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.
Study Type
OBSERVATIONAL
Enrollment
1,200
Overarching Objective
The overarching goal of the evaluation is to generate critical knowledge to improve delivery of TPT and, more specifically, of dispersible 3HP, in children in routine programs.
Time frame: 18 months
Primary Objective 1
To quantify the TPT care cascade from identification, screening, eligibility, treatment initiation to completion among children \<12 years of age, stratified by regimen.
Time frame: 18 months
Secondary Objective 1
To quantify the prescription of the new dispersible 3HP vs other regimens among children \<12 years.
Time frame: 18 months
Secondary Objective 2
To explore policy makers, healthcare workers and caregivers' insights on different regimens and formulations.
Time frame: 18 months
Secondary Objective 3
To assess provider-level barriers and facilitators to delivery of the new dispersible 3HP regimen.
Time frame: 18 months
Secondary Objective 4
To determine the impact of the new dispersible 3HP on supply chain and changes needed to accommodate them.
Time frame: 18 months
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