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

Alcoholic Hepatitis Clinical Trial

— HEP-ZED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03149627
• Other study ID #: X160524001
• Status: Completed
• Start date: June 7, 2017
• Est. completion date: December 19, 2018

Study information

• Verified date: January 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5003
• Est. completion date: December 19, 2018
• Est. primary completion date: December 19, 2018
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• HBV
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Alcoholic
• Hepatitis, Chronic
• Liver Cirrhosis
• Liver Fibroses

Intervention

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.

Locations

Country	Name	City	State
Zambia	University Teaching Hospital	Lusaka

Sponsors (5)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Centre for Infectious Disease Research in Zambia, Ministry of Health, Zambia, Tropical Gastroenterology and Nutrition Group, University Teaching Hospital

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Frequency of primary drug resistance mutations.	Frequency of primary drug resistance mutations.	within 1 month of part 1
Secondary	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
Secondary	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
Secondary	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
Secondary	HIV prevalence in HBV-patients	HIV prevalence in HBV-patients by self-report or rapid test.	within 1 month of part 1