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

Launched by TUFTS UNIVERSITY · Jul 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help doctors identify patients with tuberculosis (TB) who may not be taking their medications as prescribed. The researchers believe that testing urine for a specific TB medication, isoniazid, could provide valuable information about whether patients are following their treatment plan. This is important because not taking medications can lead to serious health issues, like worsening TB, drug resistance, or even death. The trial aims to involve about 900 participants who are 18 years or older, have drug-susceptible pulmonary TB, and are currently taking an isoniazid-containing treatment.

Participants in this study will undergo urine testing during their scheduled clinic visits to see how accurately it reflects their medication adherence. They may also be visited at home to compare results. The goal is to better understand why some patients don’t take their medications and to find ways to support them. If you meet the eligibility criteria and choose to participate, you’ll be helping researchers find a practical solution that could improve TB care in India and potentially in other countries facing similar challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18+ years of age,
• • 2. presumed or confirmed drug-susceptible pulmonary TB (with or without a previous TB history), and
• • 3. taking an isoniazid-containing TB regimen.
• Exclusion Criteria:
• • 1. inability to provide informed consent, or
• • 2. drug-resistant TB diagnosis or switch to another non-isoniazid-containing regimen (Note that this second exclusion criteria may result in retrospective exclusion from the study).