Evidence map›Paper›PMID 39956136›Full record

ArticleTropical medicine & international health : TM & IH2025

An mHealth app technology to strengthen adverse event management of multi-drug-resistant tuberculosis in Vietnam: Protocol for a process evaluation of the V-SMART trial.

Binh Hoa Nguyen, Tho T H Dang, Duy Trinh Hoang, Thu Thuong Do, Luong Van Dinh, Viet Nhung Nguyen, Dinh Hoa Vu, Dorothy Drabarek, Tram N B Nguyen, Dang Vu and 6 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Tropical medicine & international health : TM & IH, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

16 authors.

Binh Hoa NguyenThe National Lung Hospital, Hanoi, Vietnam.
Tho T H DangWoolcock Institute of Medical Research, New South Wales, Australia.ORCID https://orcid.org/0000-0003-4046-9666
Duy Trinh HoangWoolcock Institute of Medical Research, New South Wales, Australia.
Thu Thuong DoThe National Lung Hospital, Hanoi, Vietnam.
Luong Van DinhThe National Lung Hospital, Hanoi, Vietnam.
Viet Nhung NguyenThe National Lung Hospital, Hanoi, Vietnam.
Dinh Hoa VuNational Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi, Vietnam.
Dorothy DrabarekFaculty of Medicine and Health, The University of Sydney, New South Wales, Australia.ORCID https://orcid.org/0000-0003-2893-5863
Tram N B NguyenWoolcock Institute of Medical Research, New South Wales, Australia.
Dang VuWoolcock Institute of Medical Research, New South Wales, Australia.
Thu Anh NguyenWoolcock Institute of Medical Research, New South Wales, Australia.ORCID https://orcid.org/0000-0002-2089-2902
Guy B MarksWoolcock Institute of Medical Research, New South Wales, Australia.
Joel NeginFaculty of Medicine and Health, The University of Sydney, New South Wales, Australia.
Greg J FoxWoolcock Institute of Medical Research, New South Wales, Australia.
Sarah BernaysFaculty of Medicine and Health, The University of Sydney, New South Wales, Australia.
H Manisha YapaFaculty of Medicine and Health, The University of Sydney, New South Wales, Australia.

Funding

National Foundation for Science and Technology Development NHMRC.108.02-2018.01National Health and Medical Research Council APP 1157643Woolcock Institute of Medical Research, Australia
6 · The paper itself

Abstract

backgroundDrug-related adverse events cause poorer treatment outcomes amongst people with multi-drug-resistant tuberculosis, exacerbating a major global public health problem. The Harnessing new mHealth technologies to Strengthen the Management of Multi-Drug-Resistant Tuberculosis in Vietnam (V-SMART) trial tests whether a mobile health (mHealth) application (app) can optimise management of drug-related adverse events, within routine health services in Vietnam. Implementation of digital health within routine services is complex and driven by behaviour change as well as a range of health system factors. Understanding implementation is key to informing the evidence base for digital health prior to scale up, despite its potential appeal.

methodsThrough a process evaluation of the V-SMART trial, we aim to (i) understand the multi-drug-resistant tuberculosis service delivery context and how trial procedures are implemented within services; (ii) describe 'dose' and 'reach' of the app; and (iii) understand health worker and patient perspectives of app implementation and identify areas for improvement. To achieve this, we will (i) conduct process maps (patient flow maps) to describe implementation of the mHealth intervention within routine multi-drug-resistant tuberculosis health services including adverse event management pathways at different levels of the health system; (ii) measure app usage by all participating health workers and people with multi-drug-resistant tuberculosis over time; and (iii) conduct a total of up to 45 semi-structured interviews in seven provinces, with people with multi-drug-resistant tuberculosis, health workers, and policymakers, to identify determinants of app uptake and suggestions for future person-centred app design. Interview topic guides are informed by the Theoretical Framework for Acceptability, Normalisation Process Theory, and the Tailored Implementation of Chronic Diseases framework respectively. DISCUSSION: The process evaluation will strongly complement the parent trial impact evaluation, and the economic evaluation. Moreover, it will inform future tailored approaches to scaling up digital health as part of broader health system strengthening initiatives.

Indexed as

Antitubercular AgentsMobile ApplicationsTelemedicineTuberculosis, Multidrug-ResistantHumansVietnamAntitubercular Agentsadverse event managementdigital healthmHealthmulti‐drug‐resistantMycobacterium tuberculosisprocess evaluationresource‐limitedtuberculosis

Identifiers

PMID39956136
PMCPMC11965015

What OpenQuestion holds

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Registered trials

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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.