TY - JOUR
T1 - 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
T2 - A multicentre, randomised controlled trial of the ProLife programme in South Africa
AU - Louwagie, Goedele
AU - Kanaan, Mona
AU - Morojele, Neo Keitumetse
AU - Van Zyl, Andre
AU - Moriarty, Andrew Stephen
AU - Li, Jinshuo
AU - Siddiqi, Kamran
AU - Turner, Astrid
AU - Mdege, Noreen Dadirai
AU - Omole, Olufemi Babatunde
AU - Tumbo, John
AU - Bachmann, Max
AU - Parrott, Steve
AU - Ayo-Yusuf, Olalekan A.
N1 - Funding Information:
Contributors GL led the study design and manuscript preparation and contributed to the monitoring of the study implementation. MK contributed to the study design and the manuscript, led the sample size determination and did the statistical analysis. NKM contributed to study design, particularly with respect to development of the motivational interviewing (MI) intervention, did the analysis of the MI data and contributed to the manuscript writing. AVZ led the data management and short message service system, monitored data quality and contributed to data analysis and manuscript writing. ASM contributed to study design and led on the preparation of the manuscript. NDM contributed to the study design, intervention development and manuscript preparation. JL and SP led the economic evaluation. AT contributed to the economic evaluation. JT was site lead for the Bojanala subdistrict. OBO was site lead for the Sedibeng subdistrict. MB contributed to the study design, data interpretation and the manuscript. KS and OAA-Y are coprincipal investigators. Both contributed to study design, data interpretation and manuscript writing. All authors read and approved the final draft of the manuscript. OAA-Y is the guarantor. Funding This project was funded by the SA-Medical Research/Newton Foundation Grant on TB control implementation science (UK/South Africa Newton Fund RFA: TB control implementation science (MRC-RFA-02: TB -05-2015)). This UK funded award is part of the EDCTP2 programme supported by the European Union. 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.
Publisher Copyright:
©
PY - 2022/2/14
Y1 - 2022/2/14
N2 - 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.
AB - 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.
KW - HIV & AIDS
KW - health economics
KW - organisation of health services
KW - public health
KW - substance misuse
KW - tuberculosis
UR - http://www.scopus.com/inward/record.url?scp=85124680446&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-056496
DO - 10.1136/bmjopen-2021-056496
M3 - Article
C2 - 35165113
AN - SCOPUS:85124680446
SN - 2044-6055
VL - 12
JO - BMJ Open
JF - BMJ Open
IS - 2
M1 - e056496
ER -