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Trial record 91 of 309 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
Verified June 2017 by Michael Vinikoor, University of Alabama at Birmingham
Sponsor:
ClinicalTrials.gov Identifier:
NCT03149627
First Posted: May 11, 2017
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University Teaching Hospital
Tropical Gastroenterology and Nutrition Group
Centre for Infectious Disease Research in Zambia
Ministry of Health, Zambia
Information provided by (Responsible Party):
Michael Vinikoor, University of Alabama at Birmingham
  Purpose
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.

Condition Intervention
HBV Alcoholic Hepatitis Liver Fibroses Other: Estimates - prevalence of lifetime/chronic HBV infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults

Resource links provided by NLM:


Further study details as provided by Michael Vinikoor, University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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 Southern and Luapula Provinces 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:
  • 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 Southern and Luapula Provinces in Zambia.

  • 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.

  • Frequency of primary drug resistance mutations. [ Time Frame: within 1 month of part 1 ]
    Frequency of primary drug resistance mutations.

  • 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.

  • 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).

  • 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.

  • HIV prevalence in HBV-patients [ Time Frame: within 1 month of part 1 ]
    HIV prevalence in HBV-patients by self-report or rapid test.


Biospecimen Retention:   Samples Without DNA

Part 1: The Investigators will test for active HBV infection using a rapid point-of-care HBsAg test. In addition, as a service to clients who have not had an HIV test in the past year (as recommended by Ministry of Health), for 20% of participants (selected randomly at household level), the Investigators will also collect a dried blood spot using finger prick method to perform HBcAb test, an epidemiologic test for lifetime exposure to HBV.

Part 2: Participants will have physical examination, a liver ultrasound, transient elastography (TE), and blood will be collected for HBV viral load and other markers.


Estimated Enrollment: 6000
Actual Study Start Date: June 7, 2017
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Individuals from selected households
Individuals residing in selected households in Northern/Luapula 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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

Part 1: 6,000 individuals residing in randomly selected households in Northern and Luapula Provinces 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 .

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149627


Contacts
Contact: Michael J Vinikoor, MD 260966921285 mjv3@uab.edu

Locations
Zambia
University Teaching Hospital Recruiting
Lusaka, Zambia
Contact: Michael J Vinikoor, MD    260966921285    mjv3@uab.edu   
Sub-Investigator: Edford Sinkala         
Sub-Investigator: Paul Kelly         
Sub-Investigator: Callistus Kaayunga         
Sub-Investigator: Bright Nsokolo         
Sponsors and Collaborators
University of Alabama at Birmingham
University Teaching Hospital
Tropical Gastroenterology and Nutrition Group
Centre for Infectious Disease Research in Zambia
Ministry of Health, Zambia
Investigators
Principal Investigator: Michael J Vinikoor, MD University of Alabama at Birmingham
  More Information

Responsible Party: Michael Vinikoor, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03149627     History of Changes
Other Study ID Numbers: X160524001
First Submitted: May 8, 2017
First Posted: May 11, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Alcoholic
Hepatitis, Viral, Human
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders