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临床试验/NCT03215732
NCT03215732已完成不适用

Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B Virus Infection in the Rural Area of Niakhar, Senegal

ANRS, Emerging Infectious Diseases1 个研究点 分布在 1 个国家目标入组 3,119 人开始时间: 2017年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,119
试验地点
1
主要终点
Prevalence of chronic HBV infection

研究概览

简要总结

This study aims at estimating the prevalence of chronic hepatitis B virus (HBV) infection in rural Senegal (area of Niakhar) and at evaluating the associated burden in terms of both health-related and socio-economic consequences.

详细描述

The prevalence of chronic HBV infection in Senegal is among the highest worldwide (10% to 17%) but available prevalence estimates relie on studies conducted in specific subgroups (such as military, pregnant women or blood donors).

The prevalence of HBV chronic infection remains undocumented in the general population of Senegal, and its health-related and socio-economic consequences need to be estimated.

This research is based on a cross-sectional survey conducted in the general population with collection of biological, socio-behavioral and economic data at two levels (at the participants' home and in healthcare centers) in the area of Niakhar (located at 135 kms at the East of Dakar).

The research includes three phases as follows:

(i) Preliminary phase: information and communication about the research within the community, training of stakeholders and pilot survey

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (i) Living in a household of the research zone (individuals living within participating households for at least 6 months, even non permanently: seasonal workers or individuals studying outside the Niakhar zone)
  • (ii) Being aged of at least 6 months
  • (iii) Giving informed consent to participate in the research

排除标准

  • (i) Being an adult unable to sign informed consent
  • (ii) Being a child whose parents or legal guardian is not present in the household at the time of the survey

结局指标

主要结局

Prevalence of chronic HBV infection

时间窗: At baseline

HBs Ag positivity with a positive anti-HBc antibody and a negative anti-HBs antibody

次要结局

  • Morbidity associated with chronic HBV infection in the Niakhar area(6 months)
  • Number of quality-adjusted life years(QALYs) lost in the absence of HBV treatment(6 months)
  • Quality of life and living conditions of HBV-infected individuals and of their households(6 months)
  • Prevalence of chronic HBV infection in age classes '0-15 years; 15-35 years, more than 35 years), and in women of childbearing age(At baseline)
  • HBV vaccine coverage (in children born after 2004, year of the introduction of the vaccine in the national program)(At baseline)
  • HBV vaccine efficacy (in children born after 2004, year of the introduction of the vaccine in the national program)(At baseline)
  • Mortality associated with chronic HBV infection in the Niakhar area(6 months)
  • HBV treatment needs in the Niakhar area and in the country(At baseline)
  • Number of QALYs gained with different scenario of access to HBV treatment(6 months)
  • Total cost(6 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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