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CTRI Number  CTRI/2018/11/016385 [Registered on: 20/11/2018] Trial Registered Prospectively
Last Modified On: 03/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Working difficulties in tuberculosis case notification and use of NIKSHAY among the private medical practitioners in Udupi district 
Scientific Title of Study   Operational barriers to tuberculosis case notification and utilization of NIKSHAY among the private practitioners in Udupi district-A cross-sectional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Surup Dey 
Designation  Master of Public Health 3rd Semester Student 
Affiliation  Prasanna School of Public Health 
Address  Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi District

Udupi
KARNATAKA
576104
India 
Phone  7085052014  
Fax    
Email  deysurup@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Surup Dey 
Designation  Master of Public Health 3rd Semester Student 
Affiliation  Prasanna School of Public Health 
Address  Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi District

Udupi
KARNATAKA
576104
India 
Phone  7085052014  
Fax    
Email  deysurup@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr P Arathi Rao 
Designation  Assistant Professor & MPH Programme Co-ordinator 
Affiliation  Prasanna School of Public Health 
Address  Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi District

Udupi
KARNATAKA
576104
India 
Phone  9008418848  
Fax    
Email  arathimph@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Surup Dey 
Address  Prasanna School of Public Health, Manipal Academy of Higher Education, Madhavnagar, Manipal, Udupi District, Karnataka-576104 
Type of Sponsor  Other [Self] 
 
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 
Surup Dey  Prasanna School of Public Health  Department of Public Health Office, First floor Prasanna School of Public Health Building, Manipal Academy of Higher Education, Madhav nagar, Manipal
Udupi
KARNATAKA 
7085052014

deysurup@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College & Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy voluntary participants- private medical practitioners 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  23.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Private medical practitioners in Udupi district. 
 
ExclusionCriteria 
Details  Participants who are not available for interview after 3 visits attempts will be excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improve the awareness about TB case notification. Increase the utilisation of NIKSHAY reporting platform for case notification and incentives associated with it.  May 2019 
 
Secondary Outcome  
Outcome  TimePoints 
Increase the TB case notification rates among the private medical practitioners  June 2019 
 
Target Sample Size
Modification(s)  
Total Sample Size="138"
Sample Size from India="138" 
Final Enrollment numbers achieved (Total)= "138"
Final Enrollment numbers achieved (India)="138" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/12/2018 
Date of Study Completion (India) 18/03/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
Though public sector is at the forefront in providing TB care, a significant proportion of about 40% of the population seek treatment in the private sector(1). On estimation of the same through the drug sales data the estimate is 2-3 times higher. The government of India mandates TB case notification and not notifying a TB case is a punishable offence under IPC section 269 and 270. Yet despite laws and legislations being in place the case notification rates among the private practitioners remains low. The patients seeking treatment from the private practitioners if not notified will not be able to avail the incentives provided for nutritional supplementation during treatment. There is substantial evidence stating the lack of awareness and reluctance among the private practitioners towards TB case notification.
There is a need to understand the operational barriers faced by the private practitioners, if we intend to increase the TB case notification rates among them. It is also imperative to check the awareness of the private practitioners about the incentives provided for TB case notification and treatment and identify issues faced by the them in availing the incentives. This will be help in increasing the case notification by the private practitioners, eventually benefiting the patients in availing the various schemes under the Revised National Tuberculosis Control Program.
 
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