Chronic Hepatitis B Virus Infection in Zambia (HUTCH)

June 5, 2025 updated by: Michael Vinikoor, University of Alabama at Birmingham

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

326

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia
        • Tropical Gastroenterology and Nutrition Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

500 adults with chronic HBV infection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HBV mono-infected (Standard of Care)
500 patients in Zambia
Other: Standard of care
Routine standard of care per Ministry of Health protocol, including blood draws and examinations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after 1 year of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, after 1 year of treatment, after 2 years of treatment
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.
baseline, after 1 year of treatment, after 2 years of treatment
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.
0 to month 60
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.
0, 12, 24, 36, 48, and 60 months,
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.
baseline and after month 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

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

Investigators

  • Principal Investigator: Michael J Vinikoor, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2016

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

May 8, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 18, 2017

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F151224005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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