An observational study in HBV, Fibrosis, Liver and Cirrhosis, Liver, sponsored by University of Alabama at Birmingham. Completed at 1 site in Zambia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by University of Alabama at Birmingham · Observational
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.
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.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's enrollment of 326 is above the median of 171 across 526 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
500 adults with chronic HBV infection
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
500 patients in Zambia
Other: Standard of care
Routine standard of care per Ministry of Health protocol, including blood draws and examinations.
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.
Time frame: Baseline and after 1 year of treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and after month 60
Plan to share: Undecided
Ran from Aug 2016 to primary completion in Nov 2024, 98 months.
Of 231 non-industry observational studies under Liver Cirrhosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's 98 months is above that.
Counting every sponsor, half of 247 studies reached it within 47 months; a quarter within 18 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Alabama at Birmingham →