Clinical trial · Observational
Chronic Hepatitis B Virus Infection in Zambia
Chronic Hepatitis B Virus Infection in Zambia: a Prospective Clinical Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alcoholic Hepatitis | — | UNRESOLVED | — |
| Cirrhosis, Liver | — | UNRESOLVED | — |
| Fibrosis, Liver | — | UNRESOLVED | — |
| HBV | — | UNRESOLVED | — |
| Hepatitis, Delta | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HBV mono-infected (Standard of Care)
- description
- 500 patients in Zambia
- interventionNames
- Other: Standard of care
Primary outcomes (1)
- measure
- Change in the percentage of patients with HBV viral suppression (Effectiveness of antiviral therapy in HBV-infected patients)
- timeFrame
- Baseline and after 1 year of treatment
- description
- The percentage of patients with HBV viral suppression.
Secondary outcomes (5)
- measure
- Proportion of chronic HBV-infected patients with an indication for antiviral treatment.
- timeFrame
- baseline, after 1 year of treatment, after 2 years of treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * HBV-infected, defined as any single positive HBsAg assay Exclusion Criteria: * Unable or unwilling to provide informed consent * HIV-positive
References
Publications (1)
- DERIVEDFranklin 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. PMID 30244215