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Understanding the factors that can have an impact on treatment among TB Patients in a coastal district of Southern India.

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/10/095828
Enrollment
200
Registered
2025-10-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: A15-A19- Tuberculosis

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

ICMR - Indian Council Of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Quantitative Component: 1. 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 2. 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 3. Who are willing to provide written informed consent 4. 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 2. 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 3. Who are willing to provide written informed consent 4. Residing in the study area for treatment duration For Healthcare Providers: 1. Directly involved in TB care Healthcare Providers Medical Officers CHOs NTEP Personnel TB Field Staffs and Treatment Supervisors 2. Six months experience in TB program implementation For TB Mitras: 1. Active Mitras Currently supporting one or more NTEP registered patient 2. Former Mitras Discontinued support within the last six months

Exclusion criteria

Exclusion criteria: Quantitative component: 1. Newly diagnosed Drug-Resistant TB patients. 2. Previously treated patients (Treatment failure and Unknown) 3. TB patients co-infected with HIV 4. Severe comorbidities interfering with participation (e.g., severe mental illness, terminal illnesses). 5. Unable to provide informed consent due to cognitive impairment or other reasons. Qualitative Component: For Patients: 1. Previously treated patients (Treatment failure and Unknown) 2. TB patients co-infected with HIV 3. Severe comorbidities (e.g., advanced HIV, cancer) affecting ability to participate 4. Drug-resistant TB (DR-TB) patients For Healthcare Workers (HCWs): Nil For TB Mitras: Nil

Design outcomes

Primary

MeasureTime frame
Quantitative: Treatment outcome at 6 months: proportion of patients who are cured or have completed treatment versus unfavorable outcome. Qualitative: Identification of barriers and facilitators to scheme enrollment, adherence, and engagement (NPY, Nikshay Mitra) as experienced by patients, providers, and Mitras Thematic categories of systemic, community, and operational challenges Change in awareness, perceptions, and reasons for participation or non-participationTimepoint: Quantitative:At 6 months Qualitative: At 6 months

Secondary

MeasureTime frame
Epidemiological factors affecting treatment outcome Treatment adherence (measured by MARS-5 score) at baseline and end of treatment Rate and timing of Nikshay Poshan Yojana (NPY) benefit receipt Diagnostic delay (time from first healthcare contact to diagnosis and NTEP registration) Association of patient factors and NPY utilization with treatment outcome Awareness and participation in welfare schemesTimepoint: 0 months (enrollment), 6 months (end of treatment), 12 months (follow-up for relapse and ongoing engagement)0 months (enrollment), 6 months (end of treatment), 12 months (follow-up for relapse and ongoing engagement)

Countries

India

Contacts

Public ContactSneha D Mallya

Kasturba Medical College, Manipal, Manipal Institute of Higher Education

sneha.kamath@manipal.edu9880893371

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026