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CTRI Number  CTRI/2023/08/056299 [Registered on: 09/08/2023] Trial Registered Prospectively
Last Modified On: 08/08/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Process of Care Changes
Behavioral 
Study Design  Other 
Public Title of Study   Reducing TB in saharia dominated districts in India 
Scientific Title of Study   Implementation Research project to demonstrate reduction of tuberculosis in Saharia Tribe dominated region in India’ 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manjula Singh 
Designation  Scientist F 
Affiliation  Indian Council of Medical Research, New Delhi, India 
Address  Room No 311, 2nd FloorECD, ICMR Hqs. , Ansari Nagar, Delhi
Room No 311, ECD, 2nd Floor,ICMR Hqs. Ansari Nagar, Delhi
South West
DELHI
110096
India 
Phone  9868245793  
Fax    
Email  drmanjulasb@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Manjula Singh 
Designation  Scientist F 
Affiliation  Indian Council of Medical Research, New Delhi, India 
Address  Room No 311, 2nd Floor, ECD, ICMR Hq. Ansari Nagar, Delhi
Room No 311, 2nd Floor, ECD, ICMR Hqs. Ansari Nagar, Delhi
South West
DELHI
110096
India 
Phone  9868245793  
Fax    
Email  drmanjulasb@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manjula Singh 
Designation  Scientist F 
Affiliation  Indian Council of Medical Research, New Delhi, India 
Address  Room No 311, 2nd Floor, ECD, ICMR Hq. Ansari Nagar, Delhi
Room No 311, 2nd Floor, ECD, ICMR Hq. Ansari Nagar, Delhi
South West
DELHI
110096
India 
Phone  9868245793  
Fax    
Email  drmanjulasb@gmail.com  
 
Source of Monetary or Material Support  
ICMR Hq. New Delhi 
 
Primary Sponsor  
Name  ICMR 
Address  V Ramalingaswami Bhawan, Ansari Nagar, Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prabha Desikan  BMHRC, BHopal  BMHRC, Bhopal
Bhopal
MADHYA PRADESH 
9425017316

prabhadesikan@yahoo.com 
Dr Manju Toppo  Gandhi Medical college  Prof, Department of Community Medicine, GMC, Bhopal
Bhopal
MADHYA PRADESH 
9993113042

drmanjutoppo@gmail.com 
Dr Manjula Singh  ICMR Hqs.  Room no 311, 2nd Floor, ECD, ICMR Hqs new Delhi
South West
DELHI 
9868245793

singhmanjula.hq@icmr.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
BMHRC Institutional Ethics Committee  Approved 
ICMR-NIMS Ethics Committee on human research  Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  The population of the selected area including any symptomatuc or health household contact of TB patient would be screened 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Handheld xray Molecular test for TB Ready to use therapeutic food (RUTF) Food supplement Tele-OPD   Hand-held X-ray and molecular test-18-24 months Ready to use therapeutic food (RUTF)- 3 months Tele-OPD- 18-24 months  
Comparator Agent  Not Applicable  Not applicable 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  The entire population of the selected blocks including both Saharia and non-Saharia of the selected districts will be covered and the symptomatic screening will be done to identify all presumptive PTB and EPTB case
The contacts of the already identified cases will be screened for TB 
 
ExclusionCriteria 
Details  Donot agree to give sputum or for X-ray 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome
- Reduction in occurrence of number of new confirmed TB cases in selected blocks over a period of time as compared to previous years
- Reduction in occurrence of number of new confirmed TB cases over a period of time after 6 months of intervention till one year
 
6 months, 12 months, 18 months and 24 months 
 
Secondary Outcome  
Outcome  TimePoints 
- Reduction in number of notified TB cases as registered in Nikshay over a period of time
- Difference in reduction of TB cases in Saharia & non-Saharia population over a period of time
- Identifying reasons for delay in diagnosis & treatment of TB cases and initiation of preventive therapy
- Impact of Tele-OPD in identification of TB cases and general health care
- Establishing the sustainable model for continued implementation of the acceptable and successful strategies of the project.
 
one year
two years 
 
Target Sample Size   Total Sample Size="70888"
Sample Size from India="70888" 
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)   18/08/2023 
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 Applicable 
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 is an implementation research project aiming to assess impact of  innovative operational strategies on the occurrence of tuberculosis (TB) in Saharia dominated district of Madhya Pradesh and to establish mechanism and processes for enhanced and early testing and treatment of tuberculosis cases and preventive of contacts. The will be undertaken in 8 Saharia Tribe dominated districts in Madhya Pradesh and involves the qualitative component to identify reasons for the delay in diagnosis & initiation of TB treatment and delay in TPT initiation. After baseline prevelance and rapid situational analysis, in each district, the interventions will be initiated which includes intense IEC activities followed by active case detection by field teams using handheld x-rays for screening and molecular test for diagnosis and all the cases would be treated as per NTEP guidelines by District TB cell. ASHAs, village volunteers, would be responsible for ensuring treatment adherence to decrease unfavourable outcomes and to increase awareness. All the contacts would be screened to rule out TB and would be initiated on TPT. The vulnerability mapping will be done and the co-morbid conditions would be referred for appropriate management. For the smoking and alcohol cessation, the patients would be referred to NCD division of programme. The nutritional interventions for malnutrition and IFA, deworming would be done for all eligible participants.  The tele-OPD will be initiated for consultation & appropriate advice to symptomatics. The endline survey will be done at the end of the intervention. The proposed interventions in the entire saharia dominated blocks which would cover both Saharias and non-Saharia population will have impact on the occurrence of the TB cases in the entire region, thus leading to substantial reduction of TB in Saharia population. This will help in development of the suitable policy for the Saharia tribe.

 
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