Evidence map›Paper›PMID 40790601›Full record

ArticleTrials2025

Community and Universal Testing for TB among close contacts of microbiologically confirmed pulmonary TB patients in two high TB burden countries: a protocol for a pragmatic cluster-randomised control trial.

Mgcini Moyo, Thobani Ntshiqa, Yohhei Hamada, Andrew Copas, Issa Sabi, Elias Nyanda Ntinginya, Julieth Lalashowi, Manthomeng Matete, Griffiths Kubeka, Lindiwe Tsope and 10 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. 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
–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

1 citing paper in PubMed.

  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

20 authors.

Mgcini MoyoThe Aurum Institute, Johannesburg, South Africa. MMoyo@auruminstitute.org.ORCID http://orcid.org/0009-0003-1090-0918
Thobani NtshiqaThe Aurum Institute, Johannesburg, South Africa.
Yohhei HamadaInstitute for Global Health, University College London, London, UK.
Andrew CopasInstitute for Global Health, University College London, London, UK.
Issa SabiMbeya Medical Research Centre, National Institute for Medical Research, Dar Es Salaam, Tanzania.
Elias Nyanda NtinginyaMbeya Medical Research Centre, National Institute for Medical Research, Dar Es Salaam, Tanzania.
Julieth LalashowiMbeya Medical Research Centre, National Institute for Medical Research, Dar Es Salaam, Tanzania.
Manthomeng MateteMonitoring, Evaluation and Research Division, Jhpiego, Maseru, Lesotho.
Griffiths KubekaThe Aurum Institute, Johannesburg, South Africa.
Lindiwe TsopeThe Aurum Institute, Johannesburg, South Africa.
Rachel MukoraThe Aurum Institute, Johannesburg, South Africa.
Don MudzengiThe Aurum Institute, Johannesburg, South Africa.
Tanya NielsonThe Aurum Institute, Johannesburg, South Africa.
Knut LönnrothKarolinska Institutet, Stockholm, Sweden.
Stefan NiemannResearch Center Borstel, Center for Medicine and Biosciences, Borstel, Germany.
Molebogeng RangakaInstitute for Global Health, University College London, London, UK.
Kavindhran VelenThe Aurum Institute, Johannesburg, South Africa.
Salome CharalambousThe Aurum Institute, Johannesburg, South Africa.
Stacie Stender *, Jhpiego, Baltimore, MD, USA.
Lilian Tina Minja *Mbeya Medical Research Centre, National Institute for Medical Research, Dar Es Salaam, Tanzania.

Funding

European and Developing Countries Clinical Trials Partnership 2 RIA2019IR-2877 - CUT TB
6 · The paper itself

Abstract

backgroundTuberculosis (TB) symptom screening and testing using either smear microscopy or GeneXpert MTB/RIF Ultra (Xpert Ultra) have been the mainstay for diagnosing TB disease in case finding. Reliance on symptom-based TB screening results in missed TB cases, and universal TB testing approach might be more suitable to find missing TB cases in high-risk populations. Universal TB testing involves testing for TB disease regardless of TB symptoms in those at risk of TB. However, limited evidence exists to support its adoption including cost-effectiveness. In this study, we will evaluate the effectiveness of universal TB testing for detection of TB and uptake of TB preventive therapy (TPT) among eligible household and community contacts in high TB settings as per country guidelines.

methodsThis is a pragmatic cluster-randomised trial conducted in Lesotho and Tanzania. Drug-sensitive TB (DS-TB) index patients aged ≥ 18 years, who have at least one contact, will be enrolled if they are microbiologically confirmed with TB within ≤ 6 weeks of diagnosis at the time of recruitment by study team at health facilities in selected districts or regions. Each TB index patient and their contact(s) will be randomised into either universal TB testing or standard TB screening arms. Household and community contacts listed by each TB index case will be enumerated and invited to participate in the study after providing informed consent or assent during household visits. The study has four sub-studies including health economics and modelling, paediatrics, microbiology, and socio-behavioural. A preparatory cross-sectional study will be conducted before delivery of the pragmatic cluster-randomised trial. It will determine the prevalence of TB infection (TBI), TPT eligibility in household contacts (HHCs), and compare the performance of QuantiFERON-TB-Gold-Plus (QFT-Plus) and QIAreach for diagnosing TBI among HHCs of TB index patients. Cluster-randomised trial and community contact tracing will be conducted in phase II. SIGNIFICANCE: This trial will provide evidence for a more intensive approach which is hypothesised to increase cost-effectiveness of TB case finding. In addition, it will provide evidence for high TB burden countries with inherently different cost structures compared to intermediate and low burden settings where previous cost-effectiveness analyses have been undertaken. CLINICAL TRIAL REGISTRATION NUMBER: BMC Trial Registry ISRCTN10003903. Registered on December 22, 2020. Protocol version number and date. Version 1.2, dated 15 January 2023. Date recruitment began. 1 March 2022. Estimated date of recruitment completion. 31 July 2025.

Indexed as

Contact TracingMass ScreeningMycobacterium tuberculosisTuberculosis, PulmonaryCost-Benefit AnalysisHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicPredictive Value of TestsRandomized Controlled Trials as TopicTanzaniaHigh TB burdenHousehold contactsHousehold contact tracingTB preventive therapyTuberculosisTuberculosis infectionUniversal TB testing

Identifiers

PMID40790601
PMCPMC12341147

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.