Evaluating epidemiological determinants, Treatment Adherence, and Utilization of TB specific welfare schemes and their impact on treatment Outcomes among Drug Sensitive Tuberculosis Patients: A Mixed method study

ICMR - Indian Council Of Medical Research1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2025年11月1日最近更新: 2025年10月9日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 200
试验地点: 1
主要终点: Quantitative:

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This mixed-methods study will be conducted across multiple district-level TB units. The quantitative component will enroll adult drug-sensitive TB patients (newly diagnosed or previously treated and confirmed drug-sensitive) registered under the national program and receiving care at government facilities. Key patient-level data will include sociodemographic, behavioral, and clinical factors, as well as welfare scheme participation and adherence measures. The main outcomes are treatment success rates, time to diagnosis, and benefit receipt from government schemes. Adherence (using standard scales) and utilization of patient support programs will be assessed at baseline, treatment completion, and follow-up.

The qualitative component will involve interviews and focus groups with patients, healthcare providers directly involved in TB care, and TB community volunteers (Mitras). These will explore barriers, facilitators, and operational factors influencing the use and impact of welfare schemes, adherence, and program engagement. The findings will identify system- and community-level challenges and support strategies to improve patient outcomes and program effectiveness at the district TB unit level.

研究设计

研究类型: Observational

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•Quantitative Component:
•Newly diagnosed Drug Sensitive TB patients aged 18 years and above registered under the National TB Elimination Program NTEP receiving treatment under NTEP in Government Facility
•Previously treated patients Recurrent TB and Lost to follow up cases who have been diagnosed subsequently with Drug Sensitive TB aged 18 years and above registered under the National TB Elimination Program NTEP receiving treatment under NTEP in Government Facility
•Who are willing to provide written informed consent
•Residing in the study area for treatment duration Qualitative Component: For Patients: 1.Newly diagnosed drug sensitive TB patients aged 18 years and above DS TB registered under the National TB Elimination Program NTEP receiving treatment from the Government Facility
•Residing in the study area for treatment duration For Healthcare Providers:
•Directly involved in TB care Healthcare Providers Medical Officers CHOs NTEP Personnel TB Field Staffs and Treatment Supervisors
•Six months experience in TB program implementation For TB Mitras:
•Active Mitras Currently supporting one or more NTEP registered patient
•Former Mitras Discontinued support within the last six months.

排除标准

•Quantitative component:
•Newly diagnosed Drug-Resistant TB patients.
•Previously treated patients (Treatment failure and Unknown)
•TB patients co-infected with HIV
•Severe comorbidities interfering with participation (e.g., severe mental illness, terminal illnesses).
•Unable to provide informed consent due to cognitive impairment or other reasons.
•Qualitative Component: For Patients:
•Severe comorbidities (e.g., advanced HIV, cancer) affecting ability to participate
•Drug-resistant TB (DR-TB) patients For Healthcare Workers (HCWs): Nil For TB Mitras: Nil.