Prevalence, Risk Factor and Clinical Significance of Hepatitis D Virus Infection Among Targeted High Risk Population in Thailand: Nationwide Survey 2022-2024
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,152
- 试验地点
- 4
- 主要终点
- performance of antiHDV commercial kits
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Non chronic HBV
结局指标
主要结局
performance of antiHDV commercial kits
时间窗: 1 year
performance of antiHDV commercial kits
prevalence of HDV
时间窗: 1 year
prevalence of HDV among prisoners
proportion of participants with detectable HDV RNA among seropositive anti HDV
时间窗: 1 year
proportion of participants with detectable HDV RNA among seropositive anti HDV in prisoners
HDV subtype
时间窗: 1 year
HDV subtype in prisoners
predictive risk of HDV infection
时间窗: 1 year
predictive risk of HDV infection
prevalence of HDV among HBV/HIV before combination antiretroviral therapy
时间窗: 1 year
prevalence of HDV among HBV/HIV before combination antiretroviral therapy
prevalence of HDV among HBV/HIV after combination antiretroviral therapy
时间窗: 1 year
prevalence of HDV among HBV/HIV after combination antiretroviral therapy
次要结局
未报告次要终点