LOCATE-TB

Primary objective:

Assess the operational feasibility and acceptability of use of Truenat MTB Plus and MTB-RIF Dx testing on the Molbio Truenat platform within a mobile TB active case finding service in Yogyakarta, Indonesia.

Secondary objectives:

For bacteriologically confirmed tuberculosis cases, compare time to result for individuals diagnosed using decentralised Truenat MTB Plus and MTB-RIF Dx against time to result for individuals diagnosed using centralised geneXpert testing.

Compare the time to treatment commencement for decentralised Truenat MTB Plus and MTB-RIF Dx to centralised Xpert testing.

2023-ongoing

The operational feasibility of point-of-care testing using the Truenat equipment will be assessed by the adequacy of Truenat training post-training assessment, the operational performance of Truenat equipment by failure and error rates, and user and health service provider acceptability and participants acceptability of point-of-care testing.

This study will compare whether point of care testing with a battery operated molecular TB test (Molbio Truenat) helps diagnose people with TB disease and link them to starting on treatment sooner than the current approach of collecting samples that are transported to a central laboratory for later testing. The study randomises different days of screening to either be point-of -care testing days or central testing days in order to be able to assess the two different strategies.

Referral of sputum specimens centrally leads to delays in diagnosis and required extra visits from healthcare workers to follow-up and contact patients with TB. Provision of point-of-care testing capacity within the mobile screening service could reduce diagnostic delays and increase acceptability. Inclusion of Truenat system and MTB assays within household contact tracing would allow diagnosis of active TB disease and support TB infection diagnosis and allow more rapid advice to the family and close contacts of index cases.