Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia

Sponsor
Oslo University Hospital
Study ID
NCT06586983
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tenofovir Disoproxil Fumarate — DRUG
    300 mg po OD

Study Details

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.

Key Dates

First listed
Sep 19, 2024
Start date
Sep 4, 2024
Status verified
Sep 2024
Primary completion
Sep 5, 2028
Completion
Sep 5, 2028

Study Design

Enrollment
4,500 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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.
  • Arm: Test-and-treat model ("treat all")
    All HBsAg positive patients will receive treatment.

Primary Outcome Measure

Death or liver decompensation [ Time Frame: 3 years ]

Central Contacts

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