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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
Scientific title
National Tuberculosis Prevalence Survey of Timor-Leste
Secondary ID [1] 309954 0
None
Universal Trial Number (UTN)
Trial acronym
NTPS-TL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis 330437 0
Condition category
Condition code
Public Health 327283 327283 0 0
Epidemiology
Infection 327284 327284 0 0
Studies of infection and infectious agents
Respiratory 327359 327359 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 326374 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335159 0
Culture confirmed pulmonary tuberculosis, based on results of mycobacteria growth indicator tube testing
Timepoint [1] 335159 0
At time of screening
Secondary outcome [1] 423320 0
Bacteriologically confirmed pulmonary tuberculosis, based on results of GeneXpert Ultra MTB
Timepoint [1] 423320 0
At time of screening

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.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
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).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/09/2022
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
31/01/2024
Actual
Sample size
Target
20068
Accrual to date
9149
Final
Recruitment outside Australia
Country [1] 25605 0
Timor-Leste
State/province [1] 25605 0

Funding & Sponsors
Funding source category [1] 314131 0
Government body
Name [1] 314131 0
Australian Department of Foreign Affairs and Trade
Country [1] 314131 0
Australia
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Country
Australia
Secondary sponsor category [1] 316049 0
Government body
Name [1] 316049 0
Timor-Leste Ministério da Saúde
Address [1] 316049 0
Dili
Timor-Leste
Country [1] 316049 0
Timor-Leste

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313266 0
Human Research Ethics Committee of NT Health and Menzies School of Health Research
Ethics committee address [1] 313266 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Ethics committee country [1] 313266 0
Australia
Date submitted for ethics approval [1] 313266 0
09/11/2021
Approval date [1] 313266 0
03/12/2021
Ethics approval number [1] 313266 0
2021-4208
Ethics committee name [2] 313269 0
Instituto Nacional De Saude
Ethics committee address [2] 313269 0
Rua de Comoro
Dili
Ethics committee country [2] 313269 0
Timor-Leste
Date submitted for ethics approval [2] 313269 0
26/11/2021
Approval date [2] 313269 0
25/07/2022
Ethics approval number [2] 313269 0
1306MS-INS/DE/VII/2022

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127538 0
Dr Christopher Lowbridge
Address 127538 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Country 127538 0
Australia
Phone 127538 0
+61889468411
Fax 127538 0
Email 127538 0
christopher.lowbridge@menzies.edu.au
Contact person for public queries
Name 127539 0
Dr Christopher Lowbridge
Address 127539 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Country 127539 0
Australia
Phone 127539 0
+61889468411
Fax 127539 0
Email 127539 0
christopher.lowbridge@menzies.edu.au
Contact person for scientific queries
Name 127540 0
Dr Christopher Lowbridge
Address 127540 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Country 127540 0
Australia
Phone 127540 0
+61889468411
Fax 127540 0
Email 127540 0
christopher.lowbridge@menzies.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval for data sharing has not been obtained


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
SourceTitleYear of PublicationDOI
Dimensions AINational cross-sectional cluster survey of tuberculosis prevalence in Timor-Leste: a study protocol2024https://doi.org/10.1136/bmjopen-2023-079794
N.B. These documents automatically identified may not have been verified by the study sponsor.