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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12623000718640
Ethics application status
Approved
Date submitted
22/06/2023
Date registered
5/07/2023
Date last updated
5/07/2023
Date data sharing statement initially provided
5/07/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
National Tuberculosis Prevalence Survey of Timor-Leste
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Scientific title
National Tuberculosis Prevalence Survey of Timor-Leste
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Secondary ID [1]
309954
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None
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Universal Trial Number (UTN)
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Trial acronym
NTPS-TL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tuberculosis
330437
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Condition category
Condition code
Public Health
327283
327283
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0
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Epidemiology
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Infection
327284
327284
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0
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Studies of infection and infectious agents
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Respiratory
327359
327359
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Participants will be screened for pulmonary tuberculosis at a single point in time. Screening will consist of a chest x-ray which will be automatically assessed for evidence of pulmonary tuberculosis by the CAD4TB software platform, and a short symptom screening interview to identify the presence of possible TB symptoms (cough >2 weeks, fever, weight loss, night sweats).
Participants who have radiological evidence of pulmonary tuberculosis (CAD4TB propensity score >60) and/or one or more TB symptoms will be eligible for sputum collection. These participants will be asked to provide two sputum samples collected >1 hour apart.
Sputum samples will be tested by GeneXpert Ultra, with those testing positive for TB, going on for mycobacterium liquid culture confirmatory testing.
Any participant in whom symptoms or radiological evidence of TB is identified, will be referred to their local community health centre for further investigation and treatment.
The complete screening process takes approximately 10-20 minutes.
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Intervention code [1]
326374
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Early Detection / Screening
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Culture confirmed pulmonary tuberculosis, based on results of mycobacteria growth indicator tube testing
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Assessment method [1]
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Timepoint [1]
335159
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At time of screening
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Secondary outcome [1]
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Bacteriologically confirmed pulmonary tuberculosis, based on results of GeneXpert Ultra MTB
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Assessment method [1]
423320
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Timepoint [1]
423320
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At time of screening
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Eligibility
Key inclusion criteria
Persons aged 15 years and older, who have been living in a randomly selected survey cluster for at least two weeks prior to screening, and who are able to provide signed consent to participate.
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Minimum age
15
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Children and adolescents aged less than 15 years of age
Not residing in one of the selected survey cluster areas for at least two weeks prior to the survey
Residents of congregate settings including boarding schools, college dormitories, correctional facilities and hospital inpatients
Unable to provide informed consent to participate in the survey
Unable to participate in screening activities due to serious illness or incapacitation
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Random sample
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Timing
Prospective
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Statistical methods / analysis
Randomised cluster survey methodology will be used, with population proportionate to size sampling. Target sample size is determined to be 20,068 individuals, surveyed from 50 randomly selected clusters. This sample size is equivalent to approximately 2.8% of the national population aged 15 years and older. Sample size calculation is based on guidance from the WHO Tuberculosis Prevalence Survey Handbook.
Cluster size has been set at 400 persons per cluster and assumptions used for the purpose of calculating sample size include:
- Estimated population prevalence of 801 cases per 100,000, based on official WHO estimates of prevalence in Timor Leste in 2019.
- Age distribution of 63.17% of the population being aged 15 years and older,
- A coefficient of between cluster variation (k) of 0.5
- Design effect of 2.28
- Participation rate of 85%
Estimation of pulmonary TB prevalence will utilise both cluster level and individual level analyses, For cluster level analysis, TB prevalence among survey participants is calculated separately for
each cluster, and the average cluster-level prevalence is calculated. For individual level analysis, several logistic regression models will be constructed, with and without multiple imputation. Models included in the analysis will be: robust standard errors (Model 1), robust standard errors with missing value imputation (Model 2), random-effects logistic regression (Model 3), random-effects logistic regression with missing value imputation (Model 4), and robust standard errors with missing value imputation (for individuals eligible for sputum examination), and inverse probability weighting (Model 5).
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
19/09/2022
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Date of last participant enrolment
Anticipated
30/11/2023
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Actual
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Date of last data collection
Anticipated
31/01/2024
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Actual
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Sample size
Target
20068
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Accrual to date
9149
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Final
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Recruitment outside Australia
Country [1]
25605
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Timor-Leste
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State/province [1]
25605
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Australian Department of Foreign Affairs and Trade
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Address [1]
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RG Casey Building
John McEwen Crescent
Barton ACT 0221 Australia
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Country [1]
314131
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Australia
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Primary sponsor type
Other
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Name
Menzies School of Health Research
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Address
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
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Country
Australia
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Secondary sponsor category [1]
316049
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Government body
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Name [1]
316049
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Timor-Leste Ministério da Saúde
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Address [1]
316049
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Dili
Timor-Leste
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Country [1]
316049
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Timor-Leste
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313266
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Human Research Ethics Committee of NT Health and Menzies School of Health Research
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Ethics committee address [1]
313266
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Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
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Ethics committee country [1]
313266
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Australia
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Date submitted for ethics approval [1]
313266
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09/11/2021
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Approval date [1]
313266
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03/12/2021
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Ethics approval number [1]
313266
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2021-4208
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Ethics committee name [2]
313269
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Instituto Nacional De Saude
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Ethics committee address [2]
313269
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Rua de Comoro
Dili
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Ethics committee country [2]
313269
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Timor-Leste
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Date submitted for ethics approval [2]
313269
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26/11/2021
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Approval date [2]
313269
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25/07/2022
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Ethics approval number [2]
313269
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1306MS-INS/DE/VII/2022
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Summary
Brief summary
The National TB Prevalence Survey of Timor Leste is a cross-sectional randomised cluster survey to assess the prevalence of pulmonary tuberculosis in persons aged 15 years and older in Timor Leste. Survey participants will be screened for tuberculosis using a combination of symptom screening and chest x-ray with bacteriological testing by rapid molecular test and mycobacterial culture. Results of the survey will be used to update estimates of Timor Leste’s burden of tuberculosis, including incidence, prevalence and mortality.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Christopher Lowbridge
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Address
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Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
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Country
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Australia
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Phone
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+61889468411
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Christopher Lowbridge
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Address
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Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
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Country
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Australia
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Phone
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+61889468411
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Christopher Lowbridge
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Address
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Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
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Country
127540
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Australia
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Phone
127540
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+61889468411
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Fax
127540
0
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Email
127540
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Ethical approval for data sharing has not been obtained
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
National cross-sectional cluster survey of tuberculosis prevalence in Timor-Leste: a study protocol
2024
https://doi.org/10.1136/bmjopen-2023-079794
N.B. These documents automatically identified may not have been verified by the study sponsor.
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