| 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
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
V Ramalingaswami Bhawan, Ansari Nagar, Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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. |