ISRCTN62728852 2019.
| Study name | ImPROving TB outcomes by modifying LIFE‐style behaviours through a brief motivational intervention followed by short text messages |
| Methods | Prospective multi‐centre 2‐arm randomised controlled trial |
| Participants | Adult participants (aged ≥ 18 years) with drug‐sensitive pulmonary TB who are current smokers and/or report harmful or hazardous alcohol use, enrolled at 27 government TB clinics in 3 different health districts in South Africa Inclusion criteria 1. adult patients (aged ≥ 18 years) with drug‐sensitive (bacteriologically or clinically confirmed) PTB 2. Initiating TB treatment or on TB treatment for < 1 month (these include both ‘new’ and ‘retreatment’ patients) 3. Current smokers and/or hazardous/harmful drinkers who are not alcohol dependent (Alcohol Use Disorders Identification Test (AUDIT) score ≥ 8 for men or ≥ 7 for women but < 20) 4. Access to a functional mobile phone 5. Understands 1 of the 4 languages used for the trial (Sesotho, Setswana, Isizulu, or English) Exclusion criteria 1. Alcohol‐dependent participants (AUDIT score ≥ 20) 2. Extrapulmonary TB without PTB 3. Resistance to ≥ 1 TB drugs at baseline |
| Interventions |
Intervention Motivational interviewing counselling strategy delivered by lay health workers augmented with subsequent text messages (ProLife programme): participants will receive 3 MI counselling sessions 1 month apart. Each MI session will be followed by twice‐weekly SMS messages targeting treatment adherence, alcohol use, and tobacco smoking Control Usual TB treatment and support offered to TB patients |
| Outcomes |
Primary outcome TB treatment success Secondary outcomes 1. Sputum conversion 2. Smoking cessation (self‐report, exhaled CO) 3. Reduction in alcohol use (AUDIT) 4. TB medication and antiretroviral treatment adherence (assessed using the ACTG) 5. Proportion of HIV patients on ART 6. CES‐D 7. Economic evaluation |
| Starting date | 13 November 2018 |
| Contact information | Correspondence: andrewmoriarty1@doctors.org.uk, Andrew Stephen Moriarty, Department of Health Sciences and the Hull York Medical School, University of York, York, UK |
| Notes |