Screening Panels for HIV, Hepatitis B, and Hepatitis C

Overseen By Stephanie Reyes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Sub-specialty, Pediatric, Leaving practice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best way to order blood tests for three viruses: HIV, hepatitis B, and hepatitis C. It compares a new method, the HIV/HBV/HCV Triple Screening, where all three tests are ordered simultaneously, with the traditional method of ordering them separately. The goal is to assess whether the new method detects more cases and proves more cost-effective. Primary care doctors who work with adult patients and plan to remain in their positions for at least a year are well-suited for this trial. As an unphased trial, this study offers a unique opportunity to enhance diagnostic methods for viral infections.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems unlikely, as the study focuses on screening panels for blood tests rather than medication use.

What prior data suggests that this screening panel method is safe for primary care providers?

Research shows that testing for HIV, hepatitis B, and hepatitis C simultaneously is safe for patients. These screenings detect diseases early, which is crucial for effective treatment. The World Health Organization has approved a test for HIV, hepatitis B, and another disease, indicating trust in the safety and usefulness of these combined tests.

No major safety issues have emerged with triple screening. While specific side effects aren't detailed, studies indicate that using combined tests is common and recommended. This suggests that patients generally tolerate the tests well. Overall, evidence supports these tests as a helpful healthcare tool without causing significant problems for those who take them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HIV/HBV/HCV Triple Screening because it simplifies and streamlines the testing process for these three bloodborne viruses. Unlike the standard approach, which often requires separate orders and tests for each virus, this new method bundles the tests together into a single order panel by default. This can lead to more efficient and comprehensive screening, potentially catching infections earlier and improving patient outcomes. By integrating the tests, healthcare providers can ensure that patients are screened for all three viruses at once, reducing the risk of missed diagnoses and enhancing overall care.

What evidence suggests that this trial's screening panels could be effective for detecting HIV, HBV, and HCV?

Research has shown that a combined screening method for HIV, hepatitis B, and hepatitis C is highly effective. One study found that the tests in these panels are highly accurate, with a sensitivity of 98.8% and a specificity of 100%. This means they excel at correctly identifying who has these viruses and who does not. In this trial, participants in the triple testing order panel intervention arm will undergo this combined screening approach, which can help detect cases that might be missed if each test is done separately. This approach is recommended for adults at least once in their lifetime, underscoring its public health importance. ^{2 4 5 6 7}

Who Is on the Research Team?

Mamta K Jain, MD, MPH

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for primary care providers who order blood tests as part of their standard patient care. It's not for patients directly, but it will affect how doctors screen for HIV, hepatitis B, and hepatitis C during routine checks.

Inclusion Criteria

Outpatient primary care adult providers at participating institutions

My healthcare provider agrees to participate in this study.

Providers must intend to continue their current practice for at least 12 months

Exclusion Criteria

Providers who do not consent to participate

Sub-specialty providers

Pediatric providers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 months

Intervention

Providers are randomized to either a control arm or a triple-testing order panel intervention arm, with a crossover at 6 months or after 1000 patient test orders.

6 months

Crossover

Providers switch arms halfway through the study, defined as 6 months or the point at which a total of 1000 patients have BBV test orders.

6 months

Follow-up

Participants are monitored for incidences of HIV, HBV, and HCV diagnoses, and cost efficiency is analyzed.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• HIV/HBV/HCV Triple Screening

Trial Overview The study compares two approaches: one where doctors continue with current test ordering practices (control), and another where a pre-selected panel prompts them to screen for all three viruses whenever they order one such test (intervention). Providers switch methods after 6 months or 1000 tests.

How Is the Trial Designed?

Group I: Triple testing order panel intervention arm Experimental Treatment 1 Intervention

Triple testing order panel intervention arm: 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 be coupled with orders for the respective screening blood tests for the other two BBVs to be selected by default in a single order panel.

Group II: Control Arm Active Control 1 Intervention

Control arm: no change to currently available orders/order panels (the control arm is standard of care)

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10170094/

HCV, HIV AND HBV rapid test diagnosis in non-clinical ... Hence it gave a sensitivity of 98.8% (95% CI 93.4, 100.0), a specificity of 100.0% (95% CI 98.3, 100.0), and an accuracy of 99.7% (95% CI 98.1, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S104727972500136X

Value of public health interventions for HIV, HBV and HCV ... The results of the sensitivity analysis revealed that if the percentage of the population screened ranged from 11.2 % to 25.0 %, then 1028 HIV, 1162 HCV and 375 ...

3. cdc.gov cdc.gov/mmwr/volumes/72/rr/rr7201a1.htm

Screening and Testing for Hepatitis B Virus Infection New recommendations include hepatitis B screening using three laboratory tests at least once during a lifetime for adults aged ≥18 years.

4. academic.oup.com academic.oup.com/ofid/article/11/2/ofad666/7516102

A Systematic Review to Provide Evidence to Support World ... This systematic review aims to provide evidence for this policy, by identifying the prevalence of these BBVs and discussing the costs of available triple tests.

5. bmjopen.bmj.com bmjopen.bmj.com/content/14/6/e075315

Development of a risk prediction score for screening ... The TROD screen questionnaire showed good overall performance for predicting HIV, HBV and HCV infections among migrants in OFII centres.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9692379/

The Screening of Hepatitis B and Hepatitis C Virus Infection ... The rate of negative results for all the HBV serological tests among the inpatients with HIV infection was 24.2% (118/487) (Table 1). Table 1. The distribution ...

7. who.int who.int/news/item/15-07-2025-who-prequalifies-the-first-triple-diagnostic-test-for-hiv--hepatitis-b-and-syphilis--a-milestone-toward-global-disease-elimination-goals

WHO prequalifies the first triple diagnostic test for HIV ... WHO prequalifies the first triple diagnostic test for HIV, hepatitis B and syphilis, a milestone toward global disease elimination goals. 15 ...