Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586983
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Decentralization of Hepatitis B Care in Sub-Saharan Africa a Pilot Program in Ethiopia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Decentralization of Hepatitis B Care in Sub-Saharan Africa a Pilot Program in Ethiopia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 202122 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 tertiarysecondary 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
In 2015 we set up a pilot treatment program for CHB at a tertiary hospital in Addis Ababa Ethiopia In 202122 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 tertiarysecondary 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None