Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult (at least 18 years of age) who is HBsAg positive.
Locations
Other Locations
Ethiopia
Addis Ababa University
RECRUITING
Addis Ababa
Contact Information
Primary
Asgeir Johannessen, MD PhD
johannessen.asgeir@gmail.com
+4797983264
Time Frame
Start Date: 2024-09-04
Estimated Completion Date: 2028-09-05
Participants
Target number of participants: 4500
Treatments
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
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.
Test-and-treat model (treat all)
All HBsAg positive patients will receive treatment.
Related Therapeutic Areas
Sponsors
Collaborators: Norges Forskningsråd, Stenberggata 26, pb. 2700, N-0131 Oslo, Norway, Sykehuset i Vestfold HF, Addis Ababa University, St. Paul's Hospital Millennium Medical College, Ethiopia
Leads: Oslo University Hospital