Thailand HDV Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HDV. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prevalence, Risk Factor and Clinical Significance of Hepatitis D Virus Infection Among Targeted High Risk Population in Thailand: Nationwide Survey 2022-2024
Overview
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
Detailed description
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.
Primary outcome measures
- prevalence of HDV [Time frame: 1 year]
- prevalence of HDV [Time frame: 1 year]
- prevalence of HDV [Time frame: 1 year]
- prevalence of HDV [Time frame: 1 year]
- prevalence of HDV [Time frame: 1 year]
- prevalence of HDV [Time frame: 1 year]
- prevalence of HDV [Time frame: 1 year]
- 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 [Time frame: 1 year]
- proportion of participants with detectable HDV RNA among seropositive anti HDV [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Thailand · 4 centers
- HIV-NAT, Thai Red Cross - AIDS Research Centre — Bangkok
- King memorial Chulalongkorn hospital — Bangkok
- Siriraj Hospital, Mahidol University — Bangkok
- Taksin Hospital — Bangkok
Identifiers
NCT: NCT05350865 · HIV-NAT 304