HIV/HBV/HCV Triple Screening in Primary Care

NCT07031219 | Not Yet Recruiting

• 2 other identifiers: STU20240019IN-US-973-7442
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HIV; HCV; HBV (Hepatitis B Virus)

Keywords

screening; provider orders; quality improvement

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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)

  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

  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

  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

  24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)

Study Arms (1)

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.

Other: electronic medical record alert linked to orders

Interventions

electronic medical record alert linked to orders OTHER

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.

Randomized encounters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Gilead Sciences: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Mamta K Jain, MD, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole E Naiman, MD/PhD

CONTACT

214-645-9317; nicole.naiman@utsouthwestern.edu

Stephanie Reyes

CONTACT

214-645-9317; Stephanie.Reyes@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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".

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)