Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06248580

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

Led by Yaşar Bayındır, MD · Updated on 2024-08-12

20000

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

Sponsors

Y

Yaşar Bayındır, MD

Lead Sponsor

S

SOUTHEAST NEUROLOGY AND INFECTIOUS DISEASES SOCIETY

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to determine how common hepatitis Delta virus (HDV) infections are and the outlook for HDV patients in southeastern Turkey. It focuses on training 250 family physicians in four provinces to improve diagnosis and management of hepatitis B virus (HBV), HDV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) infections. The study highlights the importance of evaluating patients with HDV for co-infections and liver fibrosis using non-invasive methods to support the national hepatitis elimination program. The study includes two main groups: 250 family physicians who will receive training sessions led by infectious disease or gastroenterology specialists, and 20,000 patients who test positive for hepatitis B surface antigen (HBsAg). Family physicians will be educated about HBV and HDV complications, and all HBsAg positive patients will be screened for HDV infection using Anti Delta ELISA tests. Patients who test positive for HDV will also be evaluated for HIV and HCV co-infections and assessed for liver fibrosis using Fibroscan and FIB-4 scoring. Participants will have their biochemical and virological status evaluated, and liver fibrosis will be measured with non-invasive methods. A survey will assess family physicians' knowledge before and after training. The study will track the frequency of HDV and co-infections from April to September 2024 and complete data analysis by January 2025. Patients needing treatment or transplantation will be managed according to guidelines, with the goal of better understanding HDV prevalence and patient outcomes in the region.

CONDITIONS

Brief Title

Find HDV and Determine Its Status in Turkey

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Positive for hepatitis B surface antigen (HBsAg) for at least six months
  • Citizen of the Republic of Türkiye
Not Eligible

You will not qualify if you...

  • There are no exclusion criteria in this study.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - April 2024 to September 2024

Participants who are HBsAg positive are tested for HDV infection using Anti Delta by ELISA. Those with Anti-Delta positivity are further evaluated for HIV and HCV co-infections and assessed for liver fibrosis using non-invasive methods including Fibroscan, FIB-4, and Child Pugh scoring.

1 to 2 visits depending on test results

Long-term Monitoring

Duration - Up to December 2024

Participants diagnosed with HDV infection are monitored for disease progression and evaluated for the need for treatment or transplantation in accordance with national and international guidelines. Family physicians are also trained and surveyed to support patient management.

Follow-up visits as needed

Trial Site Locations

Total: 2 locations

1

Guven Hospital

Ankara, Turkey (Türkiye), 06850

Actively Recruiting

2

Dicle University, Faculty of Medicine

Diyarbakır, Turkey (Türkiye)

Actively Recruiting

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Research Team

Y

Yaşar Bayındır, MD

M

Mustafa Kemal Çelen, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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