Effectiveness and cost-effectiveness of an mHealth intervention (mTB-Tobacco) for smoking cessation in people with tuberculosis
| ISRCTN | ISRCTN86971818 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86971818 |
| Secondary identifying numbers | AC22139 |
- Submission date
- 29/08/2023
- Registration date
- 11/09/2023
- Last edited
- 19/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English Summary
Background and study aims
Quit 4 TB Trial is a research study on tobacco smoking among tuberculosis (TB) patients. TB is an infectious disease caused by bacteria that usually attacks the lungs but can also affect any part of the body, including bone, brain and nervous system. It is spread when a person inhales tiny droplets from the coughs or sneezes of an infected person. Tobacco smoking is bad for health, particularly for those with TB. If TB patients continue to smoke during their treatment they may not recover from it. Quit 4 TB trial is aimed to test how best to get TB patients to stop smoking and to successfully complete TB treatment. However, tobacco smoking is highly addictive and smokers find it difficult to give up. Researchers have designed a mTB-Tobacco programme in which we will send motivational and informative short message service (SMS) messages throughout a patient's TB treatment.
Who can participate?
Patients aged at least 15 years with drug-sensitive pulmonary TB in the last 4 weeks who currently smoke tobacco on a daily basis or have only stopped or reduced smoking (less than daily) since being diagnosed with TB
What does the study involve?
Each participating clinic will be randomly allocated into a group by chance. Patients who attend the health centre that is allocated to the mTB-Tobacco group will be given access to the mHealth smoking cessation package. mHealth is a general term for the use of mobile devices (e.g. mobile phones and other wireless technology) in medical care and public health services. mTB-Tobacco programme delivers SMS messages via mobile phones to TB patients. Participants in this group must have access to a personal mobile phone to receive SMS content. The researchers will send a total of 134 SMS messages over a period of 6 months to help them quit smoking and complete their TB treatment effectively. In the first 2 months, the frequency of messages would be 4 to 5 messages per day, in the next two months the frequency would reduce to 1 or 2 messages per day and in the last 2 months there would be 1 message sent per week. Patients who attend the health centre that is allocated to standard usual care will receive education leaflets from TB health professionals.
What are the possible benefits and risks of participating?
Participants will be provided with some advice on how to quit smoking and successfully complete TB treatment. There are no potential risks/harms associated with taking part in this study.
Where is the study run from?
1. ARK Foundation (Bangladesh)
2. The Initiative (Pakistan)
3. University of Edinburgh (UK)
When is the study starting and how long is it expected to run for?
June 2022 to March 2026
Who is funding the study?
The NIHR Global Health Research Unit on Respiratory Health (RESPIRE) (UK)
Who is the main contact?
1. Dr Amina Khan, aminakhan67@gmail.com
2. Prof. Rumana Huque, rumanah14@yahoo.com
Contact information
Principal Investigator
The Hull York Medical School
University of York
York
YO10 5DD
United Kingdom
 ORCID ID |
0000-0003-1529-7778 |
|---|---|
| Phone | +44 (0)1904 321335 |
| kamran.siddiqi@york.ac.uk |
Principal Investigator
AKR Foundation
Suite C-3 & C-4
House #06
Road # 109
Gulshan-2, Dhaka-1212
Dhaka
1212
Bangladesh
| Phone | +88 (0)2 55069866 |
|---|---|
| Rumana@arkfoundationbd.org |
Principal Investigator
The Initiative
Main Office
Orange Grove Farm, Main Korung Rd
Banigala
Islamabad
44000
Pakistan
| Phone | +92 (0)51 8732651 |
|---|---|
| amina.khan@theinitiative.org.pk |
Scientific
The Initiative
103 Iqbal Heights
Korang Road
Bani Gala
Islamabad
-
Pakistan
| ORCID ID |
0000-0003-2878-0435 |
|---|---|
| Phone | +923425091321 |
| zahidmaham487@gmail.com |
Scientific
Usher Institute
The University of Edinburgh
Room 216B
Doorway 3, Teviot Place
Edinburgh
EH8 9AG
United Kingdom
| ORCID ID |
0000-0002-3189-0558 |
|---|---|
| Phone | +44 (0)131 6509452 |
| ak.lim@ed.ac.uk |
Study information
| Study design | Two-stage adaptive design multi-country randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Prevention, Quality of life, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A mHealth intervention (mTB-Tobacco) for smoking cessation in people with tuberculosis: a two-stage adaptive design, multi-country randomised controlled trial |
| Study acronym | Quit 4 TB Trial |
| Study hypothesis | mTB Tobacco is more effective and cost effective than usual care. mTB Tobacco is as effective and cost effective as face-to-face behavioural support. |
| Ethics approval(s) |
Approved 26/04/2023, Edinburgh Medical School Research Ethics Committee (EMREC) (University of Edinburgh, Edinburgh, EH16 4TJ, United Kingdom; +44 (0)131 242 7441; emrec@ed.ac.uk), ref: EMREC-RESPIRE-23-01 |
| Condition | Smoking cessation in people with tuberculosis |
