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临床试验/NCT03149627
NCT03149627已完成不适用

Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 5,003 人开始时间: 2017年6月7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
5,003
试验地点
1
主要终点
Prevalence and correlates of lifetime HBV infection

研究概览

简要总结

The purpose of this study is to recruit a random and representative sample of individuals within several Zambian communities for markers of Hepatitis B Virus (HBV) and to characterize chronic HBV infection and indications for treatment.

详细描述

The Zambian Ministry of Health (MoH) considers viral hepatitis a significant public health threat; however, there are limited representative data on HBV burden, risk factors, clinical significance, and interaction with co-infections and co-morbidities that are common in Zambia. In collaboration with the Central Statistical Office, MoH, and Centers for Disease Control and Prevention, the Zambia Population-Based HIV Impact Assessment (ZAMPHIA) will be testing a representative sample of Zambians across all 10 provinces for HBV infection. This is an important first step toward understanding the burden of disease and its distribution across the country. The goal of this study is to generate further information for consumption by local and regional health policymakers. The Investigators will research the epidemiologic risk factors for lifetime and current HBV infection, characterize clinical features of chronic HIV in Zambia, and describe key virological, serological, and comorbid factors that are critical to developing the best policies for HBV control in Zambia.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Part 1: 18 years or older, current residence in selected household
  • Part 2: Participant in part 1 of the study, HBsAg-positive by rapid point-of-care test

排除标准

  • Part 1: Unable to provide informed consent
  • Part 2: Unwilling to travel to a hospital in their province

结局指标

主要结局

Prevalence and correlates of lifetime HBV infection

时间窗: baseline

Estimates of the prevalence and correlates of lifetime HBV infection defined as hepatitis B core antibody (HBcAb) positivity and chronic HBV infection defined as HBsAg positivity in randomly selected households in Lusaka Province in Zambia. Identification of individual (such as age or sex) and community (such as province) correlates of lifetime and chronic HBV infection.

次要结局

  • Proportion of Zambian adults who require antiviral therapy for chronic HBV infection(within 1 month of part 1)
  • Frequency of primary drug resistance mutations.(within 1 month of part 1)
  • Clinical phenotypes of patients with chronic HBV infection(within 1 month of part 1)
  • The proportion of patients with chronic HBV infection who have significant liver fibrosis or cirrhosis.(within 1 month of part 1)
  • Hepatosplenic schistosomiasis co-infection with liver fibrosis markers among patients with chronic HBV infection(within 1 month of part 1)
  • Unhealthy alcohol use in HBV-positive patients(within 1 month of part 1)
  • HIV prevalence in HBV-patients(within 1 month of part 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Vinikoor

Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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