Integrating Hepatitis B Elimination Into the HIV Program in Zambia

NCT07875218 — Not applicable, Enrolling by invitation, 460 participants, Centre for Infectious Disease Research in Zambia

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Integrating Hepatitis B Elimination Into the HIV Program in Zambia: Developing and Piloting a New Model of Care

RegistryNCT07875218, acronym INTEGRATE B
StatusEnrolling by invitation
PhaseNot applicable
Study typeInterventional; non randomized, crossover, masking: none, health services research
Enrollment460 (Estimated)
SponsorCentre for Infectious Disease Research in Zambia (Other); collaborators: The Task Force for Global Health
ConditionsHepatitis B, HIV, Implementation Science
InterventionsIntegrated HBV/HIV Service Delivery Model (Other)
Datesstart 2026-07-21, primary completion 2028-06-30 (estimated), completion 2029-03-31 (estimated), first posted 2026-10-15, last updated 2026-10-15
Locations1 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

-Summary

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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Integrated HBV/HIV Service ModelOtherOther: Integrated HBV/HIV Service Delivery ModelA co-designed HBV/HIV service delivery intervention
ControlActive comparatorOther: Integrated HBV/HIV Service Delivery ModelSites initially in this arm will not receive an integrated HBV/HIV service delivery package, but will crossover in Year 3.
  • Integrated HBV/HIV Service Delivery Model (Other): This intervention encompasses a package which will include training, HBV screening campaigns and HBV vaccination campaigns.

+Outcome measures

Primary outcomes

  • Implementation Outcome [Six-months post-intervention]: Pilot will be evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework

Other outcomes

  • Acceptability [Six-months post-intervention]: Perception among stakeholders (e.g. clinic staff, patients) that the model is agreeable, satisfactory, worth using
  • Completion of the integrated HBV-HIV service package (Feasibility) [Six-months post-intervention]: 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.
  • Adoption [Six-months post-intervention]: Uptake and initial use of the innovation by the target provider
  • Reach [Six-months post-intervention]: Primary reach outcome will be defined as the proportion of the target population that HBV screening.
  • Fidelity [Six-months post-intervention]: Degree to which the intervention is delivered as intended by its protocol
  • Cost [Six-months post-intervention]: Incremental cost of implementation with the integrated HBV model

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Centre for Infectious Disease Research in ZambiaLusaka, Lusaka ProvinceZambia