HIVNCT07031219
HIV/HBV/HCV Triple Screening in Primary Care
A study testing electronic medical record alert linked to orders in people with HIV and HBV (Hepatitis B Virus), run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Design: This will be a within-subjects repeated-measures design, testing an electronic medical record pop-up alert linked to order panels for screening blood tests for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). Study participants will be primary care providers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, HBV (Hepatitis B Virus), HCV
- What is being tested?
- electronic medical record alert linked to orders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Dec 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient primary care adult providers at participating institutions
- Providers who provide consent to participate in this study.
- Providers must intend to continue their current practice for at least 12 months.
- Providers with at least 12 months experience in their current practice.
Who cannot join
- Providers who do not consent to participate
- Sub-specialty providers
- Pediatric providers
- Providers who anticipate leaving their current practice within the next 12 months (i.e. providers who plan to retire, move, etc.).
- Providers with less than 12 months experience in their current practice (i.e. new providers or trainees who joined the practice within the last year)
- Note: family medicine and med/peds providers can participate, but only for their adult patients. The intervention alert+order panel and any data collection will be restricted to adult patients ≥ 18 years old.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Nicole E Naiman, MD/PhD, 2146459317, nicole.naiman@utsouthwestern.edu
Stephanie Reyes, 214-645-9317, Stephanie.Reyes@UTSouthwestern.edu
About this study
Official title: Syndemic Triple HIV/HBV/HCV Virus Screening Via EMR Automation at Primary Care Clinics
Design:
This will be a within-subjects repeated-measures design, testing an electronic medical record pop-up alert linked to order panels for screening blood tests for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). Study participants will be primary care providers. For each participating provider, their encounter will be randomized to either control (no alert; no changes to EMR interface) or an alert with triple-testing order panel intervention arm (alert linked to order panel with screening tests for all three bloodborne viruses (BBVs) selected by default; the alert will be triggered when a provider attempts to order a screening test for at least one BBV). The alert linked to triple testing orders will only be triggered if the provider orders a virus BBV screening test based on their normal practice and standard of care for their patient. Providers will see which orders are selected prior to signing (finalizing) them; therefore, this study will be unblinded. To mitigate the effect of unblinding, randomization will occur at the encounter level which will lead to providers experiencing both the control and intervention conditions randomly throughout the duration of the study.
Read more
Outcomes/endpoints:
The investigators will compare incidences of HIV, HBV, and HCV diagnoses between the two encounter conditions, estimate number of cases missed by not triple-testing, estimate laboratory costs per condition, and measure patient encounters per condition.
- Conditions
- HIV, HBV (Hepatitis B Virus), HCV
- Being tested
- electronic medical record alert linked to orders
- Keywords
- screening, provider orders, quality improvement
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic medical record alert linked to ordersOther
An electronic medical record alert linked to triple testing orders will be built specifically for this study. An order for a screening blood test for any of the three bloodborne viruses (BBVs; i.e. HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)) will trigger an electronic medical record alert linked to orders for screening blood tests for all three BBVs to be selected by default. If participants accept the alert, the individual BBV order that triggered the alert will be replaced with the pre-selected screening orders for all three BBVs. If the participants dismiss the alert, the individual BBV screening test order that triggered the alert will be accepted without the addition of screening test orders for the other two BBVs. This alert with linked orders will only be available to participating providers throughout the duration of the study, and will only activate for encounters randomized to "intervention" encounters.
| Study group | Role | What they receive |
|---|---|---|
| Randomized encounters | Other | For participating providers, each of their encounters will be randomized to either control (no alert; no changes to EMR interface; standard of care) or intervention (alert linked to triple testing orders will trigger when the provider attempts to order a screening test for HIV, hepatitis B, or hepatitis C). Since randomization will occur at the encounter level, participating providers will randomly experience control and intervention encounters throughout the duration of the study. Receives: Other: electronic medical record alert linked to orders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bloodborne virus (BBV) screening tests
For total bloodborne virus (BBV) screening tests (HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) combined) and each individual BBV (HIV, HBV, or HCV independently), the investigators will measure the number of screening tests: 1) ordered, 2) performed, 3) with a positive result, 4) with a negative result: overall across all encounters, and compared between control and intervention encounters as well as normalized to the providers' pre-study baseline
Measured: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)
Secondary outcomes (5)
Prevalences of bloodborne viruses (BBVs)
Prevalences of HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) as well as BBV co-infections among patients of participating providers overall across all encounters, and compared between control and intervention encounters as well as normalized to the providers' pre-study baseline
Measured: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)
Incidences of bloodborne viruses (BBVs)
Incidences of HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) as well as BBV co-infections among patients of participating providers overall across all encounters, and compared between control and intervention encounters as well as normalized to the providers' pre-study baseline
Measured: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)
Number of patient encounters required to make a virus diagnosis and link patients to care
Number of patient encounters required to make a virus diagnosis and link patients to care overall across all encounters, and compared between control and intervention encounters as well as normalized to the providers' pre-study baseline
Measured: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)
Cost efficiency analysis
Assess and determine cost efficiency via analysis of laboratory costs by estimating laboratory costs per patient and per new diagnosis overall across all encounters, and compared between control and intervention encounters as well as normalized to the providers' pre-study baseline
Measured: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)
Repeated BBV tests
Measure frequencies of repeated tests before and after excluding those with a known BBV diagnosis prior to the study across all encounters, and compared between control and intervention encounters as well as normalized to the providers' pre-study baseline
Measured: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a within-subjects repeated-measures unblinded design. All providers (participants) will have encounters randomized to control (no alert) or intervention (alert) throughout the duration of the study. Therefore, all providers (participants) are technically assigned to the same "study arm".
