Hepatitis BNCT06586983
Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia
An observational study of Hepatitis B, run by Oslo University Hospital at 1 site in Ethiopia.
Trial summary
The goal of this observational study is to study models of care for decentralized hepatitis B treatment in Ethiopia. Three different models of decentralized HBV care (standard model, simplified model, test-and-treat model) will be implemented at primary hospitals or health clinics in Ethiopia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Tenofovir Disoproxil Fumarate
- Type of treatment
- Injection or infusion
- How many people
- 4,500 participants
- Where
- 1 siteEthiopia
- Study dates
- 4 Sep 2024to 5 Sep 2028
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All adults with a positive HBsAg rapid test are eligible for inclusion.
Who may be able to join
- Adult (at least 18 years of age) who is HBsAg positive.
Who cannot join
- Below 18 years of age.
- Negative HBsAg rapid test at screening visit.
- Other disease with short life expectancy (disseminated cancer etc.)
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to study models of care for decentralized hepatitis B treatment in Ethiopia.
Three different models of decentralized HBV care (standard model, simplified model, test-and-treat model) will be implemented at primary hospitals or health clinics in Ethiopia. Treatment will be given for free to patients who meet the treatment criteria. We will compare clinical outcome, laboratory outcomes and programmatic outcome measures between the 3 models.
Read the detailed description
Chronic hepatitis B (CHB) is a major health problem globally, and in Ethiopia 5-10 % of the general population are infected with hepatitis B. In the absence of treatment, 15-40 % of these will die from its complications. Antiviral therapy effectively prevents disease progression and death in CHB. However, In low-income countries antiviral treatment is rarely available due to complex treatment guidelines, poor laboratory capacity, restrictions on antiviral treatment and lack of public funding.
In 2015, we set up a pilot treatment program for CHB at a tertiary hospital in Addis Ababa, Ethiopia. In 2021/22, this program was extended to four regional secondary hospitals to study simplified CHB care in a low-income country. With the present study we aim to decentralize CHB therapy to rural settings, which will be essential to achieve universal access to antiviral therapy in Africa. We will study different treatment models, each of which has its theoretical pros and cons: i) standard model ("treat only if…"), ii) inclusive model ("treat all except…"), and iii) test-and-treat ("treat all"). The primary endpoint will be death or liver decompensation, and secondary endpoints will be programmatic and laboratory success indicators. Moreover, we will study the cost-effectiveness of these decentralized models and compare with the tertiary/secondary hospital-based model.
Implementation research, such as our study, is of vital importance to respond to the research gaps identified by the World Health Organization in hepatitis B care. Our study is expected to directly inform international hepatitis B guidelines and will be a major contribution to the efforts to eliminate viral hepatitis as a public health threat by 2030.
- Conditions
- Hepatitis B
- Being tested
- Tenofovir Disoproxil Fumarate
- Keywords
- Liver cirrhosis, Antiviral agents, Liver disease, Resource-limited settings
- Medical subject headings
- Hepatitis B, Liver Cirrhosis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil FumarateDrug
300 mg po OD
| Study group | Role | What they receive |
|---|---|---|
| Standard model ("treat only if") | HBsAg positive patients will be eligible for treatment of they fulfill one of the following criteria:
i) Clinically diagnosed cirrhosis; or ii) APRI ≥0.5; or iii) Persistently elevated ALT >40 U/L; or iv) Co-infection with HCV or HDV; or v) Family history of HCC/cirrhosis; or vi) Relevant co-morbidity Receives: Drug: Tenofovir Disoproxil Fumarate | |
| Inclusive model ("treat all except") | HBsAg positive patients will receive treatment, except if APRI ≤0.3 and no clinical signs/symptoms of cirrhosis and no risk factors for liver disease. Receives: Drug: Tenofovir Disoproxil Fumarate | |
| Test-and-treat model ("treat all") | All HBsAg positive patients will receive treatment. Receives: Drug: Tenofovir Disoproxil Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or liver decompensation
Deaths will be verified by tracing patients who miss appointments. Liver decompensation will be detected clinically and with liver function test assessed every 6-12 months.
Measured: 3 years
Secondary outcomes (4)
Linkage to care
Proportion of HBsAg positive patients on community screening that are linked to treatment center.
Measured: 3 years
Loss to follow-up
Proportion of patients lost from care despite attempts of tracing patients who misses appointments.
Measured: 3 years
Viral suppression
Proportion of patients with viral suppression, measured by HBV DNA test after 3 years in patients who receive treatment.
Measured: 3 years
HIV incidence
Proportion of patients with deteced HIV infection during the 3 year follow-up.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Sep 2024
- Primary completion5 Sep 2028 (estimated)
- Study completion5 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norges Forskningsråd, Stenberggata 26, pb. 2700, N-0131 Oslo, Norway, Addis Ababa University, Sykehuset i Vestfold HF, St. Paul's Hospital Millennium Medical College, Ethiopia
- Responsible party
- Principal investigator, Asgeir Johannessen, The Hospital of Vestfold
- Investigators
- Asgeir Johannessen, MD PhD, Study director, The Hospital of VestfoldNega Berhe, MD PhD, Principal investigator, Addis Ababa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586983
- Sponsor's protocol ID
- 656480
- Status last verified
- Oct 2026
- First submitted
- 4 Sep 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We don\'t intend to share IPD beyond our study group. However, the consent form describes sharing of IPD and we might consider this in the future if there are good scientific rationale to do so.
