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

Not yet recruiting

• Conditions: HIV; Children, Only; TB - Tuberculosis; Household Contact

• Registration Number: NCT06511180
• Lead Sponsor: The Aurum Institute NPC

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-16
• Study First Posted: 2024-07-19
• Last Update Posted: 2024-07-19
• Study Start: 2024-08
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• 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

Exclusion Criteria

• Records will be excluded for children who are contacts of a drug-resistant, have presumptive TB disease or are currently on TB treatment

Qualitative study

Inclusion Criteria:

• 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

Exclusion Criteria:

• Any adult caregivers, healthcare workers, policy makers or program managers who are unable or unwilling to provide informed consent for both the interview and audio-recording.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overarching Objective	18 months	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	18 months	To quantify the TPT care cascade from identification, screening, eligibility, treatment initiation to completion among children \<12 years of age, stratified by regimen.

Secondary Outcome Measures

Name	Time	Method
Secondary Objective 3	18 months	To assess provider-level barriers and facilitators to delivery of the new dispersible 3HP regimen.
Secondary Objective 2	18 months	To explore policy makers, healthcare workers and caregivers' insights on different regimens and formulations.
Secondary Objective 1	18 months	To quantify the prescription of the new dispersible 3HP vs other regimens among children \<12 years.
Secondary Objective 4	18 months	To determine the impact of the new dispersible 3HP on supply chain and changes needed to accommodate them.