Hep Mec Cohort in Zambia
Hep Mec
5 other identifiers
observational
390
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2020
CompletedFirst Submitted
Initial submission to the registry
February 5, 2026
CompletedFirst Posted
Study publicly available on registry
May 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2030
May 15, 2026
January 1, 2026
8.9 years
February 5, 2026
May 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Intrahepatic Immune Cell Subset Frequencies
Percentage of immune cell subsets (CD4+ T cells, CD8+ T cells, B cells, NK cells, Macrophages, and Neutrophils) among total liver immune cells as measured by single-cell RNA sequencing. Comparisons will be made between acute and chronic HBV infection, with and without HIV coinfection, and before and after nucleoside analog antiviral therapy.
Baseline and 1 year
Number of Differentially Expressed Hepatic Genes Associated with HBsAg Reduction/Loss
Count of genes showing differential expression (fold change ≥2.0, adjusted p-value \<0.05) by single-cell RNA sequencing in liver biopsies from participants achieving HBsAg loss compared to those without HBsAg loss. Gene expression will be analyzed at baseline (predictive analysis), longitudinally (trajectory analysis), and at end of follow-up. Analysis will include comparison across acute vs. chronic HBV infection and with vs. without HIV coinfection.
Baseline and 1 year
Secondary Outcomes (4)
HBV viral suppression
Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
HIV viral suppression
Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
HBsAg seroclearance
Through study completion, an average of 5 years
HBeAg seroconversion
Through study completion, an average of 5 years
Study Arms (5)
Treatment-naive chronic HBV monoinfection and eligible for antiviral therapy
Adults who are HBsAg-positive, HIV-positive, eligible for HBV antiviral therapy and has not yet or just started taking therapy
Treatment-naive acute HBV monoinfection
Adults who are HBsAg-positive, HIV-negative, and have the syndrome of acute hepatitis
Treatment-naive HBV/HIV coinfection
Adults who are both HBsAg and HIV positive, and are not yet or just started taking HBV-active ART
Treatment-experienced HBV/HIV coinfection with persistent HBsAg-emia
Adults with HBV/HIV coinfection and persistent HBsAg-emia after at least 4 years of HBV-active ART
Treatment-experienced HBV infection with HBsAg loss
Adults with and without HIV coinfection who have a documented history of chronic HBV infection that subsequently resolved (i.e., HBsAg loss) during antiviral therapy
Eligibility Criteria
This study will occur in Lusaka, Zambia, which has 12% adult HIV prevalence and \~4% adult HBsAg-positivity. Both HIV and HBV treatment are free and provided through the Ministry of Health. Tenofovir-based therapies are used for HBV monoinfection and HBV/HIV coinfection. Potential participants will be recruited from Ministry of Health (i.e., public sector) clinics at study sites including from a pool of participants in past HBV research projects. There are a 5 groups of participants we seek to enroll in the study, to facilitate addressing the scientific goals of the cohort.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Centre for Infectious Disease Research in Zambiacollaborator
- Tropical Gastroenterology and Nutrition Groupcollaborator
- University of Zambiacollaborator
- Massachusetts General Hospitalcollaborator
- Weill Medical College of Cornell Universitycollaborator
Study Sites (3)
Kanyama Level 1 Hospital
Lusaka, Zambia
Matero Level 1 Hospital
Lusaka, Zambia
University Teaching Hospital
Lusaka, Zambia
Related Publications (5)
Vinikoor MJ, Hamusonde K, Muula G, Asombang M, Riebensahm C, Chitundu H, Sunkuntu-Sichizya V, Bhattacharya D, Sinkala E, Lauer G, Chung R, Mbewe W, Egger M, Bosomprah S, Wandeler G. Long-term Hepatitis B and Liver Outcomes Among Adults Taking Tenofovir-Containing Antiretroviral Therapy for HBV/HIV Coinfection in Zambia. Clin Infect Dis. 2024 Jun 14;78(6):1583-1590. doi: 10.1093/cid/ciad654.
PMID: 37997691BACKGROUNDChihota BV, Wandeler G, Chilengi R, Mulenga L, Chung RT, Bhattacharya D, Egger M, Vinikoor MJ. High Rates of Hepatitis B Virus (HBV) Functional Cure Among Human Immunodeficiency Virus-HBV Coinfected Patients on Antiretroviral Therapy in Zambia. J Infect Dis. 2020 Jan 2;221(2):218-222. doi: 10.1093/infdis/jiz450.
PMID: 31613956BACKGROUNDMuula GK, Bosomprah S, Sinkala E, Nsokolo B, Musonda T, Hamusonde K, Bhattacharya D, Lauer G, Chung RT, Mulenga LB, Wandeler G, Vinikoor MJ. Hepatitis B viral replication markers and hepatic fibrosis in untreated chronic hepatitis B virus infection with and without HIV coinfection in Zambia. AIDS. 2023 Nov 1;37(13):2015-2020. doi: 10.1097/QAD.0000000000003659. Epub 2023 Jul 17.
PMID: 37467044BACKGROUNDVinikoor MJ, Walker A, Nsokolo B, Musonda T, Muula G, Michailidis E, Wandeler G, Alatrakchi N, Kelly P, Damagnez M, Le DB, Voges A, Lubke N, Kanunga A, Bosomprah S, Bhattacharya D, Chibundi C, Bwalya G, Musukuma-Chifulo K, Suslov A, Feuerherd M, Heim MH, Schwartz RE, Chung RT, Lauer G, Sinkala E, Timm J. Whole-Genome Sequencing of Hepatitis B Virus Genotypes E and A in Zambia Reveals Limited Viral Diversity in HIV Coinfection. Open Forum Infect Dis. 2025 Oct 1;12(11):ofaf616. doi: 10.1093/ofid/ofaf616. eCollection 2025 Nov.
PMID: 41200694RESULTMusonda T, Wallace MS, Patel H, Martin OP, Oetheimer C, Mwakamui S, Sinkala E, Nsokolo B, Kanunga A, Lauer G, Chung RT, Wandeler G, Bhattacharya D, Kelly P, Alatrakchi N, Vinikoor MJ. New Window Into Hepatitis B in Africa: Liver Sampling Combined With Single-Cell Omics Enables Deep and Longitudinal Assessment of Intrahepatic Immunity in Zambia. J Infect Dis. 2024 Nov 15;230(5):e1171-e1175. doi: 10.1093/infdis/jiae054.
PMID: 38332750RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Vinikoor, MD
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
February 5, 2026
First Posted
May 15, 2026
Study Start
September 28, 2020
Primary Completion (Estimated)
August 31, 2029
Study Completion (Estimated)
August 31, 2030
Last Updated
May 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Supporting information will be made available at study completion. IPD will be made available after completion of primary outcome analyses. We expect primary outcomes analyses will be completed in 2027, 2028, and 2029.
- Access Criteria
- During the study, only staff in Zambia and collaborating investigators will have access to IPD and supporting information. After the end of the study, this will be gradually made publicly available.
All study results and anonymized participant data will be made publicly-available. The timing will be based on when analysis is completed and results are disseminated. The study also will adhere to Zambian laws around data protection and sharing.