Evaluating the effect of short-course rifapentine-based regimens with or without enhanced behaviour-targeted treatment support on adherence and completion of treatment for latent tuberculosis infection among adults in the UK (RID-TB: Treat): protocol for an open-label, multicentre, randomised controlled trial
Introduction The successful scale-up of a latent tuberculosis (TB) infection testing and treatment programme is essential to achieve TB elimination. However, poor adherence compromises its therapeutic effectiveness. Novel rifapentine-based regimens and treatment support based on behavioural science...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-09-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/9/e057717.full |
| _version_ | 1828412161886519296 |
|---|---|
| author | Marc Lipman Ibrahim Abubakar Chris Griffiths 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 Charlotte Layton |
| author_facet | Marc Lipman Ibrahim Abubakar Chris Griffiths 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 Charlotte Layton |
| author_sort | Marc Lipman |
| collection | DOAJ |
| description | Introduction The successful scale-up of a latent tuberculosis (TB) infection testing and treatment programme is essential to achieve TB elimination. However, poor adherence compromises its therapeutic effectiveness. Novel rifapentine-based regimens and treatment support based on behavioural science theory may improve treatment adherence and completion.Methods and analysis A pragmatic multicentre, open-label, randomised controlled trial assessing the effect of novel short-course rifapentine-based regimens for TB prevention and additional theory-based treatment support on treatment adherence against standard-of-care. Participants aged between 16 and 65 who are eligible to start TB preventive therapy will be recruited in England. 920 participants will be randomised to one of six arms with allocation ratio of 5:5:6:6:6:6: daily isoniazid +rifampicin for 3 months (3HR), routine treatment support (control); 3HR, additional treatment support; weekly isoniazid +rifapentine for 3 months (3HP), routine treatment support; weekly 3HP, additional treatment support ; daily isoniazid +rifapentine for 1 month (1HP), routine treatment support; daily 1HP, additional treatment support. Additional treatment support comprises reminders using an electronic pillbox, a short animation, and leaflets based on the perceptions and practicalities approach. The primary outcome is adequate treatment adherence, defined as taking ≥90% of allocated doses within the pre-specified treatment period, measured by electronic pillboxes. Secondary outcomes include safety and TB incidence within 12 months. We will conduct process evaluation of the trial interventions and assess intervention acceptability and fidelity and mechanisms for effect and estimate the cost-effectiveness of novel regimens. The protocol was developed with patient and public involvement, which will continue throughout the trial.Ethics and dissemination Ethics approval has been obtained from The National Health Service Health Research Authority (20/LO/1097). All participants will be required to provide written informed consent. We will share the results in peer-reviewed journals.Trial registration number EudraCT 2020-004444-29. |
| first_indexed | 2024-12-10T12:44:07Z |
| format | Article |
| id | doaj.art-233c0dfe71dc4d8d869745da45323a8c |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-12-10T12:44:07Z |
| publishDate | 2022-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-233c0dfe71dc4d8d869745da45323a8c2022-12-22T01:48:26ZengBMJ Publishing GroupBMJ Open2044-60552022-09-0112910.1136/bmjopen-2021-057717Evaluating the effect of short-course rifapentine-based regimens with or without enhanced behaviour-targeted treatment support on adherence and completion of treatment for latent tuberculosis infection among adults in the UK (RID-TB: Treat): protocol for an open-label, multicentre, randomised controlled trialMarc Lipman0Ibrahim Abubakar1Chris Griffiths2Robert Horne3Alex Ghanouni4Heinke Kunst5Mike Mandelbaum6Molebogeng X Rangaka7Karen Sanders8Peter J White9Angela Crook10Dominik Zenner11Trinh Duong12Vanessa Hack13Julian Surey14Yohhei Hamada15Henry Bern16Joanna Calvert17Marie Francis18Amy Louise Clarke19Ellen Owen-Powell20Helen L Booth21Charlotte Layton22UCL Respiratory, Division of Medicine, University College London, London, UK1 Institute for Global Health, University College London, London, UKBlizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UKCentre for Behavioural Medicine, UCL School of Pharmacy, 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, UKMRC Centre for Global Infectious Disease Analysis, Imperial College London, London, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UKInstitute for Global Health, University College 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, UKUniversity College London Hospitals NHS Foundation Trust, London, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UKIntroduction The successful scale-up of a latent tuberculosis (TB) infection testing and treatment programme is essential to achieve TB elimination. However, poor adherence compromises its therapeutic effectiveness. Novel rifapentine-based regimens and treatment support based on behavioural science theory may improve treatment adherence and completion.Methods and analysis A pragmatic multicentre, open-label, randomised controlled trial assessing the effect of novel short-course rifapentine-based regimens for TB prevention and additional theory-based treatment support on treatment adherence against standard-of-care. Participants aged between 16 and 65 who are eligible to start TB preventive therapy will be recruited in England. 