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Mamta K. Jain, MD,MPH, University of Texas Southwestern Medical Center
- Investigators
- Mamta K Jain, MD, MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031219
- Sponsor's protocol ID
- STU20240019
- Other IDs
- IN-US-973-7442
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Syndemic Triple HIV/HBV/HCV Virus Screening Via EMR Automation at Primary Care Clinics
- ClinicalTrials.gov ID
- NCT07031219
- Acronym / sponsor ID
- STU20240019
- Conditions
- HIV, HBV (Hepatitis B Virus), HCV
- Keywords
- screening, provider orders, quality improvement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jun 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.
Design:
This will be a within-subjects repeated-measures design, testing an electronic medical record pop-up alert linked to order panels for screening blood tests for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). Study participants will be primary care providers. For each participating provider, their encounter will be randomized to either control (no alert; no changes to EMR interface) or an alert with triple-testing order panel intervention arm (alert linked to order panel with screening tests for all three bloodborne viruses (BBVs) selected by default; the alert will be triggered when a provider attempts to order a screening test for at least one BBV). The alert linked to triple testing orders will only be triggered if the provider orders a virus BBV screening test based on their normal practice and standard of care for their patient. Providers will see which orders are selected prior to signing (finalizing) them; therefore, this study will be unblinded. To mitigate the effect of unblinding, randomization will occur at the encounter level which will lead to providers experiencing both the control and intervention conditions randomly throughout the duration of the study.
Outcomes/endpoints:
The investigators will compare incidences of HIV, HBV, and HCV diagnoses between the two encounter conditions, estimate number of cases missed by not triple-testing, estimate laboratory costs per condition, and measure patient encounters per condition.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a within-subjects repeated-measures unblinded design. All providers (participants) will have encounters randomized to control (no alert) or intervention (alert) throughout the duration of the study. Therefore, all providers (participants) are technically assigned to the same "study arm".
| Arm | Type | Receives |
|---|---|---|
| Randomized encounters | Other | Other: electronic medical record alert linked to ordersFor participating providers, each of their encounters will be randomized to either control (no alert; no changes to EMR interface; standard of care) or intervention (alert linked to triple testing orders will trigger when the provider attempts to order a screening test for HIV, hepatitis B, or hepatitis C). Since randomization will occur at the encounter level, participating providers will randomly experience control and intervention encounters throughout the duration of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatient primary care adult providers at participating institutions
- Providers who provide consent to participate in this study.
- Providers must intend to continue their current practice for at least 12 months.
- Providers with at least 12 months experience in their current practice.
Key exclusion criteria (6 listed)
- Providers who do not consent to participate
- Sub-specialty providers
- Pediatric providers
- Providers who anticipate leaving their current practice within the next 12 months (i.e. providers who plan to retire, move, etc.).
- Providers with less than 12 months experience in their current practice (i.e. new providers or trainees who joined the practice within the last year)
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 |
|---|---|---|
| electronic medical record alert linked to ordersAn electronic medical record alert linked to triple testing orders will be built specifically for this study. An order for a screening blood test for any of the three bloodborne viruses (BBVs; i.e. HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)) will trigger an electronic medical record alert linked to orders for screening blood tests for all three BBVs to be selected by default. If participants accept the alert, the individual BBV order that triggered the alert will be replaced with the pre-selected screening orders for all three BBVs. If the participants dismiss the alert, the individual BBV screening test order that triggered the alert will be accepted without the addition of screening test orders for the other two BBVs. This alert with linked orders will only be available to participating providers throughout the duration of the study, and will only activate for encounters randomized to "intervention" encounters. | Other | Randomized encounters |
Primary outcome
Bloodborne virus (BBV) screening tests
Time frame: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)
For total bloodborne virus (BBV) screening tests (HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) combined) and each individual BBV (HIV, HBV, or HCV independently), the investigators will measure the number of screening tests: 1) ordered, 2) performed, 3) with a positive result, 4) with a negative result: overall across all encounters, and compared between control and intervention encounters as well as normalized to the providers' pre-study baseline
5 secondary outcomes
Prevalences of bloodborne viruses (BBVs)
Time frame: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)
Incidences of bloodborne viruses (BBVs)
Time frame: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)
Number of patient encounters required to make a virus diagnosis and link patients to care
Time frame: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)
Cost efficiency analysis
Time frame: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)
Repeated BBV tests
Time frame: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)
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 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Mamta K Jain, MD, MPH principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic medical record alert linked to orders in people with HIV and HBV (Hepatitis B Virus), run by University of Texas Southwestern Medical Center 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. 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 Nicole E Naiman, MD/PhD (214-645-9317, nicole.naiman@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bloodborne virus (BBV) screening tests (time frame: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)). 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 29 Oct 2026.