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: