Acceptability of a first-line anti-tuberculosis formulation for children: qualitative data from the SHINE trial
OBJECTIVE: To describe the palatability and acceptability of a FDC of rifampicin, isoniazid and pyrazinamide among South African children and their caregivers in the SHINE trial.
METHODS: We conducted 20 clinic observations of treatment administration, during which we conducted 16 semi-structured interviews with children and their caregivers. Data were organised thematically to report on experiences with administering and ingesting the FDC.
RESULTS: Children and caregivers' experiences varied from delight to disgust. In general, participants said that the FDC compared favourably to other formulations. Pragmatic challenges such as dissolving the FDC and the time required to administer the FDC impeded caregivers' ability to integrate treatment into their daily routines. Drug manipulation was common among caregivers to improve TB treatment administration.
CONCLUSION: This novel FDC appears acceptable for children, albeit with practical challenges to administration. Scale-up of FDC use should include supplementary intervention components to support caregivers.
Keywords: TB; acceptability; paediatric; palatability, fixed-dose combination formulations
Document Type: Research Article
Affiliations: 1: Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg, South Africa 2: Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology, London 3: Department of Global Health, London School of Hygiene & Tropical Medicine, London, UK
Publication date: 01 December 2019
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