Find HDV and Determine Its Status in Turkey (SITUHDVATION)

Find HDV and Determine Its Status in Turkey "SITU(HD)VATION"

The aim of these study to determine the prevalence of hepatitis Delta virus (HDV) infections and the prognosis of HDV patients in Turkey's southeast. The investigators intend to arrange training sessions for 250 family physicians in Diyarbakir, Batman, Mardin, and Sanliurfa in order to determine those goals. The investigators will talk about diagnosing hepatitis B virus (HBV), HDV, hepatitis C virus (HCV), and Human Immunodeficiency virus (HIV) infections during these events. To ensure that patients with simultaneous HDV infection are evaluated for HIV/HCV and to detect liver fibrosis with a non-invasive method.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma; Fibrosis, Liver; Cirrhosis, Liver; Chronic Hepatitis D Infection; Transmission Vertical
• Intervention / Treatment: Diagnostic test: Anti Delta

Detailed Description

Study Objectives:

The aim of these study to determine the prevalence of HDV infections and the prognosis of HDV patients in Turkey's southeast. The investigators intend to arrange training sessions for 250 family physicians in Diyarbakir, Batman, Mardin, and Sanliurfa in order to determine those goals. The investigators will talk about diagnosing HBV, HDV, HCV, and HIV infections during these events. To ensure that patients with simultaneous HDV infection are evaluated for HIV/HCV and to detect liver fibrosis with a non-invasive method.

Primary Objectives:

To reveal the status of HDV infection in Turkey within the framework of the national hepatitis elimination program by providing training to family physicians.

Second Objectives:

• To determine the frequency and type of HDV in HBV patients (HDV/HCV co-infection).
• Providing HBV, HCV, HDV and HIV awareness training to family physicians.
• To determine the virological and liver fibrosis of patients with anti-Delta positivity.
• To determine the status of patients with HBV infection who are followed by family physicians.
• To ensure that patients with HDV infection are evaluated for liver cirrhosis and liver cancer.
• To determine the HDV/HIV co-infection rate.
• To determine the HDV/HCV co-infection rate.
• Determining the vertical transmission rate in viral hepatitis and contributing to elimination by emphasizing the importance of this rate.

Study Population:

To ensure that 20,000 patients with HBsAg positivity in Diyarbakir, Mardin, Batman and Sanliurfa are evaluated for HDV infection. To investigate HDV positive patients for liver fibrosis using the fibroscan method.

Number of Volunteers to Participate in the Study:

It is planned to include a total of 20,000 patients with HBsAg positivity from four provinces in this study.

Study Design:

Hepatitis Delta Virus infection poses a greater risk of developing both cirrhosis and liver cancer than other viral hepatitis agents. The Southeastern Anatolia region where HDV infection is most common in Turkey. It is planned to include four provinces (Diyarbakir, Batman, Mardin and Sanliurfa) in this study. In this study, family physicians will be reached through the Health Directorate of each province.

All Family Physicians will be educated about the prognosis and complications of HBV and especially HDV infection. The training will be carried out by the Infectious Diseases or Gastroenterology specialists of that province. Anti-Delta will be tested in all patients applying to health institutions. At the same time, all HBsAg positive patients followed by each family physician will be evaluated for the presence of HDV infection. All patients with anti-Delta positivity will be tested for HIV and HCV to determine their HDV/HIV co-infection and HDV/HCV co-infection status. Simultaneously, the liver fibrosis of patients with Anti-Delta positivity will be evaluated by the fibroscan method. Fibrosis-4 (FIB-4) and Child Pugh scoring will be performed on all patients simultaneously.

After receiving ethics committee approval for this study, the data collection process for family physicians' training and follow-up patients will be completed between April and July 2024. In total, it is anticipated to reach 250 Family Physicians in the entire region. In addition, demographic characteristics of HDV patients will be determined by reaching the Infectious Diseases and Gastroenterology Centers in four provinces. A five-question survey would be organized for all family physicians before and after the training in order to measure their knowledge level and evaluate the contribution of the training. This survey will be applied and analyzed via Slido.

