NCT07031219 · University of Texas Southwestern Medical Center
HIV/HBV/HCV Triple Screening in Primary Care
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Dallas, Texas
Collaborators
Gilead Sciences
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 29, 2026 · Source of record for eligibility and locations