An interventional study of electronic medical record alert linked to orders in HIV, HBV (Hepatitis B Virus) and HCV, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Health services research
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.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's planned enrollment of 50 is below the median of 147 across 756 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
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Exclusion Criteria:
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.
Other: electronic medical record alert linked to orders
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.
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
Time frame: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)
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
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)
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
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
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
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
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
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
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
Time frame: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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