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CTRI Number  CTRI/2025/10/095828 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Mixed Method Study - Quantitative : Prospective Longitudinal Study and Qualitative 
Study Design  Other 
Public Title of Study   Understanding the factors that can have an impact on treatment among TB Patients in a coastal district of Southern India. 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pratheshwar M 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal, Manipal Institute of Higher Education 
Address  Department of Community Medicine, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Tiger Circle, Madhav Nagar, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9442237315  
Fax    
Email  pratheshwar.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Sneha D Mallya 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal, Manipal Institute of Higher Education 
Address  Department of Community Medicine, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Tiger Circle, Madhav Nagar, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9880893371  
Fax    
Email  sneha.kamath@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Sneha D Mallya 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal, Manipal Institute of Higher Education 
Address  Department of Community Medicine, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Tiger Circle, Madhav Nagar, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9880893371  
Fax    
Email  sneha.kamath@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal, Manipal Institute of Higher Education, Tiger Cir Rd, Madhav Nagar, Manipal, Karnataka 576104, India 
 
Primary Sponsor  
Name  ICMR - Indian Council Of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pratheshwar M  Kasturba Hospital and Kasturba Medical College, Manipal  Department of Community Medicine, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Tiger Circle, Madhav Nagar, Manipal, Udupi, Karnataka - 576104
Udupi
KARNATAKA 		 9442237315

pratheshwar.kmcmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A15-A19||Tuberculosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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-participation 		 Quantitative:At 6 months
Qualitative: At 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
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 schemes 		 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) 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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