Publications
Malme KB, Berhe N, Hunduma F, Desalegn H, Johannessen A. Decentralization of hepatitis B care in sub-Saharan Africa: study protocol for a prospective cohort assessing three models of care in rural Ethiopia. BMC Health Serv Res. 2025 Sep 30;25(1):1223. doi: 10.1186/s12913-025-13340-1.
PubMed 41029661
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia
- ClinicalTrials.gov ID
- NCT06586983
- Acronym / sponsor ID
- 656480
- Conditions
- Hepatitis B
- Keywords
- Liver cirrhosis, Antiviral agents, Liver disease, Resource-limited settings
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norges Forskningsråd, Stenberggata 26, pb. 2700, N-0131 Oslo, Norway, Addis Ababa University, Sykehuset i Vestfold HF, St. Paul's Hospital Millennium Medical College, Ethiopia
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 5 Sep 2028 (estimated)
- Study completion
- 5 Sep 2028 (estimated)
- First posted
- 19 Sep 2024 (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 observational study is to study models of care for decentralized hepatitis B treatment in Ethiopia.
Three different models of decentralized HBV care (standard model, simplified model, test-and-treat model) will be implemented at primary hospitals or health clinics in Ethiopia. Treatment will be given for free to patients who meet the treatment criteria. We will compare clinical outcome, laboratory outcomes and programmatic outcome measures between the 3 models.
Detailed description
Chronic hepatitis B (CHB) is a major health problem globally, and in Ethiopia 5-10 % of the general population are infected with hepatitis B. In the absence of treatment, 15-40 % of these will die from its complications. Antiviral therapy effectively prevents disease progression and death in CHB. However, In low-income countries antiviral treatment is rarely available due to complex treatment guidelines, poor laboratory capacity, restrictions on antiviral treatment and lack of public funding.
In 2015, we set up a pilot treatment program for CHB at a tertiary hospital in Addis Ababa, Ethiopia. In 2021/22, this program was extended to four regional secondary hospitals to study simplified CHB care in a low-income country. With the present study we aim to decentralize CHB therapy to rural settings, which will be essential to achieve universal access to antiviral therapy in Africa. We will study different treatment models, each of which has its theoretical pros and cons: i) standard model ("treat only if…"), ii) inclusive model ("treat all except…"), and iii) test-and-treat ("treat all"). The primary endpoint will be death or liver decompensation, and secondary endpoints will be programmatic and laboratory success indicators. Moreover, we will study the cost-effectiveness of these decentralized models and compare with the tertiary/secondary hospital-based model.
Implementation research, such as our study, is of vital importance to respond to the research gaps identified by the World Health Organization in hepatitis B care. Our study is expected to directly inform international hepatitis B guidelines and will be a major contribution to the efforts to eliminate viral hepatitis as a public health threat by 2030.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard model ("treat only if") | – | Drug: Tenofovir Disoproxil FumarateHBsAg positive patients will be eligible for treatment of they fulfill one of the following criteria: i) Clinically diagnosed cirrhosis; or ii) APRI ≥0.5; or iii) Persistently elevated ALT >40 U/L; or iv) Co-infection with HCV or HDV; or v) Family history of HCC/cirrhosis; or vi) Relevant co-morbidity |
| Inclusive model ("treat all except") | – | Drug: Tenofovir Disoproxil FumarateHBsAg positive patients will receive treatment, except if APRI ≤0.3 and no clinical signs/symptoms of cirrhosis and no risk factors for liver disease. |
| Test-and-treat model ("treat all") | – | Drug: Tenofovir Disoproxil FumarateAll HBsAg positive patients will receive treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults with a positive HBsAg rapid test are eligible for inclusion.
Key inclusion criteria (1 listed)
- Adult (at least 18 years of age) who is HBsAg positive.
Key exclusion criteria (3 listed)
- Below 18 years of age.
- Negative HBsAg rapid test at screening visit.
- Other disease with short life expectancy (disseminated cancer etc.)
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 |
|---|---|---|
| Tenofovir Disoproxil Fumarate300 mg po OD | Drug | Inclusive model ("treat all except"), Standard model ("treat only if"), Test-and-treat model ("treat all") |
Primary outcome
Death or liver decompensation
Time frame: 3 years
Deaths will be verified by tracing patients who miss appointments. Liver decompensation will be detected clinically and with liver function test assessed every 6-12 months.
4 secondary outcomes
Linkage to care
Time frame: 3 years
Loss to follow-up
Time frame: 3 years
Viral suppression
Time frame: 3 years
HIV incidence
Time frame: 3 years
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 20 Oct 2026.
- Derived from this study: PubMed 41029661Malme KB, Berhe N, Hunduma F, Desalegn H, Johannessen A. Decentralization of hepatitis B care in sub-Saharan Africa: study protocol for a prospective cohort assessing three models of care in rural Ethiopia. BMC Health Serv Res. 2025 Sep 30;25(1):1223. doi: 10.1186/s12913-025-13340-1.
- Individual participant dataSharing planned: Undecided. We don\'t intend to share IPD beyond our study group. However, the consent form describes sharing of IPD and we might consider this in the future if there are good scientific rationale to do so.
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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. This study is not recruiting at the moment.
Asgeir Johannessen, MD PhD study director
The Hospital of Vestfold
Nega Berhe, MD PhD principal investigator
Addis Ababa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Oslo University Hospital at 1 site in Ethiopia.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 20 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 Ethiopia. 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?
Death or liver decompensation (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06586983, which also lists 1 linked publication.
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 20 Oct 2026.