| Intervention | Current interventions as of 19/03/2025: This trial is a clustered RCT where health facilities will be randomly allocated to the different trial arms. The health facilities (clusters) would be randomised 2:2:1 to mTB-Tobacco (intervention A), face-to-face (intervention B), or standard care (Control). An independent statistician who will be blinded to centres, will identify and use computer-generated random-number lists to generate the allocation sequence. The allocation will be based on using minimisation to ensure balance across the groups on the average number of TB patients seen per month and geographical location (Bangladesh and Pakistan). Using an adaptive design, the researchers will conduct a multi-centre, cluster randomized, controlled trial consisting of four phases. Phase 1 involves consultation with Patients and Public Involvement (PPI) group about the study processes. PPI members will also review and provide feedback on the participant facing materials. Phase 2 is the pilot study. In Phase 3 (superiority trial), which will last for 12 months (6 months recruitments and 6 months follow-ups), the researchers will compare mTB-Tobacco (intervention A) with usual care (control). In Phase 4 (non-inferiority trial), which will last for another 12 months (6 months recruitment and 6 months follow-ups), the researchers will compare mTB-Tobacco (intervention A) with face-to-face behavioural support (intervention B). mTB-TOBACCO (INTERVENTION A) The mTB-Tobacco programme (intervention A) is designed to send short message service (SMS) content with two distinct areas of intervention. The first tries to instil behaviour change in patients to quit the habit of tobacco use and the second includes a combination of supportive motivational and informative messages through the period of TB treatment. The overall outcome is that a person is able to both successfully quit tobacco consumption and complete TB treatment. FACE-2-FACE BEHAVIOURAL SUPPORT (INTERVENTION B) This consists of an adapted version of a pre-developed and proven effective intervention to help people to quit smoking and smokeless tobacco use.10 This consists of two face-to-face sessions delivered at day 0 and day 5 (+2) and which last 10 and 5 minutes respectively. The sessions will be structured using an educational flipbook; the session on day 0 will be aimed at encouraging tobacco users to see themselves as non-users and set a plan for a quit date five days later; with a session on the quit date (day 5) to review progress. Further encouragement and support (if needed) will be offered at a subsequent visit at week 5. STANDARDISED USUAL CARE The TB health professionals will be provided with patient education leaflets to be given out to all patients allocated to the respective trial arm. Leaflets for patients and others in the house contain information on the harmful effects of tobacco and advice on stopping its use. _____ Previous interventions: This trial is a clustered RCT where health facilities will be randomly allocated to the different trial arms. The health facilities (clusters) would be randomised 2:2:1 to mTB-Tobacco (intervention A), face-to-face (intervention B), or standard care (Control). An independent statistician who will be blinded to centres, will identify and use computer-generated random-number lists to generate the allocation sequence. The allocation will be based on using minimisation to ensure balance across the groups on the average number of TB patients seen per month and geographical location (Bangladesh and Pakistan). Using an adaptive design, the researchers will conduct a multi-centre, cluster randomized, controlled trial consisting of two phases. In Phase 1 (superiority trial), which will last for 12 months (6 months recruitments and 6 months follow-ups), the researchers will compare mTB-Tobacco (intervention A) with usual care (control). In Phase 2 (non-inferiority trial), which will last for another 12 months (6 months recruitment and 6 months follow-ups), the researchers will compare mTB-Tobacco (intervention A) with face-to-face behavioural support (intervention B). mTB-TOBACCO (INTERVENTION A) The mTB-Tobacco programme (intervention A) is designed to send short message service (SMS) content with two distinct areas of intervention. The first tries to instil behaviour change in patients to quit the habit of tobacco use and the second includes a combination of supportive motivational and informative messages through the period of TB treatment. The overall outcome is that a person is able to both successfully quit tobacco consumption and complete TB treatment. FACE-2-FACE BEHAVIOURAL SUPPORT (INTERVENTION B) This consists of an adapted version of a pre-developed and proven effective intervention to help people to quit smoking and smokeless tobacco use.10 This consists of two face-to-face sessions delivered at day 0 and day 5 (+2) and which last 10 and 5 minutes respectively. The sessions will be structured using an educational flipbook; the session on day 0 will be aimed at encouraging tobacco users to see themselves as non-users and set a plan for a quit date five days later; with a session on the quit date (day 5) to review progress. Further encouragement and support (if needed) will be offered at a subsequent visit at week 5. STANDARDISED USUAL CARE The TB health professionals will be provided with patient education leaflets to be given out to all patients allocated to the respective trial arm. Leaflets for patients and others in the house contain information on the harmful effects of tobacco and advice on stopping its use. |
| Intervention type | Mixed |
| Primary outcome measure | Biochemically verified continuous abstinence at 6 months post-randomisation. Abstinence is defined as self-report of not having used more than 5 cigarettes, bidis, or water pipe sessions since the quit date, verified biochemically by a breath carbon monoxide (CO) reading of less than 10 ppm at month 6. |
