Chronic Hepatitis B Virus Infection in Zambia

NCT03158818 | Completed

• 1 other identifier: F151224005
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HBV; Fibrosis, Liver; Cirrhosis, Liver; Alcoholic Hepatitis; Hepatocellular Carcinoma; Hepatitis, Delta

Outcome Measures

Primary Outcomes (1)

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

  The percentage of patients with HBV viral suppression.

  Baseline and after 1 year of treatment

Secondary Outcomes (5)

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

  baseline, after 1 year of treatment, after 2 years of treatment

• HBV viral control among patients on antiviral treatment

  baseline, after 1 year of treatment, after 2 years of treatment

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

  0 to month 60

• Proportion with significant liver fibrosis

  0, 12, 24, 36, 48, and 60 months,

• Incidence and prevalence of hepatocellular carcinoma (HCC)

  baseline and after month 60

Study Arms (1)

HBV mono-infected (Standard of Care)

500 patients in Zambia

Other: Standard of care

Interventions

Standard of care OTHER

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

HBV mono-infected (Standard of Care)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

500 adults with chronic HBV infection

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Tropical Gastroenterology and Nutrition Group: collaborator
• Centre for Infectious Disease Research in Zambia: collaborator

Study Sites (1)

Tropical Gastroenterology and Nutrition Group

Lusaka, Zambia

Location

Related Publications (1)

• Franklin S, Mouliom A, Sinkala E, Kanunga A, Helova A, Dionne-Odom J, Turan JM, Vinikoor M. Hepatitis B virus contact disclosure and testing in Lusaka, Zambia: a mixed-methods study. BMJ Open. 2018 Sep 21;8(9):e022522. doi: 10.1136/bmjopen-2018-022522.

  PMID: 30244215 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood collected (up to 15 mL) from a vein in the arm for various tests related to HBV and general health at each visit

MeSH Terms

Conditions

Liver Cirrhosis; Hepatitis, Alcoholic; Carcinoma, Hepatocellular; Hepatitis D

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michael J Vinikoor, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 18, 2017
• Study Start: August 23, 2016
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

ZA (1)