Rapid Screening for Hepatitis C & B

Recruiting at 1 trial location

Overseen By Bethany Barber, RN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Jordan Feld

Disqualifiers: End of life < 6 months, Active COVID-19, Life-threatening conditions, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 92

2920 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, quicker way to screen for hepatitis C and B using rapid point-of-care tests instead of the usual blood draw method. The goal is to determine if this faster method can improve diagnosis rates and help patients receive care sooner. The study compares the rapid testing approach to the traditional method to evaluate its effectiveness. Suitable participants include those admitted to certain hospital units without urgent life-threatening conditions. As a Phase 4 trial, the rapid testing method has already received FDA approval and proven effective, and this research aims to understand how it can benefit more patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for these screening methods?

Research has shown that the OraQuick® Rapid Anti-HCV Test and the Xpert® HCV RNA point-of-care tests are generally safe for people. These tests quickly check for the hepatitis C virus (HCV) and have received FDA approval for this purpose.

The OraQuick® test is a one-time-use test that detects antibodies, indicating past exposure to the virus. Studies have found it to be well-tolerated, with no significant side effects reported. Similarly, the Xpert® HCV RNA test identifies the actual virus in the blood using an automated process. It is designed to be fast and reliable, with no major safety concerns found in research.

Both tests have been widely used without reports of serious side effects, suggesting they are safe options for quickly screening for hepatitis C. ^{1 2 3 4 5}

Why are researchers enthusiastic about this trial?

Researchers are excited about this trial because it explores rapid point-of-care testing for Hepatitis C and B, which could significantly improve screening processes. Unlike conventional serum testing, which requires lab processing and longer wait times for results, the rapid point-of-care test provides immediate feedback using the OraQuick® Rapid Anti-HCV Test and Xpert® HCV RNA testing. This approach could streamline diagnosis, allowing for quicker treatment decisions, enhancing patient outcomes, and potentially reducing the spread of these infections. By comparing these methods, the trial aims to determine if the faster approach is just as accurate, which could revolutionize how these viral infections are detected and managed.

What evidence suggests that this trial's rapid screening methods could be effective for hepatitis C and B?

This trial will compare two screening methods for Hepatitis C. Research has shown that quick tests, such as the OraQuick® Rapid Anti-HCV Test used in the Rapid Point-of-Care Testing arm, effectively detect hepatitis C antibodies quickly. These tests provide results in about 20 minutes, much faster than older methods, enabling faster access to medical care, especially in challenging situations. After a positive result, the Xpert® HCV RNA test, also part of the Rapid Point-of-Care Testing arm, can confirm the virus in about an hour and works with various virus types. These tools have been successfully used in various settings, demonstrating their ability to improve hepatitis C diagnosis and treatment. Meanwhile, participants in the Conventional Serum Testing arm will undergo conventional HCV antibody serology, with further testing for HCV RNA if the initial screen is positive. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who are admitted to General Internal Medicine Inpatient Units at Toronto General Hospital (TGH) or Toronto Western Hospital (TWH). It's designed to test a new rapid screening method for Hepatitis A, B, and C in patients during their hospital stay.

Inclusion Criteria

Patients admitted to GIMIUs at TGH or TWH

Exclusion Criteria

I currently have an active COVID-19 infection.

I cannot or do not want to give permission for treatment.

Patients whose end of life is expected to be less than 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Rapid Point-of-Care Testing

Participants will be screened using the OraQuick® Rapid Anti-HCV Point-of-Care Test and if screen positive, an additional whole blood sample will be collected and tested for HCV RNA using Xpert® HCV RNA point-of-care testing

1 day

1 visit (in-person)

Follow-up

Participants are monitored for linkage to care and sustained virological response at 12 weeks after treatment completion

2 years

Contact at 90 days and 1 year post-enrolment

What Are the Treatments Tested in This Trial?

Interventions

• Quality Improvement

Trial Overview The study is testing the effectiveness of a quality improvement intervention that involves rapid screening methods for viral hepatitis. This approach aims to provide same-day results, potentially improving diagnosis rates and immediate care engagement compared to traditional weeks-long serum testing processes.

How Is the Trial Designed?

Group I: Rapid Point-of-Care Testing Experimental Treatment 1 Intervention

Participants will be screened using the OraQuick® Rapid Anti-HCV Point-of-Care Test (OraSure) and if screen positive, an additional whole blood sample will be collected and tested for HCV RNA using Xpert® HCV RNA (Cepheid) point-of-care testing and confirmed using a standard commercial assay.

Group II: Conventional Serum Testing Active Control 1 Intervention

Participants will be screened by conventional HCV antibody (anti-HCV) serology and if screen positive, a second sample will be collected and tested for HCV RNA using a standard commercial assay.

Who Is Running the Clinical Trial?

