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

NCT03149627 | Completed

• 1 other identifier: X160524001
• Study Type: observational
• Target: 5,003
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HBV; Alcoholic Hepatitis; Liver Fibroses

Outcome Measures

Primary Outcomes (1)

• Prevalence and correlates of lifetime HBV infection

  Estimates 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 in randomly selected households in Lusaka Province in Zambia. Identification of individual (such as age or sex) and community (such as province) correlates of lifetime and chronic HBV infection.

  baseline

Secondary Outcomes (7)

• Proportion of Zambian adults who require antiviral therapy for chronic HBV infection

  within 1 month of part 1

• Clinical phenotypes of patients with chronic HBV infection

  within 1 month of part 1

• Frequency of primary drug resistance mutations.

  within 1 month of part 1

• The proportion of patients with chronic HBV infection who have significant liver fibrosis or cirrhosis.

  within 1 month of part 1

• Unhealthy alcohol use in HBV-positive patients

  within 1 month of part 1

Study Arms (1)

Individuals from selected households

Individuals residing in selected households in Lusaka Province, Zambia.

Other: Estimates - prevalence of lifetime/chronic HBV infection

Interventions

Estimates - prevalence of lifetime/chronic HBV infection 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.

Individuals from selected households

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Part 1: 6,000 individuals residing in randomly selected households in Lusaka Province in Zambia regardless of the clinically health status. Part 2: All part 1 participants who test HBsAg-positive (anticipated sample size of 250) during community testing.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Part 1: The Investigators will test for active HBV infection using a rapid point-of-care HBsAg test. In addition, as a service to clients who have not had an HIV test in the past year (as recommended by Ministry of Health), for 10% of participants (selected randomly at household level), the Investigators will also collect a dried blood spot using finger prick method to perform HBcAb test, an epidemiologic test for lifetime exposure to HBV. Part 2: Participants will have physical examination, a liver ultrasound, transient elastography (TE), and blood will be collected for HBV viral load and other markers.

MeSH Terms

Conditions

Hepatitis, Alcoholic; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: Assistant Professor

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 11, 2017
• Study Start: June 7, 2017
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: January 21, 2026

Record last verified: 2019-01

Locations

ZA (1)