Hepatitis B in Zambia: an observational cohort of adults with HBV, with or without HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study observes adults diagnosed with acute or chronic hepatitis B in Zambia, including those with HIV coinfection. Participants enroll at diagnosis or before/at the start of antiviral therapy and are followed for multiple years to track liver health and the natural history of HBV, with HIV management aligned to local guidelines. No experimental interventions are introduced; treatments follow standard Ministry of Health recommendations. The study aims to understand disease progression, the effect of coinfection, and long-term outcomes in this setting. Key subgroups include individuals on or naive to tenofovir-based therapy and those with various HBV/HIV combinations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Must meet the inclusion criteria for one of 5 groups, as follows:

* Group 1 (rx-naive chronic hbv mono): 18+ years old, HBsAg-positive, HIV-negative, eligible for tenofovir-based therapy, reports taking therapy no more than 7 days (could have previously taken if has stopped \>1 year ago).
* Group 2 (acute hbv mono): 18+ years old, HBsAg-positive, HIV-negative, acute/subacute onset of hepatitis signs and symptoms and ALT \>10 times upper limit of normal
* Group 3 (rx-naive hbv/hiv coinfection): 18+ years old, HBsAg-positive, HIV-negative, eligible for tenofovir-based therapy, reports taking therapy no more than 7 days (could have previously taken if has stopped \>1 year ago).
* Group 4 (rx-experienced coinfection with hbv persistence): 18+ years old, history of chronic HBV infection based on two tests 6 months apart, HIV-positive, at least 4 years of tenofovir-based antiviral therapy, currently HBsAg-positive
* Group 5 (hbsag loss): 18+ years old, HIV-positive or negative, history of chronic HBV infection based on two tests 6 months apart, Currently HBsAg-negative confirmed by sensitive assay

Exclusion Criteria:

* Hepatitis C coinfection (antibody-positive and RNA-positive), current or recent (past 6 weeks) pregnancy, decompensated cirrhosis on physical examination, unlikely to remain in Lusaka for study duration

Where it's running

• Kanyama Level 1 Hospital
  Lusaka, Zambia Recruiting
• Matero Level 1 Hospital
  Lusaka, Zambia Recruiting
• University Teaching Hospital
  Lusaka, Zambia Recruiting

Study contacts

• Principal investigator: Michael Vinikoor, MD — University of Alabama at Birmingham
• Study coordinator: Michael J Vinikoor, MD
• Email: mjv3@uab.edu
• Phone: 205-934-5191

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.