NCT07589985Recruiting
Hep Mec Cohort in Zambia
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
Observational cohort of adults with acute and chronic hepatitis B infection in Zambia, with and without HIV coinfection. Participants join the study at the time of diagnosis and before or at the time when they are starting antiviral treatments and then they are followed up over multiple years to assess changes to their liver and evolution of HBV (and HIV if applicable) infection. All treatments for HBV and HIV are standard per local Ministry of Health guidelines.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 390 (estimated)
- First submitted
- 5 Feb 2026
- Start date
- 28 Sept 2020
- Primary completion date
- 31 Aug 2029
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Hepatitis B, HIV
- NCT number
- NCT07589985
What you commit to
- Study type: Observational
- Planned participants: 390
- From 28 Sept 2020 to the primary completion date, 31 Aug 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kanyama Level 1 Hospital Coordinator of this site? Confirm its status | Lusaka | Zambia | Recruiting |
| University Teaching Hospital Coordinator of this site? Confirm its status | Lusaka | Zambia | Recruiting |
| Matero Level 1 Hospital Coordinator of this site? Confirm its status | Lusaka | Zambia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.