Jordan Feld

Lead Sponsor

Trials

2

Recruited

3,000+

Published Research Related to This Trial

A quality improvement initiative successfully increased hepatitis B virus (HBV) screening rates by 20% over two years in family health centers serving high-risk refugee populations, despite challenges posed by the COVID-19 pandemic.

The project utilized electronic medical record tools to identify individuals from HBV-endemic regions, resulting in a notable HBV detection rate of 8.2% to 12.8% among those screened, highlighting the effectiveness of targeted screening strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Hepatitis B Screening at Family Health Centers Using Quality Improvement and Electronic Medical Record Tools. Huang, JS., Cruz, R., Schwarz, KB., et al.[2023]

A community-based screening program in rural Taiwan successfully tested 4552 individuals for hepatitis B and C, revealing significant prevalence rates of 12.1% for HBV and 15.3% for HCV, highlighting the importance of outreach in identifying viral infections in underserved populations.

Using quantitative tests for HBV and HCV significantly improved screening efficacy and reduced the referral burden by 80.2%, allowing for better patient allocation and management in areas with high rates of infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Village-to-village screening for hepatitis B and C using quantitative HBsAg and anti-HCV testing with reflex HCV core antigen tests in the remote communities of a resource-rich setting: a population-based prospective cohort study. Chang, TS., Chang, KC., Chen, WM., et al.[2021]

The quality improvement system for short-stay surgery in hernia repair and cholecystectomy showed high patient satisfaction, although there was a notable gap in providing post-discharge support, as indicated by low satisfaction with competencies to manage home care issues.

Postoperative outcomes were positive, with a significant percentage of patients reporting no complications and health-related quality of life improving to meet or exceed population norms by six months after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient reported process and outcome indicators for clinical audit in short-stay surgery]. Bitzer, EM., Nickel, S., Lorenz, C., et al.[2008]

In a study involving 21,008 patients across 51 private practices, the prevalence of hepatitis B and C infections was found to be significant, with 85% of HBsAg positive and 65% of anti-HCV positive individuals previously unaware of their infections.

Guideline-based screening strategies effectively identified 82% of undiagnosed hepatitis B and 83% of unknown hepatitis C cases by focusing on specific risk factors and elevated ALT levels, demonstrating the importance of targeted screening in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of elevated ALT values, HBsAg, and anti-HCV in the primary care setting and evaluation of guideline defined hepatitis risk scenarios. Wolffram, I., Petroff, D., Bätz, O., et al.[2015]

The safety profile of medications can change after they are approved for public use, as new safety issues may arise that were not identified during clinical trials.

Regulatory agencies, like the FDA, actively monitor medication safety through various methods, including analyzing adverse experience reports and using large electronic databases to detect potential safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. Sharrar, RG., Dieck, GS.[2021]

A multidisciplinary team applied total quality management principles to enhance the infant metabolic screening program at a large urban hospital, leading to significant improvements in specimen quality, timely delivery for testing, and accurate documentation of collection dates within just 4 months.

The positive changes in screening indicators were sustained over a 3-year period, demonstrating that quality improvement initiatives not only benefit patient care but can also enhance staff efficiency and potentially lower costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant metabolic screening: a total quality management approach. Forsberg, SA.[2022]

The National Surgical Quality Improvement Program (NSQIP) collects detailed clinical data from hospitals to provide risk-adjusted outcomes, helping to improve surgical mortality and morbidity rates.

By analyzing NSQIP data, hospitals can identify and address specific issues, such as postoperative respiratory complications, leading to targeted performance improvement strategies and collaborative efforts among participating hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The power of the National Surgical Quality Improvement Program--achieving a zero pneumonia rate in general surgery patients. Fuchshuber, PR., Greif, W., Tidwell, CR., et al.[2022]

A quality-improvement program (QIP) in postoperative pain management led to significant improvements in surgical department scores (SDS) across seven departments, with all departments scoring above 45 after targeted training sessions in 2007.

However, between 2009 and 2012, there was a notable decline in quality, with six out of seven departments showing decreased scores and significant drops in adherence to key pain management criteria, highlighting the need for regular audits and ongoing training to maintain standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postoperative pain management on surgical wards; impact of using a validated reference tool in a short, medium and long term]. Binhas, M., Roudot-Thoraval, F., Alves, A., et al.[2012]

Out of 269 clients screened for hepatitis C, a significant number received vaccinations for hepatitis A (78.9%) and B (84.9%), indicating effective follow-up care after screening.

While 51.2% of clients reported adverse effects related to their positive anti-HCV status, such as difficulties in obtaining health insurance, 86.0% expressed satisfaction with their decision to get tested, suggesting that screening can lead to positive health behaviors despite some challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits and adverse effects of hepatitis C screening: early results of a screening program. Trepka, MJ., Zhang, G., Leguen, F., et al.[2019]

A quality improvement initiative successfully increased HCV screening rates among individuals born between 1945-1965 from less than 3% to 30.3% within 24 months, identifying a significant number of previously undiagnosed infections.

