Purchase, S;
Batist, E;
Mmile, N;
Nkosi, S;
Workman, J;
Martinson, N;
Fairlie, L;
... Hesseling, AC; + view all
(2021)
Challenges in recruiting children to a multidrug-resistant TB prevention trial.
The International Journal of Tuberculosis and Lung Disease
, 25
(10)
pp. 814-822.
10.5588/ijtld.21.0098.
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Abstract
BACKGROUND: Recruitment to randomised clinical trials can be challenging and slow recruitment has serious consequences. This study aimed to summarise and reflect on the challenges in enrolling young children to a multidrug-resistant TB (MDR-TB) prevention trial in South Africa. METHODS: Recruitment to the Tuberculosis Child Multidrug-resistant Preventive Therapy Trial (TB-CHAMP) was tracked using an electronic recruiting platform, which was used to generate a recruiting flow diagram. Structured personnel questionnaires, meeting minutes and workshop notes were thematically analysed to elucidate barriers and solutions. RESULT: Of 3,682 (85.3%) adult rifampicin (RIF) resistant index cases with pre-screening outcomes, 1597 (43.4%) reported having no children under 5 years in the household and 562 (15.3%) were RIF-monoresistant. More than nine index cases were pre-screened for each child enrolled. Numerous barriers to recruitment were identified. Thorough recruitment planning, customised tracking data systems, a dedicated recruiting team with strong leadership, adequate resources to recruit across large geographic areas, and excellent relationships with routine TB services emerged as key factors to ensure successful recruitment. CONCLUSION: Recruitment of children into MDR-TB prevention trials can be difficult. Several MDR-TB prevention trials are underway, and lessons learnt from TB-CHAMP will be relevant to these and other TB prevention studies.
| Type: | Article |
|---|---|
| Title: | Challenges in recruiting children to a multidrug-resistant TB prevention trial |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.5588/ijtld.21.0098 |
| Publisher version: | https://doi.org/10.5588/ijtld.21.0098 |
| Language: | English |
| Additional information: | This version is the version of record. For information on re-use, please refer to the publisher’s terms and conditions |
| Keywords: | TB-CHAMP; fluoroquinolone; randomised controlled trial |
| 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/10137528 |
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| 2. |  China | 9 |
| 3. |  Russian Federation | 4 |
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| 5. |  Canada | 3 |
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| 7. |  Australia | 2 |
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| 9. |  Germany | 2 |
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