Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults
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
- 否
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
Michael Vinikoor
Assistant Professor
University of Alabama at Birmingham
