Evaluating Urine Isoniazid Testing to Detect Nonadherence to Tuberculosis Medications in India

NANot yet recruitingINTERVENTIONAL
Enrollment

900

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2028

Conditions
Tuberculosis, PulmonaryMedication Adherence
Interventions
DIAGNOSTIC_TEST

Urine isoniazid testing (IsoScreen test)

Developed by Arkansas' Public Health Service in the 1970s, this test detects metabolites of isoniazid, a drug present in drug-susceptible TB regimens. IsoScreen (GFC Diagnostics, UK) is a commercial version of the Arkansas method with reagents enclosed in a plastic vial, into which 2mL of urine can be injected with a syringe. If the urine contains isoniazid, reagents turn purple/blue (suggesting a dose was taken in the last 24 hours or appropriate adherence) or green (suggesting a dose was taken 24-48 hours before or one missed dose). A yellow result (no color change) suggests medication has not been taken for \>48 hours (two or more missed doses).

All Listed Sponsors
collaborator

Tuberculosis Research Centre, India

OTHER_GOV

collaborator

Massachusetts General Hospital

OTHER

lead

Tufts University

OTHER

NCT06526221 - Evaluating Urine Isoniazid Testing to Detect Nonadherence to Tuberculosis Medications in India | Biotech Hunter | Biotech Hunter