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
Clinic record review: Routine program data for CLHIV \<12 years or children \<12 years who are household contacts of people living with TB, who are initiated on TPT. \[A household contact is defined as a person who shared the same enclosed living space with the index patient (someone with infectious TB as defined by country guidelines) for one or more nights or for frequent or extended periods during the day during the 3 months before commencement of the current treatment episode.\] Qualitative study: Policy makers, healthcare workers and parents/caregivers will be interviewed - (\>18 years) Clinic-level assessment: Pharmacy managers/pharmacists, procurement and supply management staff - (\>18 years)
Other
Other
Not listed
6
Trial groupsSee each trial group below.
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.
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.
Secondary Objective 1
To quantify the prescription of the new dispersible 3HP vs other regimens among children \<12 years.
Secondary Objective 2
To explore policy makers, healthcare workers and caregivers' insights on different regimens and formulations.
Secondary Objective 3
To assess provider-level barriers and facilitators to delivery of the new dispersible 3HP regimen.
Secondary Objective 4
To determine the impact of the new dispersible 3HP on supply chain and changes needed to accommodate them.
Outcome 1
Any uptake of TPT defined as proportion of eligible children who are initiated on TPT, stratified by regimen
Outcome 2
Proportion of children \<12 years initiated on TPT who complete treatment, stratified by regimen.
Outcome 3
Caregiver experience with and attitudes towards the new dispersible 3HP formulation.
Outcome 4
Barriers and facilitators of the new dispersible 3HP experienced by healthcare workers and policy makers.
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The Aurum Institute NPC
Lead sponsor
Johns Hopkins University
Collaborator
KNCV Tuberculosis Foundation
Collaborator
Clinton Health Access Initiative Inc.
Collaborator
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