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.
Medical records of children <12 years who are either CLHIV or who are household contacts of people with pulmonary TB and who are initiated on TPT
Records will be excluded for children who are contacts of a drug-resistant, have presumptive TB disease or are currently on TB treatment
Adult caregiver (>18 years) of a child <12 years of age who is eligible for TPT
Healthcare worker from one of the clinics in which the study will be conducted who sees outpatient pediatric consultations including TB-exposed children
Policy maker or program manager who manages or is involved in PMTCT, TB and/or pediatric programming
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Trial groupsSee each trial group below.
The Aurum Institute NPC
Lead sponsor
Johns Hopkins University
Collaborator
KNCV Tuberculosis Foundation
Collaborator
Clinton Health Access Initiative Inc.
Collaborator