PROJECT

Evaluating urine isoniazid testing for tuberculosis disease in India to detect medication non adherence and improve treatment outcomes.

January 2026 - --

Objectives:

To assess the agreement between urine test results collected at scheduled clinic in comparison to unannounced home visits.
To assess the relationship between non adherence by urine testing and subsequent TB outcomes.
To identify reasons for non-adherence and enablers of optimal adherence across the TB treatment course.
To identify implementation factors to inform enhanced use of urine testing into routine care.

Study Overview:

This translational research aims to develop an innovative but pragmatic strategy for early identification of TB non adherence that is feasible in LMICs with a high TB burden. The study will enroll a cohort of people starting drug-susceptible TB therapy for understanding the urine test’s performance for detecting non adherence and its predictive value for TB outcomes when implemented at scheduled clinic visits could facilitate scale-up in routine care.

Study Approach:

To integrate urine test evaluation in routine care, the study design triangulates data collection for all four aims in the same cohort study, which enhances feasibility, efficiency, and scientific rigor. After a participant enrolls, the first six months—from treatment initiation to completion—will focus on data collection for Aim 1 (urine testing in clinic and home), Aim 3 (interviews with urine-test-negative participants to understand non adherence), and Aim 4 (interviews with participants to understand perspectives on urine testing). Subsequent follow-up—up to 12 months post treatment—will focus on data collection for Aim 2 (post-treatment outcomes) and Aim 4 (interviews with providers and policymakers).

Expected Public Health Impact:

Findings will provide evidences on the qualitative assessment of urine INH tests by healthcare providers at the point-of-care to provide an immediate actionable marker of a person’s behavioural risk (i.e., non-adherence) for poor TB outcomes during pragmatic in program settings (i.e., a “behavioural biomarker”). Evidences will also provide guidance on using urine testing is to triage non-adherent people with TB as part of an adaptive TB differentiate care strategy, which has potential to improve TB outcomes in India and globally.