Effect of a brief motivational interview and text message intervention targeting tobacco smoking, alcohol use and medication adherence to improve tuberculosis treatment outcomes in adult patients with tuberculosis: a multicentre, randomised controlled trial of the ProLife programme in South Africa.

Objective: To investigate the effectiveness of a complex behavioural intervention, ProLife, on tuberculosis (TB) treatment success, medication adherence, alcohol use and tobacco smoking.
Design: Multicentre, individual, randomised controlled trial where participants were assigned (1:1) to the ProLife intervention or usual care.
Setting: 27 primary care clinics in South Africa.
Participants: 574 adults starting treatment for drug-sensitive pulmonary TB who smoked tobacco or reported harmful/hazardous alcohol use.
Interventions: The intervention, delivered by lay health workers (LHWs), consisted of three brief motivational interviewing (MI) sessions, augmented with short message service (SMS) messages, targeting medication adherence, alcohol use and tobacco smoking.
Outcome Measures: The primary outcome was successful versus unsuccessful TB treatment at 6-9 months, from TB records. Secondary outcomes were biochemically confirmed sustained smoking cessation, reduction in the Alcohol Use Disorder Identification Test (AUDIT) score, improved TB and antiretroviral therapy (ART) adherence and ART initiation, each measured at 3 and 6 months by questionnaires; and cure rates in patients who had bacteriology-confirmed TB at baseline, from TB records.
Results: Between 15 November 2018 and 31 August 2019, 574 participants were randomised to receive either the intervention (n=283) or usual care (n=291). TB treatment success rates did not differ significantly between intervention (67.8%) and control (70.1%; OR 0.9, 95% CI 0.64% to 1.27%). There was no evidence of an effect at 3 and 6 months, respectively, on continuous smoking abstinence (OR 0.65, 95% CI 0.37 to 1.14; OR 0.76, 95% CI 0.35 to 1.63), TB medication adherence (OR 1.22, 95% CI 0.52 to 2.87; OR 0.89, 95% CI 0.26 to 3.07), taking ART (OR 0.79, 95% CI 0.38 to 1.65; OR 2.05, 95% CI 0.80 to 5.27) or AUDIT scores (mean score difference 0.55, 95% CI -1.01 to 2.11; -0.04, 95% CI -2.0 to 1.91) and adjusting for baseline values. Cure rates were not significantly higher (OR 1.16, 95% CI 0.83 to 1.63).
Conclusions: Simultaneous targeting of multiple health risk behaviours with MI and SMS using LHWs may not be an effective approach to improve TB outcomes.
Trial Registration Number: ISRCTN62728852.
Competing Interests: Competing interests: OAA-Y, the principal investigator, received a research grant (MRC-RFA-02: TB -05-2015) which was allocated to Sefako Makgatho Health Sciences University to pay for the expenses related to the research project, and received support for attending meetings and for travel by Tax Justice Network Africa. He is the vice chair of the Standing Committee on Health, Academy of Science, SA (not remunerated). As coprincipal investigator, KS received part of the MRC-Newton research grant (MRC-RFA-02: TB -05-2015), which was allocated to the University of York to support the research by the authors affiliated to the University of York (KS, NDM, MK, SP and JL). GL received a small monthly remuneration per month from 1 October 2018 to 30 June 2020 as academic research coordinator. AVZ was employed as a research data manager on a part-time basis from 1 September 2017 to 30 June 2020.
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