Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults (HEP-ZED)

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.

Study Overview

• Status: Completed
• Conditions: HBV; Alcoholic Hepatitis; Liver Fibroses
• Intervention / Treatment: Other: Estimates - prevalence of lifetime/chronic HBV infection

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 5003

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Individuals from selected households; Individuals residing in selected households in Lusaka Province, Zambia.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Zambian adults who require antiviral therapy for chronic HBV infection	Estimate the proportion of Zambian adults who require antiviral therapy for chronic HBV infection in randomly selected households in Lusaka Province in Zambia.	within 1 month of part 1
Clinical phenotypes of patients with chronic HBV infection	Determining clinical phenotypes (such as chronic active or inactive) of patients with chronic HBV infection.	within 1 month of part 1
Frequency of primary drug resistance mutations.	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.	Estimate the proportion of patients with chronic HBV infection who have significant liver fibrosis or cirrhosis using non-invasive tests.	within 1 month of part 1
Unhealthy alcohol use in HBV-positive patients	Proportion of unhealthy alcohol users measured with the Alcohol Use Disorders Identification Test, and the association of unhealthy alcohol use with liver fibrosis markers among patients with chronic HBV infection. Among participants in part 2 of the study, the Investigators will also describe the prevalence of unhealthy drinking using data from the AUDIT-C screen. The Investigators will categorize patients as 'unhealthy drinkers' if the AUDIT-C score is >3 for men and >2 for women. The Investigators will also assess hepatosplenic schistosomiasis, defined by grade 2 or grade 3 periportal liver fibrosis on abdominal ultrasound. The Investigators will use bivariable and multivariable regression to compare liver fibrosis markers by AUDIT-C score (non/moderate drinkers versus unhealthy drinkers).	within 1 month of part 1
Hepatosplenic schistosomiasis co-infection with liver fibrosis markers among patients with chronic HBV infection	Hepatosplenic schistosomiasis co-infection with liver fibrosis markers among patients with chronic HBV infection. The Investigators will also assess hepatosplenic schistosomiasis, defined by grade 2 or grade 3 periportal liver fibrosis on abdominal ultrasound. The Investigators will use bivariable and multivariable regression to compare liver fibrosis markers by the presence of hepatosplenic schistosomiasis.	within 1 month of part 1
HIV prevalence in HBV-patients	HIV prevalence in HBV-patients by self-report or rapid test.	within 1 month of part 1

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Centre for Infectious Disease Research in Zambia; Ministry of Health, Zambia; University Teaching Hospital; Tropical Gastroenterology and Nutrition Group
• Investigators: Principal Investigator: Michael J Vinikoor, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2017
• Primary Completion (Actual): December 19, 2018
• Study Completion (Actual): December 19, 2018

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 12, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Fibrosis; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Liver Cirrhosis; Hepatitis, Alcoholic
• Other Study ID Numbers: X160524001

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