| 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
|
|
|
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
|
|
|
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
|
|
|
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. |