NCT06586983

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Sep 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Sep 2024Sep 2028

First Submitted

Initial submission to the registry

September 4, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

September 4, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2028

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 years

First QC Date

September 4, 2024

Last Update Submit

September 7, 2024

Conditions

Hepatitis B

Keywords

Liver cirrhosisAntiviral agentsLiver diseaseResource-limited settings

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Secondary Outcomes (4)

  • Linkage to care

    3 years

  • Loss to follow-up

    3 years

  • Viral suppression

    3 years

  • HIV incidence

    3 years

Study Arms (3)

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

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.

Drug: Tenofovir Disoproxil Fumarate

Test-and-treat model ("treat all")

All HBsAg positive patients will receive treatment.

Drug: Tenofovir Disoproxil Fumarate

Interventions

Tenofovir Disoproxil FumarateDRUG

300 mg po OD

Inclusive model ("treat all except")Standard model ("treat only if")Test-and-treat model ("treat all")

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adults with a positive HBsAg rapid test are eligible for inclusion.

You may qualify if:

  • Adult (at least 18 years of age) who is HBsAg positive.

You may not qualify if:

  • Below 18 years of age.
  • Negative HBsAg rapid test at screening visit.
  • Other disease with short life expectancy (disseminated cancer etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addis Ababa University

Addis Ababa, Addis Ababa, Ethiopia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dried blood spots

MeSH Terms

Conditions

Hepatitis BLiver CirrhosisLiver Diseases

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Asgeir Johannessen, MD PhD

    The Hospital of Vestfold

    STUDY DIRECTOR

  • Nega Berhe, MD PhD

    Addis Ababa University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asgeir Johannessen, MD PhD

CONTACT

+4797983264johannessen.asgeir@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher / project manager

Study Record Dates

First Submitted

September 4, 2024

First Posted

September 19, 2024

Study Start

September 4, 2024

Primary Completion (Estimated)

September 5, 2028

Study Completion (Estimated)

September 5, 2028

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

ET(1)