ImPROving TB outcomes by modifying LIFE-style behaviours through a brief motivational intervention followed by short text messages (ProLife): study protocol for a randomised controlled trial
Autor: | Olufemi B. Omole, Mona Kanaan, Kamran Siddiqi, John Tumbo, Andrew S Moriarty, Noreen Dadirai Mdege, Olalekan A. Ayo-Yusuf, Astrid Turner, Goedele M. C. Louwagie, Max O Bachmann, Steve Parrott, Neo K. Morojele |
---|---|
Rok vydání: | 2019 |
Předmět: |
Male
Health Knowledge Attitudes Practice Time Factors medicine.medical_treatment Health Behavior Antitubercular Agents Psychological intervention Motivational interviewing Medicine (miscellaneous) law.invention South Africa Study Protocol 0302 clinical medicine Randomized controlled trial law Multicenter Studies as Topic Pharmacology (medical) Prospective Studies 030212 general & internal medicine lcsh:R5-920 Smoking Treatment Outcome Female lcsh:Medicine (General) Alcohol Anti-retroviral therapy medicine.medical_specialty Short Message Service Tuberculosis Alcohol Drinking Anti-HIV Agents Motivational Interviewing Affect (psychology) Medication Adherence 03 medical and health sciences Intervention (counseling) Pragmatic Clinical Trials as Topic medicine Humans Text Messaging business.industry medicine.disease Adherence Family medicine Smoking cessation Smoking Cessation business Risk Reduction Behavior 030217 neurology & neurosurgery |
Zdroj: | Trials Trials, Vol 20, Iss 1, Pp 1-12 (2019) |
ISSN: | 1745-6215 |
Popis: | Background South Africa is among the seven highest tuberculosis (TB) burden countries. Harmful lifestyle behaviours, such as smoking and alcohol, and poor adherence to medication can affect clinical outcomes. Modification of these behaviours is likely to improve TB treatment outcomes and has proven possible using motivational interviewing (MI) techniques or use of short message service (SMS) text messaging. There have been no studies assessing the effect of combined MI and SMS interventions on multiple lifestyle factors and TB treatment outcomes. Methods This is a prospective, multicentre, 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 three 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 three different health districts in South Africa. Participants randomised individually to the intervention arm will receive three MI counselling sessions one 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 the three-month and six-month follow-ups. Discussion This trial aligns with the WHO agenda of integrating TB care with the care for chronic diseases of lifestyle, 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. Trial registration ISRCTN Registry, ISRCTN62728852. Registered on 13 April 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3551-9) contains supplementary material, which is available to authorized users. |
Databáze: | OpenAIRE |
Externí odkaz: |