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

Completed

• Conditions: HBV; Alcoholic Hepatitis; Liver Fibroses
• Interventions: Other: Estimates - prevalence of lifetime/chronic HBV infection

• Registration Number: NCT03149627
• Lead Sponsor: University of Alabama at Birmingham

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.

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 Timeline

• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Study Start: 2017-06-07
• Primary Completion: 2018-12-19
• Study Completion: 2018-12-19
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-12
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5003

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals from selected households	Estimates - prevalence of lifetime/chronic HBV infection	Individuals residing in selected households in Lusaka Province, Zambia.

Primary Outcome Measures

Name	Time	Method
Prevalence and correlates of lifetime HBV infection	baseline	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Zambian adults who require antiviral therapy for chronic HBV infection	within 1 month of part 1	Estimate the proportion of Zambian adults who require antiviral therapy for chronic HBV infection in randomly selected households in Lusaka Province in Zambia.
Frequency of primary drug resistance mutations.	within 1 month of part 1	Frequency of primary drug resistance mutations.
Clinical phenotypes of patients with chronic HBV infection	within 1 month of part 1	Determining clinical phenotypes (such as chronic active or inactive) of patients with chronic HBV infection.
The proportion of patients with chronic HBV infection who have significant liver fibrosis or cirrhosis.	within 1 month of part 1	Estimate the proportion of patients with chronic HBV infection who have significant liver fibrosis or cirrhosis using non-invasive tests.
Hepatosplenic schistosomiasis co-infection with liver fibrosis markers among patients with chronic HBV infection	within 1 month of part 1	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.
Unhealthy alcohol use in HBV-positive patients	within 1 month of part 1	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).
HIV prevalence in HBV-patients	within 1 month of part 1	HIV prevalence in HBV-patients by self-report or rapid test.

Trial Locations

Locations (1)

University Teaching Hospital; 🇿🇲 Lusaka, Zambia