Untreated or Unknown HBV, HDV, and HCV in South-East Austria: See if People Need Care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-interventional, two-part observational study using retrospective NAT data from 2014–2023 to identify adults with detectable HBV DNA, HCV RNA, and HDV serology who have not been treated or tested for HDV. Eligible individuals will be validated in the electronic record system, and two cohorts (HBV with potential HDV lack of testing and HCV) will be formed. A prospective linkage-to-care phase will contact eligible patients to assess current care needs and, if appropriate, discuss treatment at the Medical University of Graz. Outcomes will include contact success, clinical assessment, treatment initiation, and virologic cure rates (SVR for HCV). The study hypothesizes that a substantial number of people remain unaware of their infection or HDV status and are not yet linked to care. Results will help quantify gaps in linkage to care and potential opportunities to improve patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The target population for the HCV cohort consists of individuals with detectable plasma HCV RNA at the latest observation.
* The target population for the HBV cohort consists of individuals with detectable plasma HBV RNA at any time and no recorded HDV testing or a positive HDV serology.

Exclusion Criteria:

* No valid SVRN (german: Sozialversicherungsnummer, english: Social insurance number)
* No contact details available
* Documented Sustained Virological Response (HCV cohort)
* Documented assessment of HDV status (HBV cohort)

Where it's running

• Department of Internal Medicine, Division of Gastroenterology and Hepatology
  Graz, Styra, Austria Recruiting

Study contacts

• Principal investigator: Vanessa Stadlbauer-Köllner, Univ. Prof. Dr. — Medical University of Graz, Department of Gastroenterology and Hepatology, Medical University of Graz
• Study coordinator: Vanessa Stadlbauer, Univ. Prof. Dr.
• Email: vanessa.stadlbauer@medunigraz.at
• Phone: 0043 316 385

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.