HBVHUTCHNCT03158818
Chronic Hepatitis B Virus Infection in Zambia
An observational study of HBV and Fibrosis, Liver, run by University of Alabama at Birmingham at 1 site in Zambia.
Trial summary
Chronic hepatitis B virus infection is a common condition in Zambia. Among Zambian blood donors, up to 8% are chronically infected with HBV. Despite the burden, awareness of HBV is low in Zambia and the Ministry of Health is in early stages of development of guidelines for HBV screening, treatment, and prevention. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HBV, Fibrosis, Liver, Cirrhosis, Liver
- How many people
- 326 participants
- Where
- 1 siteZambia
- Study dates
- 23 Aug 2016to 20 Nov 2024
- 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
- Adult, Older adult
Study population: 500 adults with chronic HBV infection
Who may be able to join
- Age 18 years or older
- HBV-infected, defined as any single positive HBsAg assay
Who cannot join
- Unable or unwilling to provide informed consent
- HIV-positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Hepatitis B Virus Infection in Zambia: a Prospective Clinical Cohort Study
Chronic hepatitis B virus infection is a common condition in Zambia. Among Zambian blood donors, up to 8% are chronically infected with HBV. Despite the burden, awareness of HBV is low in Zambia and the Ministry of Health is in early stages of development of guidelines for HBV screening, treatment, and prevention. The purpose of this clinical cohort study is to characterize the clinical features of chronic HBV infection at UTH and describe treatment and care outcomes. The investigators will enroll 500 adults and follow the cohort for up to 5 years to assess short and long-term viral, serologic, and liver outcomes such as cirrhosis and liver cancer.
Read the detailed description
Viral hepatitis is the #7 cause of death worldwide, yet it has been neglected when compared to other infectious diseases such as HIV/AIDS, tuberculosis, and malaria. Chronic viral hepatitis is caused by hepatitis C virus and hepatitis B virus and these infections are most common in low and middle-income countries, notably Asia and sub-Saharan Africa. In Zambia there are limited data, but from an HIV cohort, the investigators of this study described 10-12% prevalence of chronic HBV. To raise awareness of viral hepatitis in Zambia and to generate local data to guide policymakers, the investigators will recruit 500 adults with chronic HBV infection and follow the cohort in an observational cohort study. In the study patients would be managed according to standards of care and no experimental or investigational drugs would be used. The investigators will carefully describe patient clinical characteristics and among those who receive drug treatment, the investigators will describe the effectiveness of that treatment in reducing liver disease.
- Conditions
- HBV, Fibrosis, Liver, Cirrhosis, Liver, Alcoholic Hepatitis, Hepatocellular Carcinoma, Hepatitis, Delta
- Being tested
- Standard of care
- Medical subject headings
- Liver Cirrhosis, Hepatitis, Alcoholic, Carcinoma, Hepatocellular, Hepatitis D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Routine standard of care per Ministry of Health protocol, including blood draws and examinations.
| Study group | Role | What they receive |
|---|---|---|
| HBV mono-infected (Standard of Care) | 500 patients in Zambia Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the percentage of patients with HBV viral suppression (Effectiveness of antiviral therapy in HBV-infected patients)
The percentage of patients with HBV viral suppression.
Measured: Baseline and after 1 year of treatment
Secondary outcomes (5)
Proportion of chronic HBV-infected patients with an indication for antiviral treatment.
Using WHO HBV guidelines, the investigators will determine the proportion of chronic HBV infected patients in the cohort requiring antiviral treatment.
Measured: baseline, after 1 year of treatment, after 2 years of treatment
HBV viral control among patients on antiviral treatment
The percentage of patients with viral control defined as undetectable HBV viral load after 1 and 2 years of treatment.
Measured: baseline, after 1 year of treatment, after 2 years of treatment
Serologic, virologic, and hepatic features of chronic HBV infection in Zambia
HBV patients' demographic characteristics at baseline and clinical characteristics at baseline and at 60 months, including alcohol use disorders diagnosed with AUDIT-C, HBV genotypes, HBV viral loads, prevalence of advanced liver disease (based on non-invasive tests), phase of HBV infection (immune tolerant, HBeAg-positive chronic hepatitis, HBeAg-negative chronic hepatitis, and immune control) - based on international guidance.
Measured: 0 to month 60
Proportion with significant liver fibrosis
Measure of liver fibrosis using AST-to-platelet ration index (APRI), Fibrosis 4 (FIB-4) and transient elastography.
Measured: 0, 12, 24, 36, 48, and 60 months,
Incidence and prevalence of hepatocellular carcinoma (HCC)
The number of new HCC cases (among those without evidence of HCC at baseline) divided by the time in the cohort study.
