 6 months pre- and post-implementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07406490, which also lists 1 linked publication.
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 29 Apr 2026.