Of those screened, 43.5% tested positive for HCV antibodies, and 95.3% of those positive had active infections, with 70% linked to hepatology care, demonstrating the effectiveness of targeted screening and education efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving hepatitis C screening and diagnosis in patients born between 1945 and 1965 in a safety-net primary care clinic. Bakhai, S., Nallapeta, N., El-Atoum, M., et al.[2019]

In a study involving 43,618 Alaska natives who received 101,360 doses of the hepatitis B vaccine, only 39 individuals reported possible adverse reactions, indicating a low incidence of serious side effects.

The most common adverse reactions were mild and included prolonged myalgia/arthralgia, skin rashes, and dizziness, with no increased risk of Guillain-Barré syndrome found among vaccine recipients, supporting the vaccine's overall safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency of adverse reactions to hepatitis B vaccine in 43,618 persons. McMahon, BJ., Helminiak, C., Wainwright, RB., et al.[2019]

Implementing a targeted hepatitis C screening protocol for patients born between 1945 and 1965 significantly increased screening rates in a primary care setting, from an average of 3 patients per month to 25 patients per month after the intervention.

The screening protocol led to a rise in screening rates from 15% to 66% over two years, demonstrating its effectiveness in identifying undiagnosed chronic hepatitis C cases, which is crucial for preventing serious health complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Birth Cohort Screening for Chronic Hepatitis C in a Primary Care Clinic with Panel Management. Balkissoon, CJ., Hampton, MD.[2020]

Approximately 4 million people in the U.S. are infected with hepatitis C, with about 50% unaware of their infection, highlighting the need for effective public health screening programs.

Current anti-HCV antibody tests are highly sensitive (>95%) and cost-effective (around $80), making widespread screening feasible and beneficial for early detection and treatment, which can improve health outcomes and reduce transmission risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of screening patients for hepatitis C. Gordon, FD.[2019]

The quality improvement project at our resident clinic successfully increased hepatitis C screening rates to align with CDC guidelines, revealing a prevalence of 1.9% in our population, which is higher than the national average.

We effectively treated patients with Tenncare (Medicaid equivalent) and uninsured individuals by enhancing case identification, follow-up, and utilizing specialty pharmacies and standardized order sets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality improvement in hepatitis C screening and treatment in a primary care resident clinic. Doering, T., Williamson, S., Gadalla, M.[2020]

A new statistical procedure was developed to compare the safety of hepatitis C treatments by analyzing adverse events (AEs) reported in the FDA Adverse Event Reporting System and Electronic Health Records, revealing significant differences in AE rates between drugs approved before 2011 and those approved after 2013.

The study found that newer hepatitis C therapies had different safety profiles compared to older treatments, indicating the importance of ongoing monitoring and evaluation of drug safety using post-market data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing drug safety of hepatitis C therapies using post-market data. Huang, J., Zhang, X., Tong, J., et al.[2020]

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2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jvh.70066

Early Read‐Time Performance of the OraQuick HCV Rapid ... Rapid point-of-care tests for hepatitis C virus (HCV) provide results in 20 min and allow linkage to care, particularly for difficult-to ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf8/P080027S001b.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) The OraQuick® HCV Rapid Antibody Test is a single-use immunoassay for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in fingerstick ...

4. cepheid.com cepheid.com/en-US/tests/blood-virology-womens-health-sexual-health/xpert-hcv-info.html

Xpert® HCV Info This simple to use test detects the full range of relevant HCV genotypes in about an hour and can be performed on a small volume of blood collected via ...

5. stacks.cdc.gov stacks.cdc.gov/view/cdc/164804/cdc_164804_DS1.pdf

Considerations for the Implementation of Point-of-Care ... This document describes programmatic considerations for the implementation point-of-care (POC) testing for hepatitis C virus (HCV) infection.

6. cepheid.com cepheid.com/en-US/tests/blood-virology-womens-health-sexual-health/xpert-hcv.html

Xpert HCV The Xpert HCV test utilizes an automated in vitro reverse transcription polymerase chain reaction (RT-PCR) to qualitatively detect hepatitis C virus (HCV) RNA.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf8/P080027b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The OraQuick® HCV Rapid Antibody Test is a single-use immunoassay for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in ...

8. orasure.com orasure.com/products/documentation/OraQuick-HCV.html

OraQuick HCV Test OraQuick HCV Rapid Antibody Test Safety Data Sheet - AUS-ENG. 06/19. Download. 19408. OraQuick HCV Rapid Antibody Test Safety Data Sheet - EU-ENG. 06/19.