Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia

TB remains a critical public health problem worldwide. Most of the patients with TB were from low- and middle-income countries with limited resources. A large proportion of them visited HCFs without sufficient laboratory services to diagnose TB, causing a delay in TB diagnosis and treatment. In addition, while up to half of patients with presumptive TB cannot produce adequate sputum specimens, current TB diagnostics rely on sputum-based tests. Therefore, the use of near point-of-care (nPOC) or point-of-care (POC) non-sputum-based tests can potentially provide more accessible TB diagnosis and reduce delays.

This CRCT is part of a larger series of studies within the EVIDENT Research Project in Indonesia. Based on a clinical validation study (EVIDENT work package 1) and a diagnostic yield, feasibility, and cost study (EVIDENT work package 2), the CRCT (EVIDENT work package 3) will provide evidence of the effects of implementation of a multi-component public health intervention in the intervention arm, compared to the control arm. Carefully designed clinical algorithms will be employed to incorporate the new diagnostic test, using sputum and/or tongue swab specimens, into the health services. To increase patients' attendance and utilisation of the new diagnostic test, a promotional package will be provided to clinics unable to host it and to selected pharmacies. Finally, a household contact investigation will be conducted, involving community health volunteers.

Clusters are the community health centre (CHC) catchment areas, defined as geographical areas surrounding a CHC where the TB programme is expected to be implemented. The interventions will be administered in HCFs and the community in the intervention arm, while the control arm will continue standard of care with no intervention, except for refresher training on TB case notification into the National TB Information System (locally known as Sistem Informasi Tuberkulosis or SITB) before the intervention roll-out. The primary and secondary endpoints will be assessed over the 12-month post-intervention roll-out (follow-up period), with adjustment for baseline (12-month pre-randomisation period). TB case notification data will be obtained from the National TB Information System.

In addition to the main study, several sub-studies will be conducted to assess the secondary objectives: the Patient Pathway \& Patient Costing Sub-study, the Standardised Patient Sub-study, and the Health System Costing Sub-study. The Patient Pathway \& Patient Costing study is a cross-sectional study of patients recently diagnosed with TB at the selected HCF in the intervention and control arms. In the Standardised Patient Sub-study, trained standardised patients will visit selected HCFs to present a clinical scenario and record their experiences regarding examinations, diagnostic testing, and referrals. The health system costing study will gather information on the costs of diagnosing TB in HCFs and communities in the intervention and control arms.

• Change in TB case notifications in CHC areas, who live in the area, per CHC area population [Срок оценки: The outcome is measured for the 12 months before the commencement of any study procedures and over the 12-month follow-up period, starting 6 months after the start of the intervention roll-out.]
• Change in proportion of microbiologically confirmed TB cases over all diagnosed TB cases [Срок оценки: The outcome is measured over the 12 months before the commencement of any study procedures and over a 12-month follow-up period starting 6 months after the start of intervention roll-out.]
• Difference in time to TB diagnosis from the beginning of symptoms (Patient Pathway and Patient Costing Sub-study) [Срок оценки: Up to 10 months during the follow-up period]
• Difference in time to TB diagnosis from the first visit to a formal HCF (Patient Pathway and Patient Costing Sub-study) [Срок оценки: Up to 10 months during the follow-up period.]
• Number of visits to healthcare facilities before TB diagnosis (Patient Pathway and Patient Costing Sub-study) [Срок оценки: Up to 10 months during the follow-up period.]
• Propensity to test for TB (Standardised Patient Sub-study) [Срок оценки: Up to 6 months during the follow-up period]
• Patient costs for TB diagnosis (Patient Pathway and Patient Cost Sub-study) [Срок оценки: Up to 10 months during the follow-up period.]
• TB diagnostic costs in the healthcare facilities and community settings (Health System Costing Sub-study) [Срок оценки: Up to 6 months during the follow-up period.]