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Asymptomatic TB transmission in Indonesia and South Africa

Asymptomatic TB transmission in Indonesia and South Africa

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN21883784
Enrollment
150000
Registered
2026-02-05
Start date
2026-02-16
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic TB transmission in Indonesia and South Africa Infections and Infestations

Interventions

This is a multi-country, cross-sectional study designed to assess household Mtb infection and transmission among asymptomatic (aTB) and symptomatic TB (sTB) cases and their household contacts. Communi

Sponsors

Wellcome Trust
Lead Sponsor
Gates Foundation
Collaborator

Eligibility

Sex/Gender
All
Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adolescent/Adult participants for community screening: 1. Age >15 years 2. Residence in the designated study area 3. Residence in a household with children (2-14 years) 2. Child household contacts Aged 2-14 years: 1. Household residence with an adolescent/adult participant with: 1.1. aTB-C, or 1.2. sTB-C, or 1.3. An adolescent/adult participant who has been selected as a healthy control (no TB) Adolescent/adult participant in TB screening: 1. Screening W4SS negative 2. Screening sputum Xpert positive (any grade) OR Mtb MGIT positive* OR tongue swab NAAT positive Participants with sTB-C: 1. Adolescent/adult participant in TB screening 2. Screening W4SS positive 3. Screening sputum Xpert positive (any grade) OR Mtb MGIT positive* OR tongue swab NAAT positive Participants selected as healthy controls: 1. Adolescent/adult participant in TB screening 2. Screening W4SS negative 3. Screening sputum Xpert negative; AND Mtb MGIT negative* 4. Selected as a healthy control in the Cross-sectional study of Mtb infection in households (see above) 1. Adolescent/adult participant in TB screening 2. All three sputa Xpert are negative/ ‘trace’ AND all three sputum are Mtb MGIT negative 3. Screening dCXR/CAD interpretation is “suggestive of TB” 4. Clinical assessment at phenotyping visit does not suggest a non-TB aetiology for dCXR/CAD findings and is consistent with TB-U 5. Participant did not commence TB treatment after phenotyping visit

Exclusion criteria

Exclusion criteria: Adolescent/Adult participants for community screening: 1. Unable or unwilling to consent (>18 years) 2. Unable to unwilling to assent (15-17 years) 3. Parent or guardian unwilling to consent (15-17 years) 4. Residence in a household with a participant in a TB vaccine trial (currently or previous 2 years) Child household contacts: 1. Unable or unwilling to assent (>7 years) 2. Parent/guardian unable or unwilling to consent 3. Residence in household in which any resident has been diagnosed with TB within the past 2 years 4. Residence in a household with more than one adolescent/adult with current co-prevalent TB-C 1. Participants with aTB-C ; 2. Participants with sTB-C ; 3. Participants selected as healthy controls ALL 3 groups above: 1. Unable or unwilling to consent * MGIT results returning after enrolment may result in study group re-categorisation 2. Participants who meet the study case definition for bacteriologically-unconfirmed TB (TB-U) 1. Unable or unwilling to consent to longitudinal follow-up

Countries

Indonesia, South Africa

Contacts

Public ContactNompumelelo Ngobese
nompumelelo.ngobese@ahri.org+27672732700

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026