Tuberculosis Infections and Infestations Tuberculosis
Conditions
Interventions
Participants attending the TB active case-finding service who screen positive for potential TB by symptoms or chest X-ray will be invited to participate in the study. A study team member will explain
Sponsors
FIND
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligibility criteria for randomised comparison: 1. People aged 12 years old or above presenting to mobile CXR-based screening in Sleman district and Yogyakarta City 2. Able and willing to consent. For adolescents aged 12-17, verbal consent as well as parental/guardian informed consent will be required Eligibility criteria operational feasibility and acceptability assessments: 1. Post-Training Assessment (Objective 1a): All laboratory staff and health care workers trained in performance of Truenat assays who consent to participate 2. Feasibility and HCW acceptability (Objective 1c): All HCWs involved in the mobile screening service who consent to participate 3. Screening participant acceptability (Objective 1d): Adults 18 years of age or older who screened positive for presumptive TB in the active case finding program within the preceding 1 week and provide informed consent; and parents and legal guardians who have a child aged 12 to 17 years that screened positive for presumptive TB in the active case finding program within the preceding 1 week and provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Unable to provide sputum 2. Currently receiving anti-TB therapy 3. Patients who are seriously ill and need to be admitted to hospital 4. Patients with potential COVID-19 referred for further assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Operational performance will be assessed through laboratory staff and health care worker Truenat proficiency assessments after initial training, and by measurement of platform error rates during the study. 2. Views on the acceptability and operational challenges of Truenat will be assessed by a survey of laboratory staff and health care workers (HCW) within the program at 21 days 3. Individual in-depth qualitative interviews will be conducted with a purposive sample of screening participants to obtain their views on the acceptability and suitability of decentralised testing using Truenat at 21 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to result for those tested with Truenat MTB Plus and MTB-RIF Dx, defined as the time from initial assessment to time of TB laboratory report completion at Zero TB mobile active case finding laboratory 2. For those with a positive result on Truenat MTB Plus or GeneXpert (standard of care) the median time from initial assessment to TB treatment initiation, defined as the initiation of the first dose of anti-TB treatment at a registered TB treatment facility | — |
Countries
Indonesia
Outcome results
None listed