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CTRI Number  CTRI/2021/12/038890 [Registered on: 23/12/2021] Trial Registered Prospectively
Last Modified On: 22/12/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Challenges in COVID vaccination as perceived by TB patients and Stakeholders in Chennai: Qualitative study 
Scientific Title of Study   Exploration of TB patients’ and stakeholders’ challenges in COVID-19 Vaccination among Tuberculosis (TB) patients registered under National Tuberculosis Elimination Program (NTEP) in Chennai: A Qualitative study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Muthukumar R 
Designation  Assistant Professor  
Affiliation  Sri Ramachandra Medical College and Research Institute Chennai 
Address  Department of Community Medicine Sri Ramachandra Medical College and Research Institute Chennai

Chennai
TAMIL NADU
600116
India 
Phone    
Fax    
Email  drmuthu20@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Muthukumar R 
Designation  Assistant Professor  
Affiliation  Sri Ramachandra Medical College and Research Institute Chennai 
Address  Department of Community Medicine Sri Ramachandra Medical College and Research Institute Chennai


TAMIL NADU
600116
India 
Phone    
Fax    
Email  drmuthu20@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Muthukumar R 
Designation  Assistant Professor  
Affiliation  Sri Ramachandra Medical College and Research Institute Chennai 
Address  Department of Community Medicine Sri Ramachandra Medical College and Research Institute Chennai


TAMIL NADU
600116
India 
Phone    
Fax    
Email  drmuthu20@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Medical College and Research Institute Chennai 600116 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [nil] 
 
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 
Dr Muthukumar R  Sri Ramachandra Medical College and Research Institute, Chennai  Department of Community Medicine, SRMC & RI, Chennai
Thiruvallur
TAMIL NADU 		 9486194199

drmuthu20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: A150||Tuberculosis of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  TB patients on treatment under National Tuberculosis Elimination Program residing in Vayalanallur village in Tiruvallur district, Tamilnadu 
 
ExclusionCriteria 
Details  Unwilling participants 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Deeper insights about the challenges in COVID-19 Vaccination among Tuberculosis (TB) patients registered under National Tuberculosis Elimination Program (NTEP) in Chennai  at the time of data collection 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   24/12/2021 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drmuthu20@gmail.com].

  6. For how long will this data be available start date provided 01-05-2022 and end date provided 01-05-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Despite being curable and having uniform treatment schedule from government, Tuberculosis continues to be the number one killer disease among infectious disease worldwide. While TB was a common co-infection among HIV, now it got a more lethal companionship from COVID-19. The rates of pulmonary complications and death among TB patients will remain high if co-infected with TB unless we intervene the barriers of compliance to the COVID-19 vaccine. This study has been designed to understand barriers of COVID-19 vaccination among TB patients from perspectives of both patients and NTEP program stakeholders.

 
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