HBVHEP-ZEDNCT03149627
Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults
An observational study of HBV and Alcoholic Hepatitis, run by University of Alabama at Birmingham at 1 site in Zambia.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HBV, Alcoholic Hepatitis, Liver Fibroses
- What is being tested?
- Estimates - prevalence of lifetime/chronic HBV infection
- How many people
- 5,003 participants
- Where
- 1 siteZambia
- Study dates
- 7 Jun 2017to 19 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Part 1: Unable to provide informed consent
- Part 2: Unwilling to travel to a hospital in their province
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HBV, Alcoholic Hepatitis, Liver Fibroses
- Being tested
- Estimates - prevalence of lifetime/chronic HBV infection
- Medical subject headings
- Hepatitis, Alcoholic, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estimates - prevalence of lifetime/chronic HBV infectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Individuals from selected households | Individuals residing in selected households in Lusaka Province, Zambia. Receives: Other: Estimates - prevalence of lifetime/chronic HBV infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (7)
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.
Measured: within 1 month of part 1
Clinical phenotypes of patients with chronic HBV infection
Determining clinical phenotypes (such as chronic active or inactive) of patients with chronic HBV infection.
Measured: within 1 month of part 1
Frequency of primary drug resistance mutations.
Frequency of primary drug resistance mutations.
Measured: within 1 month of part 1
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.
Measured: within 1 month of part 1
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).
Measured: within 1 month of part 1
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.
Measured: within 1 month of part 1
HIV prevalence in HBV-patients
HIV prevalence in HBV-patients by self-report or rapid test.
Measured: within 1 month of part 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start7 Jun 2017
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Teaching Hospital, Tropical Gastroenterology and Nutrition Group, Centre for Infectious Disease Research in Zambia, Ministry of Health, Zambia
- Responsible party
- Principal investigator, Michael Vinikoor, University of Alabama at Birmingham
- Investigators
- Michael J Vinikoor, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149627
- Sponsor's protocol ID
- X160524001
- Acronym
- HEP-ZED
- Status last verified
- Jan 2019
- First submitted
- 8 May 2017
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults
- ClinicalTrials.gov ID
- NCT03149627
- Acronym / sponsor ID
- HEP-ZED / X160524001
- Conditions
- HBV, Alcoholic Hepatitis, Liver Fibroses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,003 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University Teaching Hospital, Tropical Gastroenterology and Nutrition Group, Centre for Infectious Disease Research in Zambia, Ministry of Health, Zambia
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals from selected households | – | Other: Estimates - prevalence of lifetime/chronic HBV infectionIndividuals residing in selected households in Lusaka Province, Zambia. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Part 1: Unable to provide informed consent
- Part 2: Unwilling to travel to a hospital in their province
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estimates - prevalence of lifetime/chronic HBV infectionEstimation 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. | Other | Individuals from selected households |
Primary outcome
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.
7 secondary outcomes
Proportion of Zambian adults who require antiviral therapy for chronic HBV infection
Time frame: within 1 month of part 1
Clinical phenotypes of patients with chronic HBV infection
Time frame: within 1 month of part 1
Frequency of primary drug resistance mutations.
Time frame: within 1 month of part 1
The proportion of patients with chronic HBV infection who have significant liver fibrosis or cirrhosis.
Time frame: within 1 month of part 1
Unhealthy alcohol use in HBV-positive patients
Time frame: within 1 month of part 1
Hepatosplenic schistosomiasis co-infection with liver fibrosis markers among patients with chronic HBV infection
Time frame: within 1 month of part 1
HIV prevalence in HBV-patients
Time frame: within 1 month of part 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Vinikoor, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HBV and Alcoholic Hepatitis, run by University of Alabama at Birmingham at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and correlates of lifetime HBV infection (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.