Test and Treat to End Tuberculosis (TB): A screening and treatment study for children and adults with Latent Tuberculosis Infection (LTBI)
Test and Treat to End Tuberculosis (TB): Investigating the effect of a screening for, and treatment of, latent TB infection (LTBI) in the general population on the prevalence of TB in that population.
Woolcock Institute of Medical Research
208,000 participants
Apr 4, 2022
Interventional
Conditions
Summary
This study is community-based cluster-randomised controlled trial of universal testing and treatment for latent TB infection, together with active case finding for TB disease, to reduce the prevalence of TB disease. The primary objective of the study is to estimate, among people aged 15 years and over living in Ca Mau Province, southern Vietnam, the effect of universal testing for and treatment of latent TB infection, together with active case finding for TB, on the population prevalence of bacteriologically-confirmed TB two years after the intervention.
Eligibility
Inclusion Criteria8
- Eligibility criteria for TEST phase
- Aged 5 years or older on the date of enumeration; AND
- Capable of giving informed consent or, if aged < 15 years, having a parent or guardian who can give consent. Assent will also be routinely sought from children aged 10 to <15 years; AND
- Not currently taking treatment for tuberculosis.
- Eligibility criteria for TREAT phase
- Meet eligibility criteria for testing and consented to screening; AND
- Tuberculin skin test (TST) reaction size >= 10mm (or > 0mm if known to be HIV +ve) AND
- Either no abnormality consistent with TB on chest radiograph OR abnormal radiograph but two sputum specimens are culture negative for M. tuberculosis
Exclusion Criteria6
- Pregnant or planning to be pregnant in next 6 months
- Important potential drug interactions with the intervention regimen, defined by attending medical officer in accordance with a schedule.
- Known allergy or hypersensitivity to the active substance or any of the ingredients of the study drugs
- Has completed a course of treatment for TB within the preceding two years.
- Serum transaminases (AST and ALT) are both >= 3 x upper limit of normal
- Severe or life-threatening illness that is considered by the attending medical officer to make treatment for LTBI inappropriate.
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Interventions
TEST phase: Screening for LTBI infection TREAT phase: Treatment of LTBI in those who screen positive for LTBI. TEST Screening for LTBI will be performed as the part if the study. Screening involves implementation of an tuberculin skin test (TST) using the Mantoux technique. A TST involves a small injection of tuberculin into the forearm. After 48-96 hours the injection site is assessed for any reaction (lump). Those with a positive TST will have a chest x-ray performed and a sputum specimen collected to screen for active TB disease. If active TB is diagnosed the person will be referred for treatment of TB. If active TB is not found, the person will be offered treatment for LTBI. TREAT People with LTBI who do not have active TB and do not meet specified exclusion criteria, will be offered treatment for LTBI with the 3HP regimen: 12 weeks of oral treatment administered once a week with isoniazid (900mg if greater than or equal to 50Kg) and rifapentine (900mg if greater than or equal to 50Kg) with sliding scale lower weight based doses for children aged between 5 years and 15 years of age weighing less than 50Kg. Wherever possible the participant will ingest the medication in front of the researcher. When this is not possible, questions about adherence will be asked by telephone or face to face interview. The treatment is administered in the form of an oral tablet.
Locations(1)
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ACTRN12622000115730