Evidence map›Paper›PMID 34972128›Full record

ArticlePloS one2021

Protocol of a parallel group Randomized Control Trial (RCT) for Mobile-assisted Medication Adherence Support (Ma-MAS) intervention among Tuberculosis patients.

Zekariyas Sahile, Lua Perimal-Lewis, Paul Arbon, Anthony John Maeder

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 30% of its field
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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
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

4 authors at 1 institution in 2 countries.

Zekariyas SahileDepartment of Public Health, Ambo University, Ambo, Ethiopia.ORCID 0000-0002-7215-9489
Lua Perimal-LewisCollege of Science & Engineering, Flinders Digital Health Research Centre, Flinders University, Adelaide, SA, Australia.
Paul ArbonCollege of Nursing & Health Sciences, Flinders University, Adelaide SA, Australia.
Anthony John MaederFlinders Digital Health Research Centre College of Nursing & Health Sciences, Flinders University, Adelaide, SA, Australia.
Flinders University · AU

Funding

Ethiopia-Emory TB Research Training ProgramD43TW009127 · FIC · EMORY UNIVERSITY · PI HENRY M BLUMBERG, Kidist Bobosha · 2013 to 2026
$3.4M
FIC NIH HHS D43 TW009127
6 · The paper itself

Abstract

backgroundNon-adherence to Tuberculosis (TB) medication is a serious threat to TB prevention and control programs, especially in resource-limited settings. The growth of the popularity of mobile phones provides opportunities to address non-adherence, by facilitating direct communication more frequently between healthcare providers and patients through SMS texts and voice phone calls. However, the existing evidence is inconsistent about the effect of SMS interventions on TB treatment adherence. Such interventions are also seldom developed based on appropriate theoretical foundations. Therefore, there is a reason to approach this problem more rigorously, by developing the intervention systematically with evidence-based theory and conducting the trial with strong measurement methods.

methodsThis study is a single-blind parallel-group design individual randomized control trial. A total of 186 participants (93 per group) will be individually randomized into one of the two groups with a 1:1 allocation ratio by a computer-generated algorithm. Group one (intervention) participants will receive daily SMS texts and weekly phone calls concerning their daily medication intake and medication refill clinic visit reminder and group two (control) participants will receive the same routine standard treatment care as the intervention group, but no SMS text and phone calls. All participants will be followed for two months of home-based self-administered medication during the continuation phases of the standard treatment period. Urine test for the presence of isoniazid (INH) drug metabolites in urine will be undertaken at the random point at the fourth and eighth weeks of intervention to measure medication adherence. Medication adherence will also be assessed by self-report measurements using the AIDS Clinical Trial Group adherence (ACTG) and Visual Analogue Scales (VAS) questionnaires, and clinic appointment attendance registration. Multivariable regression model analysis will be employed to assess the effect of the Ma-MAS intervention at a significance level of P-value < 0.05 with a 95% confidence interval. DISCUSSION: For this trial, a mobile-assisted medication adherence intervention will first be developed systematically based on the Medical Research Council framework using appropriate behavioural theory and evidence. The trial will then evaluate the effect of SMS texts and phone calls on TB medication adherence. Evidence generated from this trial will be highly valuable for policymakers, program managers, and healthcare providers working in Ethiopia and beyond.

trial registrationThe trial is registered in the Pan-Africa Clinical Trials Registry with trial number PACTR202002831201865.

Indexed as

Antitubercular AgentsCell PhoneMedication AdherenceText MessagingTuberculosisAdolescentAdultFemaleHumansIsoniazidMaleMiddle AgedRandomized Controlled Trials as TopicReminder SystemsSingle-Blind MethodYoung AdultAntitubercular AgentsIsoniazid

Identifiers

PMID34972128
PMCPMC8719740
OpenAlexW4205827768

What OpenQuestion holds

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LicenceCC BY
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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.