Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children: a Multi-country Evaluation
NCT Number: NCT06511180
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: TB - Tuberculosis|Household Contact|HIV|Children, Only
Sponsor: The Aurum Institute NPC
Collaborators: Johns Hopkins University|KNCV Tuberculosis Foundation|Clinton Health Access Initiative Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-06

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.

Primary Outcome Measures: 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., 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., 18 months
Secondary Outcome Measures: Secondary Objective 1, To quantify the prescription of the new dispersible 3HP vs other regimens among children \<12 years., 18 months|Secondary Objective 2, To explore policy makers, healthcare workers and caregivers' insights on different regimens and formulations., 18 months|Secondary Objective 3, To assess provider-level barriers and facilitators to delivery of the new dispersible 3HP regimen., 18 months|Secondary Objective 4, To determine the impact of the new dispersible 3HP on supply chain and changes needed to accommodate them., 18 months
Other Outcome Measures: Outcome 1, Any uptake of TPT defined as proportion of eligible children who are initiated on TPT, stratified by regimen, 18 months|Outcome 2, Proportion of children \<12 years initiated on TPT who complete treatment, stratified by regimen., 18 months|Outcome 3, Caregiver experience with and attitudes towards the new dispersible 3HP formulation., 18 months|Outcome 4, Barriers and facilitators of the new dispersible 3HP experienced by healthcare workers and policy makers., 18 months|Outcome 5, Logistics and supply chain issues related to country level procurement, forecasting and distribution to clinic level for the dispersible 3HP., 18 months