Clinical trial NCT03149627: Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults
Official title: Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HBV
Alcoholic Hepatitis
Liver Fibroses
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University Teaching Hospital
name: Tropical Gastroenterology and Nutrition Group
name: Centre for Infectious Disease Research in Zambia
name: Ministry of Health, Zambia
First posted: 2017-05-11
Enrollment: 5003
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence and correlates of lifetime HBV infection
timeFrame: baseline
Secondary outcomes:
measure: Proportion of Zambian adults who require antiviral therapy for chronic HBV infection
timeFrame: within 1 month of part 1
measure: Clinical phenotypes of patients with chronic HBV infection
timeFrame: within 1 month of part 1
measure: Frequency of primary drug resistance mutations.
timeFrame: within 1 month of part 1
measure: The proportion of patients with chronic HBV infection who have significant liver fibrosis or cirrhosis.
timeFrame: within 1 month of part 1
measure: Unhealthy alcohol use in HBV-positive patients
timeFrame: within 1 month of part 1
measure: Hepatosplenic schistosomiasis co-infection with liver fibrosis markers among patients with chronic HBV infection
timeFrame: within 1 month of part 1
measure: HIV prevalence in HBV-patients
timeFrame: within 1 month of part 1
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael J Vinikoor, MD
role: PRINCIPAL_INVESTIGATOR
References: