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NCT Number: NCT06511180

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

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.

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Key information

Conditions

TB - Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Children, Only Gram-Positive Bacterial Infections HIV Household Contact Infections Latent Infection Latent Tuberculosis Mycobacterium Infections Tuberculosis

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Clinic record review

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.

Treatment and study plan

Primary outcomes

  1. Overarching Objective

    Time frame: 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.

  2. Primary Objective 1

    Time frame: 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 outcomes

  1. Secondary Objective 1

    Time frame: 18 months

    To quantify the prescription of the new dispersible 3HP vs other regimens among children <12 years.

  2. Secondary Objective 2

    Time frame: 18 months

    To explore policy makers, healthcare workers and caregivers' insights on different regimens and formulations.

  3. Secondary Objective 3

    Time frame: 18 months

    To assess provider-level barriers and facilitators to delivery of the new dispersible 3HP regimen.

  4. Secondary Objective 4

    Time frame: 18 months

    To determine the impact of the new dispersible 3HP on supply chain and changes needed to accommodate them.

Other outcomes

  1. Outcome 1

    Time frame: 18 months

    Any uptake of TPT defined as proportion of eligible children who are initiated on TPT, stratified by regimen

  2. Outcome 2

    Time frame: 18 months

    Proportion of children <12 years initiated on TPT who complete treatment, stratified by regimen.

  3. Outcome 3

    Time frame: 18 months

    Caregiver experience with and attitudes towards the new dispersible 3HP formulation.

  4. Outcome 4

    Time frame: 18 months

    Barriers and facilitators of the new dispersible 3HP experienced by healthcare workers and policy makers.

  5. Outcome 5

    Time frame: 18 months

    Logistics and supply chain issues related to country level procurement, forecasting and distribution to clinic level for the dispersible 3HP.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Mukora

CONTACT

[email protected]

+27 (0) 83 784 3107

Violet Chihota

CONTACT

[email protected]

+27 (0) 82 319 1559

Sponsors and collaborators

Lead sponsor

The Aurum Institute NPC

Other

Collaborators

  • Clinton Health Access Initiative Inc.
  • Johns Hopkins University
  • KNCV Tuberculosis Foundation

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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