Methods: This is a prospective, multi-centre, two-arm individual randomised controlled trial looking at the effectiveness and cost-effectiveness of a complex behavioural intervention (the ProLife programme) on improving TB and lifestyle-related outcomes in 3 provinces of South Africa. The ProLife programme consists of an MI counselling strategy, delivered by lay health workers, augmented with subsequent SMS. We aim to recruit 696 adult participants (aged 18 years and over) with drug-sensitive pulmonary TB who are current smokers and/or report harmful or hazardous alcohol use. Patients will be consecutively enrolled at 27 clinics in 3 different health districts in South Africa. Participants randomised individually to the intervention arm 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, as appropriate. We will assess the effect on TB treatment success, using standard World Health Organization (WHO) treatment outcome definitions (primary outcome), as well as on a range of secondary outcomes including smoking cessation, reduction in alcohol use and TB medication and anti-retroviral therapy adherence. Secondary outcomes will be measured at 3 and 6 months follow-up.
Discussion: This trial aligns with the WHO agenda of integrating TB care with the care for chronic diseases of life-style, such as provision of smoking cessation treatments, and with the use of digital technologies. If the ProLife programme is found to be effective and cost- effective, the programme could have significant implications for TB treatment globally and could be successfully implemented in a wide range of TB treatment settings.