Wademan, DT;
Busakwe, L;
Nicholson, TJ;
van der Zalm, M;
Palmer, M;
Workman, J;
Turkova, A;
... Hoddinott, G; + view all
(2019)
Acceptability of a first-line anti-tuberculosis formulation for children: qualitative data from the SHINE trial.
International Journal of Tuberculosis and Lung Disease
, 23
(12)
pp. 2363-2368.
10.5588/ijtld.19.0115.
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Abstract
SETTING: We conducted a qualitative exploration into the palatability and acceptability of a novel fixed-dose combination (FDC) anti-tuberculosis drug. This study was nested in the SHINE (Shorter treatment for minimal TB in children) trial, which compares the safety and efficacy of treating non-severe drug-susceptible tuberculosis (TB) with a 6 vs. 4 months anti-tuberculosis regimen in children aged 0–16 years. Participants were recruited in Cape Town, South Africa. 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.
| Type: | Article |
|---|---|
| Title: | Acceptability of a first-line anti-tuberculosis formulation for children: qualitative data from the SHINE trial |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.5588/ijtld.19.0115 |
| Publisher version: | https://doi.org/10.5588/ijtld.19.0115 |
| Language: | English |
| Additional information: | This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
| Keywords: | TB; acceptability; paediatric; palatability, fixed-dose combination formulations |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10088833 |
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