HIV/HBV/HCV Triple Screening in Primary Care

NCT ID: NCT07031219

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-15
• Study Completion Date: 2027-06-30

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; HBV (Hepatitis B Virus); HCV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Randomized encounters

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.

Group Type: OTHER

electronic medical record alert linked to orders

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mamta K. Jain, MD,MPH

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mamta K Jain, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Central Contacts

Nicole E Naiman, MD/PhD

Role: CONTACT

nicole.naiman@utsouthwestern.edu

214-645-9317

Stephanie Reyes

Role: CONTACT

Stephanie.Reyes@UTSouthwestern.edu

214-645-9317

Facility Contacts

Nicole E Naiman, MD/PhD

Role: primary

nicole.naiman@utsouthwestern.edu

2146459317

Stephanie Reyes

Role: backup

Stephanie.Reyes@UTSouthwestern.edu

214-645-9317

Other Identifiers

IN-US-973-7442

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STU20240019

Identifier Type: -

Identifier Source: org_study_id