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

NCT06511180 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2024-07-19

No results posted yet for this study

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.

Conditions

  • TB - Tuberculosis
  • Household Contact
  • HIV
  • Children, Only

Sponsors & Collaborators

  • Johns Hopkins University

    collaborator OTHER

  • KNCV Tuberculosis Foundation

    collaborator OTHER

  • Clinton Health Access Initiative Inc.

    collaborator OTHER

  • The Aurum Institute NPC

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2025-06-30
Completion
2025-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06511180 on ClinicalTrials.gov