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Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults (HEP-ZED)

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Liver Fibroses
Alcoholic Hepatitis
HBV

Treatments

Other: Estimates - prevalence of lifetime/chronic HBV infection

Study type

Observational

Funder types

Other

Identifiers

NCT03149627
X160524001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

5,003 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

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

Trial design

5,003 participants in 1 patient group

Individuals from selected households
Description:
Individuals residing in selected households in Lusaka Province, Zambia.
Treatment:
Other: Estimates - prevalence of lifetime/chronic HBV infection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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