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Evaluating point of care test to identify non-adherence to tuberculosis medications

Evaluating urine isoniazid testing for tuberculosis disease in India to detect medication nonadherence and improve treatment outcomes - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076117
Enrollment
900
Registered
2024-11-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: A150- Tuberculosis of lung

Interventions

Intervention1: Urine isoniazid testing: At routine monthly clinic visits during TB treatment and during unannounced home visits, the researchers will assess medication adherence using the Isoscreen te

Sponsors

ICMR National Institute for Research in Tuberculosis
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria will be: (a) 18+ years of age, (b) presumed or confirmed drug-susceptible pulmonary TB (with or without a previous TB history), and (c) taking an isoniazid-containing TB regimen.

Exclusion criteria

Exclusion criteria: Exclusion criteria will include: (a) inability to provide informed consent, and (b) drug-resistant TB diagnosis or switch to another non-isoniazid-containing regimen. As drug-resistant TB diagnosis or regimen switches occur weeks into therapy, these will result in retrospective exclusion.

Design outcomes

Primary

MeasureTime frame
Composite of: (1) loss to follow-up during TB treatment, (2) TB treatment failure, death during the on-treatment or post-treatment period, and (4) TB recurrence.Timepoint: Outcomes will be assessed during TB treatment and during 12 months of follow-up after completion of TB treatment

Secondary

MeasureTime frame
Each of the following individual outcomes will be evaluated alone as a secondary outcome: (1) loss to follow-up during TB treatment, (2) TB treatment failure, (3) death during the on-treatment or post-treatment period, (4) TB recurrenceTimepoint: Outcomes will be assessed during TB treatment and during the 12 months of follow-up after completion of TB treatment

Countries

India

Contacts

Public ContactDr Karikalan Nagarajan

ICMR National Institute for Research in Tuberculosis

karikalan.n@icmr.gov.in7299226582

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026