Randomised controlled trial to evaluate the effectiveness of using the RD-1-based C-Tb skin test as a replacement for blood-based interferon-γ release assay for detection of, and initiation of preventive treatment for, tuberculosis infection: RID-TB:Dx study protocol
Introduction The predictive utility for incident tuberculosis (TB) of the purified protein derivative tuberculin skin test and region of difference 1 (RD1)-based interferon-gamma release assays (IGRA) is comparable; and either is recommended to test for latent TB infection (LTBI). Despite associated...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2021-12-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/12/e050595.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850259824383623168 |
|---|---|
| author | Marc Lipman Ibrahim Abubakar Chris Griffiths Penny Whiting Robert Horne Alex Ghanouni Heinke Kunst Mike Mandelbaum Molebogeng X Rangaka Karen Sanders Peter J White Angela Crook Dominik Zenner Trinh Duong Vanessa Hack Julian Surey Yohhei Hamada Henry Bern Joanna Calvert Marie Francis Amy Louise Clarke Ellen Owen-Powell Helen L Booth |
| author_facet | Marc Lipman Ibrahim Abubakar Chris Griffiths Penny Whiting Robert Horne Alex Ghanouni Heinke Kunst Mike Mandelbaum Molebogeng X Rangaka Karen Sanders Peter J White Angela Crook Dominik Zenner Trinh Duong Vanessa Hack Julian Surey Yohhei Hamada Henry Bern Joanna Calvert Marie Francis Amy Louise Clarke Ellen Owen-Powell Helen L Booth |
| author_sort | Marc Lipman |
| collection | DOAJ |
| description | Introduction The predictive utility for incident tuberculosis (TB) of the purified protein derivative tuberculin skin test and region of difference 1 (RD1)-based interferon-gamma release assays (IGRA) is comparable; and either is recommended to test for latent TB infection (LTBI). Despite associated high costs of IGRA, sites participating in LTBI screening in many high-income settings pragmatically favour IGRA due to its higher specificity and simpler logistics. A new RD1-based skin test, C-Tb, could offer an acceptable and as accurate, cheaper alternative to IGRA. Evaluating the impact of C-Tb on process and patient-related outcomes would provide important information to help guide its use in LTBI testing strategies.Methods and analysis This is a pragmatic multicentre, open-label, non-inferiority, randomised controlled trial. The trial will assess the initiation of LTBI treatment following a positive result of the randomised test as the primary outcome. Participants will be randomised to receive the C-Tb test (intervention) or IGRA (usual care, control) for initiation of treatment. We will enrol 1530 participants in England aged≥16 years who are eligible for LTBI testing and treatment according to UK guidance. In the C-Tb arm, skin induration will be assessed 2–3 days after intradermal injection and measured in millimetres of induration. Results of IGRA will be obtained in line with standard practice. Behavioural studies will explore people’s experiences, perspectives and preferences of LTBI testing and treatment. Economic analysis will estimate cost-effectiveness of changes to the diagnostic algorithm for LTBI. The protocol was developed with Patient and Public Involvement (PPI), which will continue throughout the trial.Ethics and dissemination Ethics approval has been obtained from The NHS Health Research Authority (269485). We will share results of the trial in peer-reviewed journals and conferences.Trial registration number EudraCT 2019-002592-34; ISRCTN17936038. |
| format | Article |
| id | doaj-art-feec39c7a93341439aecf67ddde581fd |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-feec39c7a93341439aecf67ddde581fd2025-08-20T01:55:46ZengBMJ Publishing GroupBMJ Open2044-60552021-12-01111210.1136/bmjopen-2021-050595Randomised controlled trial to evaluate the effectiveness of using the RD-1-based C-Tb skin test as a replacement for blood-based interferon-γ release assay for detection of, and initiation of preventive treatment for, tuberculosis infection: RID-TB:Dx study protocolMarc Lipman0Ibrahim Abubakar1Chris Griffiths2Penny Whiting3Robert Horne4Alex Ghanouni5Heinke Kunst6Mike Mandelbaum7Molebogeng X Rangaka8Karen Sanders9Peter J White10Angela Crook11Dominik Zenner12Trinh Duong13Vanessa Hack14Julian Surey15Yohhei Hamada16Henry Bern17Joanna Calvert18Marie Francis19Amy Louise Clarke20Ellen Owen-Powell21Helen L Booth22Royal Free London Hospital NHS Foundation Trust, London, UKInstitute of Global Health, University College London, London, UKCentre for Primary Care and Public Health, Queen Mary University of London, London, UKassociate professor of clinical epidemiology7 UCL School of Pharmacy, University College London, London, UKCentre for Behavioural Medicine, UCL School of Pharmacy, London, UKBlizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UKTB Alert, London, UKInstitute for Global Health, University College London, London, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UKModelling and Economics Unit, Public Health England, London, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK13 Queen Mary University of London, London, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UKInstitute for Global Health, University College London, London, UKInstitute for Global Health, University College London, London, UKInstitute for Global Health, University College London, London, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UKInstitute for Global Health, University College London, London, UKCentre for Behavioural Medicine, UCL School of Pharmacy, London, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UKhonorary consultant thoracic physicianIntroduction The predictive utility for incident tuberculosis (TB) of the purified protein derivative tuberculin skin test and region of difference 1 (RD1)-based interferon-gamma release assays (IGRA) is comparable; and either is recommended to test for latent TB infection (LTBI). Despite associated high costs of