Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children: a Multi-country Evaluation
NCT ID: NCT06511180
Last Updated: 2024-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1200 participants
OBSERVATIONAL
2024-08-31
2025-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Children <12 years who are eligible for TPT - HHC
No intervention. Clinic record review: Data will be retrospectively abstracted from routine medical files using a standardised data collection tool that will document TPT uptake and outcomes
No interventions assigned to this group
Policy makers/Program managers
No intervention. Qualitative study: We will recruit a purposive sample of policy makers, healthcare workers and caregivers who will be interviewed to evaluate buy-in and explore their insights and experiences on the different TPT regimens and formulations.
No interventions assigned to this group
Healthcare Workers
No intervention. Qualitative study: We will recruit a purposive sample of policy makers, healthcare workers and caregivers who will be interviewed to evaluate buy-in and explore their insights and experiences on the different TPT regimens and formulations.
No interventions assigned to this group
Caregivers
No intervention. Qualitative study: We will recruit a purposive sample of policy makers, healthcare workers and caregivers who will be interviewed to evaluate buy-in and explore their insights and experiences on the different TPT regimens and formulations.
No interventions assigned to this group
Pharmacy managers/pharmacists
No intervention. Clinic assessment: We will assess provider barriers and facilitators to prescribing the new dispersible 3HP (single dispersible formulations of isoniazid and rifapentine) through a survey tool which will collect information on the flow of TPT from national supply to the clinic and dispensing to the child.
No interventions assigned to this group
Procurement managers/Supply managers
No intervention. Clinic assessment: We will assess provider barriers and facilitators to prescribing the new dispersible 3HP (single dispersible formulations of isoniazid and rifapentine) through a survey tool which will collect information on the flow of TPT from national supply to the clinic and dispensing to the child.
No interventions assigned to this group
Eligibility Criteria
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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
Qualitative study
* 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.
ALL
Yes
Sponsors
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Johns Hopkins University
OTHER
KNCV Tuberculosis Foundation
OTHER
Clinton Health Access Initiative Inc.
OTHER
The Aurum Institute NPC
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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ERC.0004119
Identifier Type: OTHER
Identifier Source: secondary_id
AUR2-7-428
Identifier Type: -
Identifier Source: org_study_id
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