Evidence map›Paper›PMID 31349850›Full record

ArticleTrials2019

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.

Andrew Stephen Moriarty, Goedele Maria Louwagie, Noreen Dadirai Mdege, Neo Morojele, John Tumbo, Olufemi Babatunde Omole, Max Oscar Bachmann, Mona Kanaan, Astrid Turner, Steve Parrott and 2 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Andrew Stephen MoriartyDepartment of Health Sciences and the Hull York Medical School, University of York, York, UK. andrewmoriarty1@doctors.org.uk.ORCID http://orcid.org/0000-0003-0770-3262
Goedele Maria LouwagieSchool of Health Systems and Public Health, University of Pretoria and Sefako Makgatho Health Sciences University, Ga-Rankuwa, South Africa.
Noreen Dadirai MdegeDepartment of Health Sciences, University of York, York, UK.
Neo MorojeleAlcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Cape Town, South Africa.
John TumboDepartment of Family Medicine, Sefako Makgatho Health Sciences University, Ga-Rankuwa, South Africa.
Olufemi Babatunde OmoleDepartment of Family Medicine, University of Witwatersrand, Johannesburg, South Africa.
Max Oscar BachmannNorwich Medical School, University of East Anglia, Norwich, UK.
Mona KanaanDepartment of Health Sciences, University of York, York, UK.
Astrid TurnerSchool of Health Systems and Public Health, University of Pretoria, Pretoria, South Africa.
Steve ParrottDepartment of Health Sciences, University of York, York, UK.
Kamran SiddiqiDepartment of Health Sciences and the Hull York Medical School, University of York, York, UK.
Olalekan Abdulwahab Ayo-YusufAfrica Centre for Tobacco Industry Monitoring and Policy Research, Sefako Makgatho Health Sciences University, Ga-Rankuwa, South Africa.

Funding

Medical Research Council MC_PC_16024South African Medical Research Council MRC-RFA-02: TB -05-2015
6 · The paper itself

Abstract

backgroundSouth 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.

methodsThis 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 registrationISRCTN Registry, ISRCTN62728852. Registered on 13 April 2018.

Indexed as

Health BehaviorMotivational InterviewingRisk Reduction BehaviorText MessagingAlcohol DrinkingAnti-HIV AgentsAntitubercular AgentsFemaleHealth Knowledge, Attitudes, PracticeHumansMaleMedication AdherenceMulticenter Studies as TopicPragmatic Clinical Trials as TopicProspective StudiesSmoking CessationAnti-HIV AgentsAntitubercular AgentsAdherenceAlcoholAnti-retroviral therapyMotivational interviewingSmokingTuberculosis

Identifiers

PMID31349850
PMCPMC6660690

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.