Measured: baseline and after month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start23 Aug 2016
- Primary completion20 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Tropical Gastroenterology and Nutrition Group, Centre for Infectious Disease Research in 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
- NCT03158818
- Sponsor's protocol ID
- F151224005
- Acronym
- HUTCH
- Status last verified
- Jun 2026
- First submitted
- 8 May 2017
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Franklin S, Mouliom A, Sinkala E, Kanunga A, Helova A, Dionne-Odom J, Turan JM, Vinikoor M. Hepatitis B virus contact disclosure and testing in Lusaka, Zambia: a mixed-methods study. BMJ Open. 2018 Sep 21;8(9):e022522. doi: 10.1136/bmjopen-2018-022522.
PubMed 30244215
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Hepatitis B Virus Infection in Zambia: a Prospective Clinical Cohort Study
- ClinicalTrials.gov ID
- NCT03158818
- Acronym / sponsor ID
- HUTCH / F151224005
- Conditions
- HBV, Fibrosis, Liver, Cirrhosis, Liver, Alcoholic Hepatitis, Hepatocellular Carcinoma, Hepatitis, Delta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Tropical Gastroenterology and Nutrition Group, Centre for Infectious Disease Research in Zambia
- Study start
- 23 Aug 2016 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 18 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.
Chronic hepatitis B virus infection is a common condition in Zambia. Among Zambian blood donors, up to 8% are chronically infected with HBV. Despite the burden, awareness of HBV is low in Zambia and the Ministry of Health is in early stages of development of guidelines for HBV screening, treatment, and prevention. The purpose of this clinical cohort study is to characterize the clinical features of chronic HBV infection at UTH and describe treatment and care outcomes. The investigators will enroll 500 adults and follow the cohort for up to 5 years to assess short and long-term viral, serologic, and liver outcomes such as cirrhosis and liver cancer.
Detailed description
Viral hepatitis is the #7 cause of death worldwide, yet it has been neglected when compared to other infectious diseases such as HIV/AIDS, tuberculosis, and malaria. Chronic viral hepatitis is caused by hepatitis C virus and hepatitis B virus and these infections are most common in low and middle-income countries, notably Asia and sub-Saharan Africa. In Zambia there are limited data, but from an HIV cohort, the investigators of this study described 10-12% prevalence of chronic HBV. To raise awareness of viral hepatitis in Zambia and to generate local data to guide policymakers, the investigators will recruit 500 adults with chronic HBV infection and follow the cohort in an observational cohort study. In the study patients would be managed according to standards of care and no experimental or investigational drugs would be used. The investigators will carefully describe patient clinical characteristics and among those who receive drug treatment, the investigators will describe the effectiveness of that treatment in reducing liver disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBV mono-infected (Standard of Care) | – | Other: Standard of care500 patients in Zambia |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 500 adults with chronic HBV infection
Key inclusion criteria (2 listed)
- Age 18 years or older
- HBV-infected, defined as any single positive HBsAg assay
Key exclusion criteria (2 listed)
- Unable or unwilling to provide informed consent
- HIV-positive
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 |
|---|---|---|
| Standard of careRoutine standard of care per Ministry of Health protocol, including blood draws and examinations. | Other | HBV mono-infected (Standard of Care) |
Primary outcome
Change in the percentage of patients with HBV viral suppression (Effectiveness of antiviral therapy in HBV-infected patients)
Time frame: Baseline and after 1 year of treatment
The percentage of patients with HBV viral suppression.
5 secondary outcomes
Proportion of chronic HBV-infected patients with an indication for antiviral treatment.
Time frame: baseline, after 1 year of treatment, after 2 years of treatment
HBV viral control among patients on antiviral treatment
Time frame: baseline, after 1 year of treatment, after 2 years of treatment
Serologic, virologic, and hepatic features of chronic HBV infection in Zambia
Time frame: 0 to month 60
Proportion with significant liver fibrosis
Time frame: 0, 12, 24, 36, 48, and 60 months,
Incidence and prevalence of hepatocellular carcinoma (HCC)
Time frame: baseline and after month 60
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 12 Jun 2026.
- Derived from this study: PubMed 30244215Franklin S, Mouliom A, Sinkala E, Kanunga A, Helova A, Dionne-Odom J, Turan JM, Vinikoor M. Hepatitis B virus contact disclosure and testing in Lusaka, Zambia: a mixed-methods study. BMJ Open. 2018 Sep 21;8(9):e022522. doi: 10.1136/bmjopen-2018-022522.
- 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 Fibrosis, Liver, 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 12 Jun 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?
Change in the percentage of patients with HBV viral suppression (Effectiveness of antiviral therapy in HBV-infected patients) (time frame: Baseline and after 1 year of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03158818, which also lists 1 linked publication.
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 12 Jun 2026.