| CTRI Number |
CTRI/2023/06/053750 [Registered on: 12/06/2023] Trial Registered Prospectively |
| Last Modified On: |
09/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A research cum intervention multi-centric study to strengthen National TB Elimination Programme (NTEP) |
|
Scientific Title of Study
|
A research cum intervention multi-centric study to strengthen National TB Elimination Programme (NTEP) by implementing programme guidelines for TB using novel strategies to address the various challenges faced by the programme in selected states and specific population/communities in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjula Singh |
| Designation |
Scientist-F and Overall Trail Coordinator |
| Affiliation |
Indian Council of Medical Research |
| Address |
ECD-ITRC Division Indian Council of Medical Research V. Ramalingaswami Bhawan Ansari Nagar New Delhi
New Delhi DELHI 110029
India
South
DELHI
110029
India |
| Phone |
9868245793 |
| Fax |
|
| Email |
singhmanjula.hq@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula Singh |
| Designation |
Scientist-F and Overall Trail Coordinator |
| Affiliation |
Indian Council of Medical Research |
| Address |
ECD-ITRC Division Indian Council of Medical Research V. Ramalingaswami Bhawan Ansari Nagar New Delhi
New Delhi DELHI 110029
India
South
DELHI
110029
India |
| Phone |
9868245793 |
| Fax |
|
| Email |
singhmanjula.hq@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjeet Singh Chalga |
| Designation |
Scientist-D and Principal Investigator |
| Affiliation |
Indian Council of Medical Research |
| Address |
eGovernance Cell Indian Council of Medical Research V. Ramalingaswami Bhawan Ansari Nagar New Delhi
New Delhi DELHI 110029
India
South
DELHI
110029
India |
| Phone |
9582776792 |
| Fax |
|
| Email |
chalgams.hq@icmr.gov.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V. Ramalingaswami Bhawan Ansari Nagar New Delhi |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan Ansari Nagar New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Khwairakpam Premjit Singh |
Aizawl Municipal Council |
Aizawl Municipal Council, Mizoram
Aizawl
MIZORAM |
8132089197
premjituno@gmail.com |
| Dr Sanjay Kamlakar Juvekar |
Ambegaon and Junnar |
Blocks Ambegaon and Junnar in Pune District
Pune
MAHARASHTRA |
9881057959
sanjay.juvekar@kemhrcvadu.org |
| Dr Rashmi Rodrigues |
Bangalore |
Urban slums including Migrants,Bangalore
Bangalore
KARNATAKA |
8049467000
rashmijr@gmail.com |
| Dr Sonam Spalgais |
Kingsway Camp |
Urban slums of Kingsway Camp, Delhi
New Delhi
DELHI |
9650853257
sosolrs@gmail.com |
| Dr Dhruvendra Pandey |
Ratlam |
Ratlam District, Madhya Pradesh
Ratlam
MADHYA PRADESH |
8269075295
drdhruvendrapandey@gmail.com |
| Dr Srikanta Kanungo |
Urban slums of Bhubaneswar |
Urban Slums of Bhubaneswar, Orissa
Khordha
ORISSA |
8307932643
srikantak109@gmail.com |
| Dr Md Asghar |
Ziro Valley |
Lower Subansiri District, Arunachal Pradesh
Lower Subansiri
ARUNACHAL PRADESH |
8415080242
asghar2108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| GMC Ratlam |
Approved |
| KEM Hospital Research Centre |
Approved |
| Mizoram University |
Approved |
| Rajiv Gandhi University |
Approved |
| RMRC Bhubaneshwar |
Approved |
| St. Johns Medical College |
Approved |
| VPCI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A15-A19||Tuberculosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intensified Case finding to promote early case detection, treatment adherence, contact tracing and preventive therapy through innovative approaches. The symptomatic cases identified will be referred to the nearest DOT center for diagnosis and treatment. |
Community based activities and cost effective innovative strategies will be implemented to promote early case detection, treatment adherence, contact tracing and preventive therapy through innovative approaches and the symptomatic cases identified will be referred to the nearest DOT center for diagnosis and treatment. If found Positive, their contacts will be subjected to TPT by the DOT center and the investigators will follow up to make sure of the compliance to the treatment. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Efforts will be made to include all cases as defined below:
-Participants (symptomatics/TB suspects) of all age groups and of both genders
-Contacts of TB patients on treatment since last 6 months (from Nikshay)
-All symptomatics and contacts of TB index cases
Confirmed TB cases that have not yet started TB treatment and newly diagnosed patients and not having started treatment,are also eligible for the TB elimination programme
-All patients who have been detected for any TB (EPTB) within 6 months will be included
-All contacts of TB index cases including House Hold Contact(HHC) for screening and diagnosis of any TB |
|
| ExclusionCriteria |
| Details |
All cases other than inclusion criteria, are excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Site specific additional gaps, barriers and challenges in implementation of NTEP activities in the selected district/area will be identified and other novel interventional strategies based on newly identified challenges will be developed and implemented in community to strengthen NTEP and novel case finding, treatment, adherence and preventive strategies at local level will be implemented. |
24 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reasons for perceived and enacted social stigma for TB in selected communities will be assessed and interventional strategies based in the novel identified gaps, barriers and challenges as per the community settings including migratory population will be developed. |
24 Months |
|
|
Target Sample Size
|
Total Sample Size="100000"
Sample Size from India="100000"
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)
|
19/06/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tuberculosis, one of the deadliest infectious diseases poses a major threat to public health. According to WHO 2020 Global TB report, annually 10 million new TB cases are reported, with estimated 1.5 million deaths due to TB (Harding, 2020, Global TB Report, 2020). India accounts for a staggering 27% of the global TB burden (Harding, 2020). This calls for an urgent need to focus on hastening the efforts and to adopt aggressive strategies to eradicate this Mycobacterium. India envisions elimination of tuberculosis by the year 2025 (Global TB Report, 2020). This project aims to develop a novel comprehensive model to address these challenges and demonstrate the impact of these strategies in reducing the TB incidence in the vulnerable communities/areas/settings with high burden of the disease, to achieve TB elimination target of 2025. In this project we would like to address common challenges existing in various communities/areas/settings which include Stigma, community practices that are hard to remove in-spite of counseling, health system challenges, access to health care etc, which hamper proper implementation of the national programme guidelines. New challenges that may be encountered while implementing the NTEP strategies, will be addressed in a structered manner through novel approaches, diagnosing all new cases in the defined select area at the earliest using community camps. Working closely with state TB department and with proper and early initiation of the treatment of cases and preventive therapy of the contacts and vulnerable population in the community, this project aims to break the transmission chain and achieve 60-80% reduction in incidence of TB using cost effective novel model.
|