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

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A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akinek gyógyszerre érzékeny tüdő-tuberkulózisa (TBC) van vagy azt feltételezik, és izoniazidot tartalmazó TBC-kezelést kap.

Életkor

18 év vagy idősebb

Nem

Nők és férfiak is részt vehetnek

A betegség stádiuma

Feltételezett vagy igazolt, gyógyszerre érzékeny tüdő-TBC, korábbi TBC-vel vagy anélkül

Korábbi kezelés

Izoniazidot tartalmazó TBC-kezelést kell kapnia

A részvétel fő kizáró okai

• Nem tud tájékozott beleegyezést adni
• Gyógyszerrezisztens TBC diagnózisa
• Átállás izoniazidot nem tartalmazó TBC-kezelésre

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

Tuberculosis (TB) is the leading infectious cause of death globally. India has the largest TB epidemic, accounting for one-quarter of cases and one-third of TB deaths worldwide. Nonadherence to medications is a central challenge in TB care leading to increased death, disease recurrence, and drug resistance. Despite its importance, detecting nonadherence in routine care is challenging, as current measurement approaches are inaccurate, not person-centered, or ineffective at improving outcomes. Early and accurate detection of nonadherence may serve as an entry point for differentiated care, in which people with TB at risk for poor outcomes can be given intensified interventions. Urine isoniazid testing is a validated, low-cost, point-of-care, and direct adherence measure that may be predictive of TB outcomes and therefore serve as an ideal triage test to enable differentiated care. However, to integrate urine testing into routine care, research is needed to: (1) understand how the test performs at scheduled clinic visits, (2) gain a rich understanding of root causes of nonadherence to better leverage urine test results, and (3) identify barriers and facilitators to implementation. In this study, the investigators propose conducting a 900 participant prospective cohort study with translational research involving clinical, behavioral, and implementation science to facilitate integration of urine isoniazid testing into India's national TB program. The investigators' central hypothesis is that urine testing can be integrated into routine care to facilitate early and accurate identification of people with TB who are likely to suffer poor outcomes, including death and TB recurrence. In Aim 1, the investigators will assess the accuracy of urine test results assessed at scheduled clinic visits in comparison to those assessed at unannounced home visits. In Aim 2, the investigators will assess the relationship between nonadherence detected by urine testing and subsequent unfavorable TB outcomes of death, loss to follow-up, treatment failure, and post-treatment TB recurrence.. This study proposal aims to develop an innovative but pragmatic strategy for early identification of TB medication nonadherence that is feasible in low- and middle-income countries with a high TB burden.

A vizsgálat csoportja

• Urine isoniazid testing (intervention arm)A vizsgált kezelés

  This is the only study group/arm in this study. Participants in this study arm will receive urine isoniazid testing using the IsoScreen test in the TB clinic at monthly clinical and medication refill visits at month 1, 2, 3, 4, and 5 (5 times total). The will also undergo urine isoniazid testing using the IsoScreen test at home visits after months 1, 3, and 5 of treatment (3 times total).

  Kezelés: Urine isoniazid testing (IsoScreen test)