An interventional study of Integrated HBV/HIV Service Delivery Model in Hepatitis B, HIV and Implementation Science, sponsored by Centre for Infectious Disease Research in Zambia. Enrolling by invitation at 1 site in Zambia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Centre for Infectious Disease Research in Zambia · Not applicable, Interventional, and Health services research
The goal of this study is to develop an integrated HBV-HIV service care model in Zambia by working with people living with HBV, healthcare workers, policy makers and other key stakeholders to co-design an intervention.
The study aims to develop and test a practical way of integrating hepatitis B (HBV) services into existing HIV care services in Zambia. It will first work with people living with HBV, healthcare workers, policymakers, and other stakeholders to understand current challenges and co-design an integrated HBV-HIV care model. The model will then be piloted in selected health facilities in Lusaka Province.
The study will assess whether the integrated model is acceptable, feasible, effective, and sustainable, with particular attention to HBV screening, linkage to care, treatment, health worker capacity, and service delivery. The findings will provide evidence to help the Ministry of Health determine how HBV services can be integrated into HIV programmes and potentially scaled up nationally.
1,662 studies on the registry are indexed under Hepatitis B; 192 are open to participants now.
This study's planned enrollment of 460 is above the median of 120 across 1,191 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Centre for Infectious Disease Research in Zambia is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthcare Workers:
Inclusion Criteria:
Exclusion Criteria:
Client participants:
Inclusion Criteria:
Exclusion Criteria:
- The person was NOT enrolled in the Hep-Mec study and NOT enrolled in the Liver Fibrosis study irrespective of screening status
A co-designed HBV/HIV service delivery intervention
Other: Integrated HBV/HIV Service Delivery Model
Sites initially in this arm will not receive an integrated HBV/HIV service delivery package, but will crossover in Year 3.
Other: Integrated HBV/HIV Service Delivery Model
This intervention encompasses a package which will include training, HBV screening campaigns and HBV vaccination campaigns.
Implementation Outcome
Pilot will be evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework
Time frame: Six-months post-intervention
Acceptability
Perception among stakeholders (e.g. clinic staff, patients) that the model is agreeable, satisfactory, worth using
Time frame: Six-months post-intervention
Completion of the integrated HBV-HIV service package (Feasibility)
Percentage of enrolled participants who receive all services required by the study protocol, such as HIV testing or treatment review, hepatitis B surface antigen testing, clinical assessment, referral, and treatment or vaccination when indicated.
Time frame: Six-months post-intervention
Adoption
Uptake and initial use of the innovation by the target provider
Time frame: Six-months post-intervention
Reach
Primary reach outcome will be defined as the proportion of the target population that HBV screening.
Time frame: Six-months post-intervention
Fidelity
Degree to which the intervention is delivered as intended by its protocol
Time frame: Six-months post-intervention
Cost
Incremental cost of implementation with the integrated HBV model
Time frame: Six-months post-intervention
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jun 2028, 23 months after the start.
Of 86 non-industry interventional studies with no phase under Hepatitis B, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 23 months is below that.
Counting every sponsor, half of 95 studies reached it within 30 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Centre for Infectious Disease Research in Zambia