| Secondary outcome measures | 1. Point abstinence, defined as a self-report of not using tobacco in the previous 7 days, assessed at week 9 and month 6 2. 2. Adherence to TB treatment: all registered TB patients’ medication logs (for anti-TB medication) are recorded on the ‘Treatment Support Card’; a copy of this card would be requested from the TB paramedic by the RA at Week 9 and Month 6 and attached with the patient case report form 3. TB Programme outcomes: the proportion of treatment success (including cured and completed treatment), treatment failure, defaulted and died will be recorded from the TB register (TB03) at month 6. The definitions of these outcomes are as follows: 3.1. Cured: A patient who was initially smear-positive and who was smear-negative in the last month of treatment (at month 6) and on at least one previous occasion 3.2. Completed treatment: A patient who completed treatment (at month 6) but did not meet the criteria for cure or failure 3.3.. Treatment failure: A patient who was initially smear-positive and who remained smear-positive at month 6 or later during treatment 3.4.. Defaulted: A patient whose treatment was interrupted for 2 consecutive months or more 3.5. Died: A patient who died from any cause during treatment 3.6.. Relapse: A patient who was previously treated for TB, was declared cured or treatment completed at the end of his most recent course of treatment, and is now diagnosed with a recurrent episode of TB (either a true relapse or a new episode of TB caused by reinfection) |
| Overall study start date | 01/06/2022 |
| Overall study end date | 31/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 15 Years |
| Sex | Both |
| Target number of participants | Phase 3 (superiority trial): 1080 TB smoker patients; Phase 4 (non-superiority trial): 1620 TB smoker patients |
| Participant inclusion criteria | 1. Age at least 15 years (counted as adult TB patients in Bangladesh and Pakistan) 2. Willing and able to provide written informed consent 3. Diagnosed with drug-sensitive pulmonary TB (smear positive or negative) in the last 4 weeks 4. Currently smokes tobacco on a daily basis or has only stopped or reduced smoking (less than daily) since being diagnosed with TB 5. Willing to quit tobacco use 6. Access to personal mobile phone |
| Participant exclusion criteria | 1. Less than 15 years of age 2. Retreatment TB, multidrug-resistant (MDR) TB, miliary or extrapulmonary TB 3. Currently using any pharmacotherapy for tobacco dependence 4. Unwilling or unable to provide written informed consent |
| Recruitment start date | 01/09/2023 |
| Recruitment end date | 30/09/2025 |
Locations
Countries of recruitment
- Bangladesh
- Pakistan
Study participating centres
Dhaka
1212
Bangladesh
Main Korung Road
Malpur
Bani Gala
Islamabad
44000
Pakistan
Sponsor information
University/education
Royal Infirmary of Edinburgh Site:
Research & Development Management Suite
The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)131 242 3330 |
|---|---|
| resgov@accord.scot | |
| Website | http://www.ed.ac.uk/home |
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | The results of the trial will be published in international journals and presented at national and international meetings in both TB care and Tobacco Control. A lay summary of results will be distributed to local TB care networks. |
| IPD sharing plan | De-identified datasets generated during and/or analysed during the current study will be stored in secure, password-protected DataVault / DataShare (to be decided at a later date) at the University of Edinburgh for a minimum of 10 years following the end of the study. DataShare is an open-access repository for anonymised data, which means that all non-identifiable data is freely available. DataVault is a secure repository for sensitive information which can only be accessed by approved researchers who have undergone a rigorous application and review process. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (preprint) | 10/12/2024 | 10/01/2025 | No | No | |
| Protocol article | 25/02/2025 | 26/02/2025 | Yes | No |
Editorial Notes
19/03/2025: The following changes were made to the trial record:
1. The interventions were changed.
2. The recruitment end date was changed from 28/03/2025 to 30/09/2025.
26/02/2025: Publication reference added.
10/01/2025: Publication reference added.
30/04/2024: The following changes were made:
1. The target number of participants was changed from "Pilot study (Bangladesh 8 participants (4 intervention); Pakistan:8 participants (4 intervention)); Total clusters in Superiority trial = 24 sites (Bangladesh 14 sites 526 patients; Pakistan: 10 sites 378 patients); Total clusters in Non-Inferiority trial = 40 sites (Bangladesh: 24 sites 888 patients; Pakistan: 16 sites 592 patients)" to "Pilot study (Bangladesh 8 participants (4 intervention); Pakistan: 8 participants (4 intervention)); Total clusters in Superiority trial = 27 sites (Bangladesh 15 sites 600 patients; Pakistan: 12 sites 480 patients); Total clusters in Non-Inferiority trial = 36 sites (Bangladesh: 22 sites 990 patients; Pakistan: 14 sites 630 patients)".
2. The target total enrolment was changed from 2384 to 2716.
03/10/2023: Contacts were added.
01/09/2023: Study's existence confirmed by the Edinburgh Medical School Research Ethics Committee (EMREC), Bangladesh Medical Research Council, Pakistan National Institute of Health National Bioethics Committee for Research and Pakistan Ministry of National Health Services Ethics Committee.
