Active Delta Referral — screening to care pathway
"Referral Attivo" Delta, Dallo Screening Alla Presa in Carico.
This project will try an automatic 'HDV-reflex' screening to find how common hepatitis D is among adults with hepatitis B who are hospitalized or served by addiction and prison health services in Bergamo.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 244 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS Academic / other |
| Locations | 3 sites (Bergamo and 2 other locations) |
| Trial ID | NCT07317011 on ClinicalTrials.gov |
What this trial studies
Hepatitis Delta is the most severe chronic viral hepatitis and occurs only in people who are HBsAg-positive, but it is often missed because routine automatic screening is not in place. Starting in 2025 the project will implement an 'HDV-reflex' test that automatically checks anti-HDV in HBsAg-positive adults at the Department of Medicine, the SerD, and the Prison Health Service of ASST Papa Giovanni XXIII in Bergamo. The team will estimate anti-HDV prevalence in these settings and compare the results with existing outpatient data. The program also intends to improve referral pathways to hepatology and enable earlier use of new antiviral treatment options.
Who should consider this trial
Good fit: Adults (≥18 years) who are HBsAg-positive and hospitalized at ASST Papa Giovanni XXIII's Department of Medicine or attending its SerD or Prison Health Service, and who provide informed consent.
Not a fit: People who are HBsAg-negative, those receiving care outside the specified Bergamo sites, or individuals who do not provide informed consent are not expected to benefit from this screening initiative.
Why it matters
Potential benefit: If successful, the approach could identify many previously undiagnosed HDV cases earlier, enabling timely treatment and reducing the number of patients presenting with advanced HDV-related liver disease.
How similar studies have performed: Reflex HDV screening strategies have been implemented successfully in other countries and have increased detection of HDV among HBV-positive patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≥18 years. * Hospitalized at the Department of Medicine of ASST Papa Giovanni XXIII in Bergamo, or attending the SerD or the Penitentiary Health Service of Bergamo. * HBsAg positivity. * Obtaining informed consent. Exclusion Criteria: * Lack of informed consent
Where this trial is running
Bergamo and 2 other locations
- ASST PAPA GIOVANNI XXIII - Medicine Dept. — Bergamo, Italy (Recruiting)
- ASST Papa Giovanni XXIII - SerD — Bergamo, Italy (Recruiting)
- ASST Papa Giovanni XXIII - SS Sanità Penitenziaria — Bergamo, Italy (Recruiting)
Study contacts
- Study coordinator: Eleonora Sfreddo
- Email: sperimentazioni@fondazionefrom.it
- Phone: +39 0352675134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.