IGRA, sites participating in LTBI screening in many high-income settings pragmatically favour IGRA due to its higher specificity and simpler logistics. A new RD1-based skin test, C-Tb, could offer an acceptable and as accurate, cheaper alternative to IGRA. Evaluating the impact of C-Tb on process and patient-related outcomes would provide important information to help guide its use in LTBI testing strategies.Methods and analysis This is a pragmatic multicentre, open-label, non-inferiority, randomised controlled trial. The trial will assess the initiation of LTBI treatment following a positive result of the randomised test as the primary outcome. Participants will be randomised to receive the C-Tb test (intervention) or IGRA (usual care, control) for initiation of treatment. We will enrol 1530 participants in England aged≥16 years who are eligible for LTBI testing and treatment according to UK guidance. In the C-Tb arm, skin induration will be assessed 2–3 days after intradermal injection and measured in millimetres of induration. Results of IGRA will be obtained in line with standard practice. Behavioural studies will explore people’s experiences, perspectives and preferences of LTBI testing and treatment. Economic analysis will estimate cost-effectiveness of changes to the diagnostic algorithm for LTBI. The protocol was developed with Patient and Public Involvement (PPI), which will continue throughout the trial.Ethics and dissemination Ethics approval has been obtained from The NHS Health Research Authority (269485). We will share results of the trial in peer-reviewed journals and conferences.Trial registration number EudraCT 2019-002592-34; ISRCTN17936038.https://bmjopen.bmj.com/content/11/12/e050595.full |
| spellingShingle | Marc Lipman Ibrahim Abubakar Chris Griffiths Penny Whiting Robert Horne Alex Ghanouni Heinke Kunst Mike Mandelbaum Molebogeng X Rangaka Karen Sanders Peter J White Angela Crook Dominik Zenner Trinh Duong Vanessa Hack Julian Surey Yohhei Hamada Henry Bern Joanna Calvert Marie Francis Amy Louise Clarke Ellen Owen-Powell Helen L Booth Randomised controlled trial to evaluate the effectiveness of using the RD-1-based C-Tb skin test as a replacement for blood-based interferon-γ release assay for detection of, and initiation of preventive treatment for, tuberculosis infection: RID-TB:Dx study protocol BMJ Open |
| title | Randomised controlled trial to evaluate the effectiveness of using the RD-1-based C-Tb skin test as a replacement for blood-based interferon-γ release assay for detection of, and initiation of preventive treatment for, tuberculosis infection: RID-TB:Dx study protocol |
| title_full | Randomised controlled trial to evaluate the effectiveness of using the RD-1-based C-Tb skin test as a replacement for blood-based interferon-γ release assay for detection of, and initiation of preventive treatment for, tuberculosis infection: RID-TB:Dx study protocol |
| title_fullStr | Randomised controlled trial to evaluate the effectiveness of using the RD-1-based C-Tb skin test as a replacement for blood-based interferon-γ release assay for detection of, and initiation of preventive treatment for, tuberculosis infection: RID-TB:Dx study protocol |
| title_full_unstemmed | Randomised controlled trial to evaluate the effectiveness of using the RD-1-based C-Tb skin test as a replacement for blood-based interferon-γ release assay for detection of, and initiation of preventive treatment for, tuberculosis infection: RID-TB:Dx study protocol |
| title_short | Randomised controlled trial to evaluate the effectiveness of using the RD-1-based C-Tb skin test as a replacement for blood-based interferon-γ release assay for detection of, and initiation of preventive treatment for, tuberculosis infection: RID-TB:Dx study protocol |
| title_sort | randomised controlled trial to evaluate the effectiveness of using the rd 1 based c tb skin test as a replacement for blood based interferon γ release assay for detection of and initiation of preventive treatment for tuberculosis infection rid tb dx study protocol |
| url | https://bmjopen.bmj.com/content/11/12/e050595.full |
| work_keys_str_mv | AT marclipman randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT ibrahimabubakar randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT chrisgriffiths randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT pennywhiting randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT roberthorne randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT alexghanouni randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT heinkekunst randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT mikemandelbaum randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT molebogengxrangaka randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT karensanders randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT peterjwhite randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT angelacrook randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT dominikzenner randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT trinhduong randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT vanessahack randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT juliansurey randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT yohheihamada randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT henrybern randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT joannacalvert randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT mariefrancis randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT amylouiseclarke randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT ellenowenpowell randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol AT helenlbooth randomisedcontrolledtrialtoevaluatetheeffectivenessofusingtherd1basedctbskintestasareplacementforbloodbasedinterferongreleaseassayfordetectionofandinitiationofpreventivetreatmentfortuberculosisinfectionridtbdxstudyprotocol |