Integrating Hepatitis B Elimination Into the HIV Program in Zambia: Developing and Piloting a New Model of Care
| Registry | NCT07875218, acronym INTEGRATE B |
|---|---|
| Status | Enrolling by invitation |
| Phase | Not applicable |
| Study type | Interventional; non randomized, crossover, masking: none, health services research |
| Enrollment | 460 (Estimated) |
| Sponsor | Centre for Infectious Disease Research in Zambia (Other); collaborators: The Task Force for Global Health |
| Conditions | Hepatitis B, HIV, Implementation Science |
| Interventions | Integrated HBV/HIV Service Delivery Model (Other) |
| Dates | start 2026-07-21, primary completion 2028-06-30 (estimated), completion 2029-03-31 (estimated), first posted 2026-10-15, last updated 2026-10-15 |
| Locations | 1 site in Zambia |
Related Papers Related Patents Related Grants Related Experts
All trials for Hepatitis B All trials for HIV All trials of Integrated HBV/HIV Service Delivery Model
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Integrated HBV/HIV Service Model | Other | Other: Integrated HBV/HIV Service Delivery Model | A co-designed HBV/HIV service delivery intervention |
| Control | Active comparator | 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. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Healthcare Workers: Inclusion Criteria: * Age 18 years and above * Work (provide services) at the 4 facilities across various cadres (both lay and professional) * Have been working at facility for at least 6 months Exclusion Criteria: * None Client participants: Inclusion Criteria: * Age 18 years and above * Received at least one HBV-related service at the facility including but not limited to testing, enrollment for HBV care, and HBV antiviral medicines * They consider the facility their medical home * If HBV-positive are willing to stay in care at the same facility Exclusion Criteria: \- The person was NOT enrolled in the Hep-Mec study and NOT enrolled in the Liver Fibrosis study irrespective of screening status
| Facility | City | Country | Status |
|---|---|---|---|
| Centre for Infectious Disease Research in Zambia | Lusaka, Lusaka Province | Zambia |