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CTRI Number  CTRI/2025/03/082206 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 01/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational Intervention Program]  
Study Design  Single Arm Study 
Public Title of Study   Impact of Educational Program on Nursing Students knowledge and Attitudes Toward HPV Vaccination 
Scientific Title of Study   Evaluation of the role of the educational program in shaping nursing students Knowledge and attitudes towards HPV vaccine 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Booja Sri R V  
Designation  2nd year MBBS 
Affiliation  Indira Gandhi Medical College and Research Institute  
Address  Indira Gandhi Medical College and Research Institute, Kathirkamam, Puducherry, India

Pondicherry
PONDICHERRY
605009
India 
Phone  8825462116  
Fax    
Email  boojasriv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rupa Vani Kollipaka  
Designation  Associate Professor , Department of Obstetrics and Gynaecology  
Affiliation  Indira Gandhi Medical College and Research Institute  
Address  Department of Obstetrics and Gynaecology, Indira Gandhi Medical College and Research Institute Kathirkamam, Puducherry, India

Pondicherry
PONDICHERRY
605009
India 
Phone  9003550554  
Fax    
Email  obgrupa@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rupa Vani Kollipaka  
Designation  Associate Professor , Department of Obstetrics and Gynaecology  
Affiliation  Indira Gandhi Medical College and Research Institute  
Address  Department of Obstetrics and Gynaecology, Indira Gandhi Medical College and Research Institute, Kathirkamam, Puducherry, India

Pondicherry
PONDICHERRY
605009
India 
Phone  9003550554  
Fax    
Email  obgrupa@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Medical College and Research Institute, Pondicherry 605009, India  
 
Primary Sponsor  
Name  Booja Sri  
Address  Indira Gandhi Medical College and Research Institute, Pondicherry 605009, India  
Type of Sponsor  Other [Self] 
 
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 Rupa Vani Kollipaka   Indira Gandhi Nursing College   Kathirkamam, Puducherry 605009
Pondicherry
PONDICHERRY 		 9003550554

boojasriv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indira Gandhi Medical College and Research Institute, Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Assessing knowledge about HPV vaccination among nursing students pre and post educational intervention 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Educational Intervention  As it is a quasi-experimental design, the comparison is made between the pre and post intervention results among the same participants  
Intervention  Educational Intervention  The educational session will take the form of a seminar, followed by an interactive Question and Answer session with the students. The seminar will cover the following topics: the prevalence and burden of HPV infection, methods of HPV transmission and associated risk factors, how HPV infection can progress to cervical cancer, the types of HPV vaccines available in India, guidelines for their storage and administration, their safety and efficacy, common myths and beliefs that hinder vaccination, and the current dosing schedule recommendations according to CDC guidelines. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Students enrolled in 2nd and 3rd year in Indira Gandhi Nursing College, Puducherry
Students who are 18 years of age or older and have consented for the study  
 
ExclusionCriteria 
Details  less than 18 years of age, and individuals not willing to participate or unable to provide informed consent  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of the change in knowledge about HPV and its vaccination among nursing students following an educational intervention  Assessment of the change in knowledge about HPV and its vaccination among nursing students-immediately after and 4 weeks following the intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Assessing the baseline knowledge and attitudes towards HPV vaccination, measure the changes following the intervention.  Measuring changes in knowledge and attitudes 4 weeks following intervention 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   17/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/03/2025 
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   N/A 
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
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  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 - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (not yet decided).

  6. For how long will this data be available start date provided 02-02-2025 and end date provided 02-06-2030?
    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  

This study aims to assess the effect of an educational program on nursing students’ knowledge and attitudes toward HPV vaccination, conducted in Indira Gandhi Nursing College, Puducherry. Using a quasi-experimental design with pre- and post-test assessments, it evaluates changes in students’ understanding and views following an interactive seminar. The findings aim to enhance future nurses’ ability to advocate for and promote HPV vaccination in clinical settings.

 
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