After determining the biochemical and virological status of all HDV infections detected in four provinces, fibrosis of the liver will be measured with Fibroscan and FIB-4, which are non-invasive methods. As a result of the study, it is aimed to diagnose an estimated 1000 HDV-infected patients and score their liver fibrosis. It is aimed to complete the biochemical, virological, demographic and liver fibrosis status and statistical analyzes of all HDV-infected patients by 31.12.2024. The status of all patients in need of treatment or transplantation will be determined and their follow-up and treatment will be carried out in line with the recommendations of international and national treatment guidelines. The writing phase of all analyzed data will be completed and finalized by 31.01.2025.

One of the important reasons why both hepatitis B infection (HBV) and HDV infections are common is related to the fact that until recently vertical transmission was an important risk factor.

Both the diagnostic approach and follow-up and effective treatment options for HDV infections are still limited. It is also clearly known that HDV infection carries a higher risk of hepatocellular carcinoma (HCC) and cirrhosis than HBV infection. It is known that 90% of patients with viral hepatitis origin who are transplant candidates in our country have HDV infection.

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Yaşar Bayındır, MD; Phone Number: 00905323659909; Email: yasar.bayindir@guven.com.tr
• Study Contact Backup: Name: Mustafa Kemal Çelen, MD; Phone Number: 00905336207022

Study Locations

• Turkey
  • Ankara, Turkey, 06850
    • Recruiting
    • Guven Hospital
    • Contact: Yaşar Bayındır, MD; Phone Number: 00905323659909; Email: yasarb44@hotmail.com
    • Principal Investigator: Mustafa Kemal Çelen, MD
    • Sub-Investigator: Yasar Bayındır, MD
    • Sub-Investigator: Yeşim Taşova, MD
    • Sub-Investigator: Çiğdem Mermutluoğlu, MD
    • Sub-Investigator: Yakup Demir, MD
  • Diyarbakır, Turkey
    • Recruiting
    • Dicle University, Faculty of Medicine
    • Contact: Mustafa Celen, MD; Phone Number: 00905336207022; Email: mkcelen@hotmail.com
    • Contact: Cigdem Mermutluoglu, MD; Phone Number: 00905052252700; Email: cigdemmermut@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

To ensure that 20,000 patients with HBsAg positivity in Diyarbakir, Mardin, Batman and Sanliurfa are evaluated for HDV infection. To investigate HDV positive patients for liver fibrosis using the fibroscan method.

Description

Inclusion Criteria:

• Adults (Age≥18)
• Being HBsAg positive for at least six months
• Being a citizen of the Republic of Türkiye

Exclusion Criteria:

• There are no exclusion criteria in this study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Family Physicians; 1. 250 Family Physicians
HDV Screening; 2. 20,000 HBsAg positive patients	Diagnostic test: Anti Delta; Anti Delta by ELISA; Other Names: Fibroscan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of HDV in certain regions of Southern Anatolia	The primary endpoint of this study is to determine the frequency of HDV in certain regions of Southern Anatolia, and the virological and liver fibrosis status of patients with HDV infection.	01.04.2024-30.09.2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of HIV and HCV co-infection in HDV positive patients	To determine the rate of HIV and HCV co-infection in HDV positive patients and to determine the demographic characteristics of HDV infected cases.	01.04.2024-30.09.2024

Collaborators and Investigators

• Sponsor: Yaşar Bayındır, MD
• Collaborators: Gilead Sciences; SOUTHEAST NEUROLOGY AND INFECTIOUS DISEASES SOCIETY
• Investigators: Principal Investigator: Mustafa Kemal Çelen, MD, Dicle University, Medical Faculty, Department of Infectious Diseases

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 20, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; Liver Cirrhosis; Chronic hepatitis D
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Digestive System Neoplasms; Liver Diseases; Hepatitis, Viral, Human; Liver Neoplasms; Chronic Disease; Fibrosis; Hepatitis; Carcinoma, Hepatocellular; Hepatitis D; Hepatitis D, Chronic; Hepatitis, Chronic; Liver Cirrhosis
• Other Study ID Numbers: Guven Health Group

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study data will be shared with researchers periodically.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No