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

NCT ID: NCT03149627

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5003 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-07

Study Completion Date

2018-12-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HBV Alcoholic Hepatitis Liver Fibroses

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Individuals from selected households

Individuals residing in selected households in Lusaka Province, Zambia.

Estimates - prevalence of lifetime/chronic HBV infection

Intervention Type OTHER

Estimation 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.

Interventions

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Estimates - prevalence of lifetime/chronic HBV infection

Estimation 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Teaching Hospital

UNKNOWN

Sponsor Role collaborator

Tropical Gastroenterology and Nutrition Group

UNKNOWN

Sponsor Role collaborator

Centre for Infectious Disease Research in Zambia

OTHER

Sponsor Role collaborator

Ministry of Health, Zambia

OTHER_GOV

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Michael Vinikoor

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael J Vinikoor, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University Teaching Hospital

Lusaka, , Zambia

Site Status

Countries

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Zambia

Other Identifiers

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X160524001

Identifier Type: -

Identifier Source: org_study_id

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