Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511180
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children a Multi-country Evaluation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children a Multi-country Evaluation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 WHO has recommended TB preventive therapy TPT for children living with HIV CLHIV and household contacts of people living with TB however the scale-up and implementation of TPT has been sub-optimal globally particularly in children A safe and effective short-course TPT regimen 3HP rifapentine and isoniazid given once weekly for three months is available but there is a lack of child-friendly formulations resulting in increased pill burden and there is a need to improve acceptability and adherence among children The introduction of a dispersible rifapentine formulation has potential to improve uptake treatment adherence and completion
Overall goal is to generate critical knowledge to improve delivery of TPT and more specifically of dispersible 3HP in children in routine programs
This evaluation will create an important understanding of TPT uptake and completion among children and assess the impact of the introduction of a dispersible 3HP formulation These results will provide actionable information for improving service delivery and the scale-up of TPT in the respective countries
Overall goal is to generate critical knowledge to improve delivery of TPT and more specifically of dispersible 3HP in children in routine programs
This evaluation will create an important understanding of TPT uptake and completion among children and assess the impact of the introduction of a dispersible 3HP formulation These results will provide actionable information for improving service delivery and the scale-up of TPT in the respective countries
Detailed Description:
None
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