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
Among 197 studies in Hepatitis B with a site in United States — 15 open to participants now, 27 under way, 3 of them phase 3. Hepatitis B · United States.
Among the 197 studies in Hepatitis B with a site in United States, this one is the 91st largest by planned enrollment of the 148 interventional ones that give a count, is one of 4 that started in 2026, is one of 20 with no phase, reaches primary completion later than 16 of the 25 other live ones, and was the 193rd registered.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
Browse Hepatitis B studies →15 of the 197 studies in Hepatitis B with a site in United States are open now. Recruiting first, the newest first:
AusperBio Therapeutics Inc. · Sites in United States, Canada, France and 3 more countries
West Virginia University · Sites in United States
University of Maryland, Baltimore · Sites in United States
GigaGen, Inc. · Sites in United States, Australia, Hong Kong and 2 more countries
University of Maryland, Baltimore · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 79 Hepatitis B studies recruiting now, 40 (51%) set no upper age limit and 34 (43%) stop at 75 or younger; 13 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
197 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 34 · Phase 2 52 · Phase 3 33 · Phase 4 20
First in 1989; this study’s year is marked. 4 started in 2026.
This study's planned enrollment of 50 is below the median of 147 across 756 interventional studies indexed under Hepatitis B.
Median enrollment 90 across the 148 interventional studies, 284 across the 44 observational. Of the 157 that completed or were terminated, 62 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
90 of 197 have an industry lead sponsor. The 10 most frequent:
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.
University of Texas Southwestern Medical Center has 2 studies filed under Hepatitis B — fewer than ten, so there is no comparison to draw.
8 of the studies in Hepatitis B with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01796457University of PennsylvaniaHBRN: Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B | 2026-12-01 |
| NCT01298037University of PennsylvaniaHBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B | 2026-12-01 |
| NCT06154278University of Maryland, BaltimoreIntrahepatic and Peripheral Responses to Imdusiran (AB-729) in Chronic Hepatitis B | 2026-12-01 |
| NCT06963710Aligos TherapeuticsA Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME) | 2027-03 |
| NCT06497504GlaxoSmithKlineStudy of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus) | 2027-04-22 |
Among the 197 studies in Hepatitis B with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
Of 62 non-industry interventional studies with no phase under Hepatitis B, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 13 months is below that.
Counting every sponsor, half of 68 studies reached it within 29 months; a quarter within 11 and three quarters within 47.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 29, 2026: start Jun 2026 → Nov 2026, primary completion Jun 2027 → Dec 2027 and completion Jun 2027 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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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University of Texas Southwestern Medical Center →