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NCT Number: NCT05350865

Thailand HDV Cohort

There is very limited data of HDV in Thailand. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special population is unmet need. Therefore, this study plans to perform a nationwide survey of the prevalence and predictor of HDV among people uses drugs (PWID) with and without HIV, HBV/HIV (MSM vs non MSM), HBV related cirrhosis. Findinds from this study will provide the scientific community to understand how important HDV is among HBV patients, this could be used to develop strategies for HDV screening and treatment

Recruiting

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Key information

Conditions

HDV Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HIV-NAT, Thai Red Cross - AIDS Research Centre, Bangkok, Thailand

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About this study

The prevalence of HDV remains ill-defined, mainly for lack of appropriate testing and screening. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special population is unmet need. This data will inform the guideline whether HDV screening among HBV/HIV is required. This study has plans to perform a nationwide survey of the prevalence and predictor of HDV among people uses drugs (PWID) with and without HIV, HBV/HIV (MSM vs non MSM), HBV related cirrhosis. This Nationwide survey of HDV is collaboration between Thai liver society, Thai AIDS society, Thai Red Cross AIDS research centre, Faculty of Medicine Chulalongkorn University, and AIDS TB and STI Control Division, Department of Disease control, MOPH Thailand. All findings will be shared and discussed to develop the National guideline for screening, treatment and care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, aged 18 years and older
  • Chronically-infected with HBV, as defined by:

Positive Hepatitis B surface antigen HBsAg) or HBV DNA result with a subsequent positive HBsAg or HBV DNA result at least 6 months after first positive result

  • Provide signed and dated informed consent form.

Exclusion criteria

Non chronic HBV

Treatment and study plan

Primary outcomes

  1. prevalence of HDV

    Time frame: 1 year

    prevalence of HDV in patients with cirrhosis

  2. prevalence of HDV

    Time frame: 1 year

    prevalence of HDV in patients with non cirrhosis

  3. prevalence of HDV

    Time frame: 1 year

    prevalence of HDV in HIV positive people with injecting drug use

  4. prevalence of HDV

    Time frame: 1 year

    prevalence of HDV in HIV negative people with injecting drug use

  5. prevalence of HDV

    Time frame: 1 year

    prevalence of HDV among HBV/HIV men who have sex with men

  6. prevalence of HDV

    Time frame: 1 year

    prevalence of HDV among HBV/HIV cisgender male patients

  7. prevalence of HDV

    Time frame: 1 year

    prevalence of HDV among prisoners

  8. proportion of participants with detectable HDV RNA among seropositive anti HDV

    Time frame: 1 year

    proportion of participants with detectable HDV RNA among seropositive anti HDV with cirrhosis

  9. proportion of participants with detectable HDV RNA among seropositive anti HDV

    Time frame: 1 year

    proportion of participants with detectable HDV RNA among seropositive anti HDV without cirrhosis

  10. proportion of participants with detectable HDV RNA among seropositive anti HDV

    Time frame: 1 year

    proportion of participants with detectable HDV RNA among seropositive anti HDV in PWID with HIV

  11. proportion of participants with detectable HDV RNA among seropositive anti HDV

    Time frame: 1 year

    proportion of participants with detectable HDV RNA among seropositive anti HDV in PWID without HIV

  12. proportion of participants with detectable HDV RNA among seropositive anti HDV

    Time frame: 1 year

    proportion of participants with detectable HDV RNA among seropositive anti HDV with HIV/HBV MSM

  13. proportion of participants with detectable HDV RNA among seropositive anti HDV

    Time frame: 1 year

    proportion of participants with detectable HDV RNA among seropositive anti HDV in HIV/HBV cisgender males

  14. proportion of participants with detectable HDV RNA among seropositive anti HDV

    Time frame: 1 year

    proportion of participants with detectable HDV RNA among seropositive anti HDV in prisoners

  15. predictive risk of HDV infection

    Time frame: 1 year

    predictive risk of HDV infection

  16. HDV subtype

    Time frame: 1 year

    HDV subtype among people with cirrhosis

  17. HDV subtype

    Time frame: 1 year

    HDV subtype among people without cirrhosis

  18. HDV subtype

    Time frame: 1 year

    HDV subtype in PWID with HIV

  19. HDV subtype

    Time frame: 1 year

    HDV subtype in PWID without HIV

  20. HDV subtype

    Time frame: 1 year

    HDV subtype in HBV/HIV MSM

  21. HDV subtype

    Time frame: 1 year

    HDV subtype in HBV/HIV cisgender males

  22. HDV subtype

    Time frame: 1 year

    HDV subtype in prisoners

  23. performance of antiHDV commercial kits

    Time frame: 1 year

    performance of antiHDV commercial kits

  24. prevalence of HDV among HBV/HIV before combination antiretroviral therapy

    Time frame: 1 year

    prevalence of HDV among HBV/HIV before combination antiretroviral therapy

  25. prevalence of HDV among HBV/HIV after combination antiretroviral therapy

    Time frame: 1 year

    prevalence of HDV among HBV/HIV after combination antiretroviral therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Chatsuda Auchieng

CONTACT

[email protected]

6626523040 ext. 118

Pirapon J Ohata, BSc

CONTACT

[email protected]

6626523040 ext. 147

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • Gilead Sciences
  • King Chulalongkorn Memorial Hospital
  • Siriraj Hospital
  • Taksin Hospital
  • Thai Red Cross AIDS Research Centre

Registry information

Official study title

Prevalence, Risk Factor and Clinical Significance of Hepatitis D Virus Infection Among Targeted High Risk Population in Thailand: Nationwide Survey 2022-2024

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 28, 2022
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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