A brief motivational intervention targeting tobacco smoking, alcohol and medication adherence to improve TB treatment outcomes in adult TB patients: A multi-center, randomised controlled trial of the ProLife programme in South Africa

<b>Project Summary</b> This was a prospective, multi-centre, two-arm individual randomised controlled trial looking at the effectiveness and costeffectiveness of a complex behavioural intervention (the ProLife programme) on improving TB and lifestyle-related outcomes in three provinces of South Africa. The ProLife programme consisted of an MI counselling strategy, delivered by lay health workers, augmented with subsequent SMS. We aimed to recruit 696 adult participants (aged 18 years and over) with drug-sensitive pulmonary TB who were current smokers and/or report harmful or hazardous alcohol use. Patients were consecutively enrolled at 27 clinics in three different health districts in South Africa. Participants randomised individually to the intervention arm received three MI counselling sessions one month apart. Each MI session was followed by twice-weekly SMS messages targeting treatment adherence, alcohol use and tobacco smoking, as appropriate. <b>Data Management </b> Data were collected at baseline, 3 and 6-months and recorded by fieldworkers equipped with mobile phones with the ProLife mobile data collection application installed. The application was built on CommCare HQ (https://www.dimagi.com/commcare/). CommCare HQ was also configured to schedule SMS delivery. The SMS gateway, Telerivet (https://telerivet.com/), was used to send the SMS messages via the participants’ mobile network operators (MNOs). (https://guide.telerivet.com/hc/en-us/articles/360038959611Message-Statuses) data was analyzed to assess SMS fidelity with a primary focus on messages that were delivered. The data was downloaded and prepared in R for analysis in Stata and SPSS. <b>Codebook </b> The codebook is imbedded in the Stata (.dta) file. An excel version of the codebook can be found in ProLife Codebook_2020-06-21.xlsx. <b>Statistical Analysis Plan </b> The statistical analysis plan could be found in SAP_PROLIFE_2020_05_29_MK_toShare_09_07u14_GL2.docx <br>