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Acceptability of a first-line anti-tuberculosis formulation for children: qualitative data from the SHINE trial

D T Wademan1, L Busakwe1, T J Nicholson1

  • 1Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg, South Africa.

The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease
|January 15, 2020
PubMed

Insights

A new fixed-dose combination (FDC) tuberculosis drug is acceptable for children, though caregivers faced challenges with administration. Further support is recommended for successful scale-up of this pediatric TB treatment.

Area of Science:

  • Pediatric infectious diseases
  • Pharmacology and drug development
  • Qualitative health research

Background:

  • Tuberculosis (TB) treatment in children requires palatable and easy-to-administer formulations.
  • Fixed-dose combinations (FDCs) offer advantages in simplifying multi-drug regimens.
  • The SHINE trial evaluates shorter TB treatment durations for children.

Purpose of the Study:

  • To assess the palatability and acceptability of a novel fixed-dose combination (FDC) anti-tuberculosis drug.
  • To explore the experiences of children and caregivers with administering and ingesting the FDC.
  • To identify challenges and facilitators for FDC use in pediatric TB treatment.

Main Methods:

  • Qualitative study nested within the SHINE trial in Cape Town, South Africa.
  • 20 clinic observations of treatment administration.
  • 16 semi-structured interviews with children and caregivers.

Main Results:

  • Experiences with the FDC ranged from positive to negative.
  • Participants generally found the FDC preferable to other formulations.
  • Challenges included dissolving the FDC and time constraints for administration, leading to drug manipulation.

Conclusions:

  • The novel FDC demonstrates acceptability among pediatric TB patients.
  • Practical challenges in administration require attention for successful implementation.
  • Supplementary interventions are needed to support caregivers for wider FDC scale-up.

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