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NCT Number: NCT03158818

Chronic Hepatitis B Virus Infection in Zambia

Chronic hepatitis B virus infection is a common condition in Zambia. Among Zambian blood donors, up to 8% are chronically infected with HBV. Despite the burden, awareness of HBV is low in Zambia and the Ministry of Health is in early stages of development of guidelines for HBV screening, treatment, and prevention. The purpose of this clinical cohort study is to characterize the clinical features of chronic HBV infection at UTH and describe treatment and care outcomes. The investigators will enroll 500 adults and follow the cohort for up to 5 years to assess short and long-term viral, serologic, and liver outcomes such as cirrhosis and liver cancer.

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Key information

Conditions

HBV Adenocarcinoma Alcohol-Induced Disorders Alcohol-Related Disorders Alcoholic Hepatitis Carcinoma Carcinoma, Hepatocellular Chemically-Induced Disorders Cirrhosis, Liver Digestive System Diseases Digestive System Neoplasms Fibrosis Fibrosis, Liver Hepatitis Hepatitis D Hepatitis, Alcoholic Hepatitis, Delta Hepatitis, Viral, Human Hepatocellular Carcinoma Infections Liver Cirrhosis Liver Diseases Liver Diseases, Alcoholic Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Substance-Related Disorders Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tropical Gastroenterology and Nutrition Group

Lusaka, Zambia

About this study

Viral hepatitis is the #7 cause of death worldwide, yet it has been neglected when compared to other infectious diseases such as HIV/AIDS, tuberculosis, and malaria. Chronic viral hepatitis is caused by hepatitis C virus and hepatitis B virus and these infections are most common in low and middle-income countries, notably Asia and sub-Saharan Africa. In Zambia there are limited data, but from an HIV cohort, the investigators of this study described 10-12% prevalence of chronic HBV. To raise awareness of viral hepatitis in Zambia and to generate local data to guide policymakers, the investigators will recruit 500 adults with chronic HBV infection and follow the cohort in an observational cohort study. In the study patients would be managed according to standards of care and no experimental or investigational drugs would be used. The investigators will carefully describe patient clinical characteristics and among those who receive drug treatment, the investigators will describe the effectiveness of that treatment in reducing liver disease.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • HBV-infected, defined as any single positive HBsAg assay

Exclusion criteria

  • Unable or unwilling to provide informed consent
  • HIV-positive

Treatment and study plan

Standard of care

Other

Routine standard of care per Ministry of Health protocol, including blood draws and examinations.

Primary outcomes

  1. Change in the percentage of patients with HBV viral suppression (Effectiveness of antiviral therapy in HBV-infected patients)

    Time frame: Baseline and after 1 year of treatment

    The percentage of patients with HBV viral suppression.

Secondary outcomes

  1. Proportion of chronic HBV-infected patients with an indication for antiviral treatment.

    Time frame: baseline, after 1 year of treatment, after 2 years of treatment

    Using WHO HBV guidelines, the investigators will determine the proportion of chronic HBV infected patients in the cohort requiring antiviral treatment.

  2. HBV viral control among patients on antiviral treatment

    Time frame: baseline, after 1 year of treatment, after 2 years of treatment

    The percentage of patients with viral control defined as undetectable HBV viral load after 1 and 2 years of treatment.

  3. Serologic, virologic, and hepatic features of chronic HBV infection in Zambia

    Time frame: 0 to month 60

    HBV patients' demographic characteristics at baseline and clinical characteristics at baseline and at 60 months, including alcohol use disorders diagnosed with AUDIT-C, HBV genotypes, HBV viral loads, prevalence of advanced liver disease (based on non-invasive tests), phase of HBV infection (immune tolerant, HBeAg-positive chronic hepatitis, HBeAg-negative chronic hepatitis, and immune control) - based on international guidance.

  4. Proportion with significant liver fibrosis

    Time frame: 0, 12, 24, 36, 48, and 60 months,

    Measure of liver fibrosis using AST-to-platelet ration index (APRI), Fibrosis 4 (FIB-4) and transient elastography.

  5. Incidence and prevalence of hepatocellular carcinoma (HCC)

    Time frame: baseline and after month 60

    The number of new HCC cases (among those without evidence of HCC at baseline) divided by the time in the cohort study.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Centre for Infectious Disease Research in Zambia
  • Tropical Gastroenterology and Nutrition Group

Registry information

Official study title

Chronic Hepatitis B Virus Infection in Zambia: a Prospective Clinical Cohort Study

Acronym: HUTCH

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
May 18, 2017
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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