920 participants will be randomised to one of six arms with allocation ratio of 5:5:6:6:6:6: daily isoniazid +rifampicin for 3 months (3HR), routine treatment support (control); 3HR, additional treatment support; weekly isoniazid +rifapentine for 3 months (3HP), routine treatment support; weekly 3HP, additional treatment support ; daily isoniazid +rifapentine for 1 month (1HP), routine treatment support; daily 1HP, additional treatment support. Additional treatment support comprises reminders using an electronic pillbox, a short animation, and leaflets based on the perceptions and practicalities approach. The primary outcome is adequate treatment adherence, defined as taking ≥90% of allocated doses within the pre-specified treatment period, measured by electronic pillboxes. Secondary outcomes include safety and TB incidence within 12 months. We will conduct process evaluation of the trial interventions and assess intervention acceptability and fidelity and mechanisms for effect and estimate the cost-effectiveness of novel regimens. The protocol was developed with patient and public involvement, which will continue throughout the trial.Ethics and dissemination Ethics approval has been obtained from The National Health Service Health Research Authority (20/LO/1097). All participants will be required to provide written informed consent. We will share the results in peer-reviewed journals.Trial registration number EudraCT 2020-004444-29.https://bmjopen.bmj.com/content/12/9/e057717.full |
| spellingShingle | Marc Lipman Ibrahim Abubakar Chris Griffiths 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 Charlotte Layton Evaluating the effect of short-course rifapentine-based regimens with or without enhanced behaviour-targeted treatment support on adherence and completion of treatment for latent tuberculosis infection among adults in the UK (RID-TB: Treat): protocol for an open-label, multicentre, randomised controlled trial BMJ Open |
| title | Evaluating the effect of short-course rifapentine-based regimens with or without enhanced behaviour-targeted treatment support on adherence and completion of treatment for latent tuberculosis infection among adults in the UK (RID-TB: Treat): protocol for an open-label, multicentre, randomised controlled trial |
| title_full | Evaluating the effect of short-course rifapentine-based regimens with or without enhanced behaviour-targeted treatment support on adherence and completion of treatment for latent tuberculosis infection among adults in the UK (RID-TB: Treat): protocol for an open-label, multicentre, randomised controlled trial |
| title_fullStr | Evaluating the effect of short-course rifapentine-based regimens with or without enhanced behaviour-targeted treatment support on adherence and completion of treatment for latent tuberculosis infection among adults in the UK (RID-TB: Treat): protocol for an open-label, multicentre, randomised controlled trial |
| title_full_unstemmed | Evaluating the effect of short-course rifapentine-based regimens with or without enhanced behaviour-targeted treatment support on adherence and completion of treatment for latent tuberculosis infection among adults in the UK (RID-TB: Treat): protocol for an open-label, multicentre, randomised controlled trial |
| title_short | Evaluating the effect of short-course rifapentine-based regimens with or without enhanced behaviour-targeted treatment support on adherence and completion of treatment for latent tuberculosis infection among adults in the UK (RID-TB: Treat): protocol for an open-label, multicentre, randomised controlled trial |
| title_sort | evaluating the effect of short course rifapentine based regimens with or without enhanced behaviour targeted treatment support on adherence and completion of treatment for latent tuberculosis infection among adults in the uk rid tb treat protocol for an open label multicentre randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/9/e057717.full |
| work_keys_str_mv | AT marclipman evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT ibrahimabubakar evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT chrisgriffiths evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT roberthorne evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT alexghanouni evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT heinkekunst evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT mikemandelbaum evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT molebogengxrangaka evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT karensanders evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT peterjwhite evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT angelacrook evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT dominikzenner evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT trinhduong evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT vanessahack evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT juliansurey evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT yohheihamada evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT henrybern evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT joannacalvert evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT mariefrancis evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT amylouiseclarke evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT ellenowenpowell evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT helenlbooth evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle AT charlottelayton evaluatingtheeffectofshortcourserifapentinebasedregimenswithorwithoutenhancedbehaviourtargetedtreatmentsupportonadherenceandcompletionoftreatmentforlatenttuberculosisinfectionamongadultsintheukridtbtreatprotocolforanopenlabelmulticentrerandomisedcontrolle |