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Completed

NCT Number: NCT03149627

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

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Teaching Hospital

Lusaka, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Prevalence and correlates of lifetime HBV infection

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Clinical phenotypes of patients with chronic HBV infection

    Time frame: within 1 month of part 1

    Determining clinical phenotypes (such as chronic active or inactive) of patients with chronic HBV infection.

  3. Frequency of primary drug resistance mutations.

    Time frame: within 1 month of part 1

    Frequency of primary drug resistance mutations.

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

    Time frame: 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.

  5. Unhealthy alcohol use in HBV-positive patients

    Time frame: 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).

  6. Hepatosplenic schistosomiasis co-infection with liver fibrosis markers among patients with chronic HBV infection

    Time frame: 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.

  7. HIV prevalence in HBV-patients

    Time frame: within 1 month of part 1

    HIV prevalence in HBV-patients by self-report or rapid test.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Centre for Infectious Disease Research in Zambia
  • Ministry of Health, Zambia
  • Tropical Gastroenterology and Nutrition Group
  • University Teaching Hospital

Registry information

Acronym: HEP-ZED

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 11, 2017
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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