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CTRI Number  CTRI/2023/02/050068 [Registered on: 24/02/2023] Trial Registered Prospectively
Last Modified On: 18/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Health awareness using Social media campaign]  
Study Design  Single Arm Study 
Public Title of Study   Are medical students ready for early TB testing? - An insight into knowledge & attitude through social media campaign among undergraduate MBBS students in Pondicherry 
Scientific Title of Study   "Effect of awareness campaign using social media on knowledge and attitude towards early tuberculosis testing among medical undergraduates from medical colleges in Puducherry, South India: A pre and post-interventional 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 Sonali Sarkar 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) 
Address  JIPMER International School of Public Health (JISPH), JIPMER Campus Rd, Dhanvantari Nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9442174663  
Fax    
Email  sarkarsonaligh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonali Sarkar 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) 
Address  JIPMER International School of Public Health (JISPH), JIPMER Campus Rd, Dhanvantari Nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9442174663  
Fax    
Email  sarkarsonaligh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dungi VV Prasad Reddy 
Designation  MPH Trainee 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) 
Address  JIPMER International School of Public Health (JISPH), JIPMER Campus Rd, Dhanvantari Nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7780603904  
Fax    
Email  drveerumph@gmail.com  
 
Source of Monetary or Material Support  
JIPMER INTRAMURAL RESEARCH FUND 
 
Primary Sponsor  
Name  JIPMER INTRAMURAL RESEARCH FUND 
Address  Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), JIPMER Campus Rd, Dhanvantari Nagar, Puducherry 
Type of Sponsor  Research institution and hospital 
 
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 Sonali Sarkar  Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)  JIPMER International School of Public Health, Dhanvantari Nagar, Puducherry
Pondicherry
PONDICHERRY 
9442174663

sarkarsonaligh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR INTERVENTIONAL STUDIES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention Package  The intervention comprises of sharing infographics, text messages, photos, and short videos with the participants through various social media platforms such as Facebook, Instagram, Linkedin, Youtube and WhatsApp that improve knowledge and change in attitude towards going for TB testing in case of having symptoms. The brief content of the intervention comprises: a) Basic facts and general information on TB testing. b) Benefits of early testing for TB c) Major risks associated with delayed diagnosis d) Medical students as an important High Risk Group (HRG) over 4 weeks. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  MBBS medical undergraduates from medical colleges from the first year to the fourth year from Puducherry 
 
ExclusionCriteria 
Details  Nil 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in the existing knowledge and change in attitude towards early testing of tuberculosis.  After the end-line data collection, 12 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Identifying the factors associated with the change in attitude towards early testing among the study participants.  After the end-line data collection, 12 weeks. 
 
Target Sample Size   Total Sample Size="2400"
Sample Size from India="2400" 
Final Enrollment numbers achieved (Total)= "613"
Final Enrollment numbers achieved (India)="613" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/02/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   In the current era of digitalization, the effective use of social media platforms to promote health education and health promotion activities is crucial and yet under-utilized. Medical students are one of the vulnerable groups with a higher chance of exposure to the undiagnosed disease of TB in the community. The early testing would assure prompt treatment and reduce morbidity and mortality associated with late diagnosis.

 
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