Hepatitis BINTEGRATE BNCT07875218
Integrating Hepatitis B Elimination Into the HIV Program in Zambia
A study testing Integrated HBV/HIV Service Delivery Model in people with Hepatitis B and HIV, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, HIV, Implementation Science
- What is being tested?
- Integrated HBV/HIV Service Delivery Model
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteZambia
- Study dates
- 21 Jul 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- None
- Client participants:
- The person was NOT enrolled in the Hep-Mec study and NOT enrolled in the Liver Fibrosis study irrespective of screening status
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zambia1 site
Centre for Infectious Disease Research in Zambia
Lusaka, Lusaka Province
About this study
Official title: Integrating Hepatitis B Elimination Into the HIV Program in Zambia: Developing and Piloting a New Model of Care
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.
Read the 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.
- Conditions
- Hepatitis B, HIV, Implementation Science
- Being tested
- Integrated HBV/HIV Service Delivery Model
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated HBV/HIV Service Delivery ModelOther
This intervention encompasses a package which will include training, HBV screening campaigns and HBV vaccination campaigns.
| Study group | Role | What they receive |
|---|---|---|
| Integrated HBV/HIV Service Model | Other | A co-designed HBV/HIV service delivery intervention Receives: Other: Integrated HBV/HIV Service Delivery Model |
| Control | Active comparator | Sites initially in this arm will not receive an integrated HBV/HIV service delivery package, but will crossover in Year 3. Receives: Other: Integrated HBV/HIV Service Delivery Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation Outcome
Pilot will be evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework
Measured: Six-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start21 Jul 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- The Task Force for Global Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875218
- Sponsor's protocol ID
- REF No. 8057-2026 INTEGRATE B
- Acronym
- INTEGRATE B
- Status last verified
- Oct 2026
- First submitted
- 23 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Hepatitis B Elimination Into the HIV Program in Zambia: Developing and Piloting a New Model of Care
- ClinicalTrials.gov ID
- NCT07875218
- Acronym / sponsor ID
- INTEGRATE B / REF No. 8057-2026 INTEGRATE B
- Conditions
- Hepatitis B, HIV, Implementation Science
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Collaborators
- The Task Force for Global Health
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated HBV/HIV Service Model | Other | Other: Integrated HBV/HIV Service Delivery ModelA co-designed HBV/HIV service delivery intervention |
| Control | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (3 listed)
- None
- The person was NOT enrolled in the Hep-Mec study and NOT enrolled in the Liver Fibrosis study irrespective of screening status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated HBV/HIV Service Delivery ModelThis intervention encompasses a package which will include training, HBV screening campaigns and HBV vaccination campaigns. | Other | Control, Integrated HBV/HIV Service Model |
Primary outcome
Implementation Outcome
Time frame: Six-months post-intervention
Pilot will be evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated HBV/HIV Service Delivery Model in people with Hepatitis B and HIV, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation Outcome (time frame: Six-months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.