Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children: a Multi-country Evaluation

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.

NCT Number	NCT06511180
Lead Sponsor	The Aurum Institute NPC Collaborators: Johns Hopkins University, KNCV Tuberculosis Foundation, Clinton Health Access Initiative Inc.
Conditions	TB - Tuberculosis, Household Contact, HIV, Children, Only
Enrollment	1,200 participants
Start Date	2024-08
Primary Completion	2025-06 (estimated)
Study Completion	2025-06 (estimated)
Updated on ClinicalTrials.gov	2024-07-19