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CTRI Number  CTRI/2022/10/046739 [Registered on: 21/10/2022] Trial Registered Prospectively
Last Modified On: 21/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Knowledge attitude and practice towards HPV vaccination 
Scientific Title of Study   An exploratory survey on knowledge, attitude and practice on Human Papilloma Virus vaccination among female allied health and pharmacy students in a tertiary care teaching hospital in coastal Karnataka 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohammed Ashique Chukkan 
Designation  PG student 
Affiliation  Manipal College of Health Professions 
Address  Department of MLT, Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka
Manipal College of Health Professions
Udupi
KARNATAKA
576104
India 
Phone  9072826389  
Fax  0  
Email  mohammed.chukkan1@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Aneena Varghese 
Designation  Assistant Professor Senior Scale 
Affiliation  Manipal College of Health Professions 
Address  Department of MLT, Manipal College of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi, Karnataka
Manipal College of Health Professions
Udupi
KARNATAKA
576104
India 
Phone  9526787947  
Fax  0  
Email  aneena.varghese@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Aneena Varghese 
Designation  Assistant Professor Senior Scale 
Affiliation  Manipal College of Health Professions 
Address  Department of MLT, Manipal College of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi, Karnataka
Manipal College of Health Professions
Udupi
KARNATAKA
576104
India 
Phone  9526787947  
Fax  0  
Email  aneena.varghese@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions 
 
Primary Sponsor  
Name  Mohammed Ashique Chukkan 
Address  Department of MLT, Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 
Type of Sponsor  Other [Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aneena Varghese  Manipal College of Health Professions  Department of MLT, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka
Udupi
KARNATAKA 		 9526787947
0
aneena.vargese@manipal.edu 
Aneena Varghese  Manipal College of Pharmaceutical Sciences  Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka
Udupi
KARNATAKA 		 9526787947
0
aneena.vargese@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Female health care students aged above 18 years from MCHP and MCOPS who have not already diagnosed or treated for carcinoma of cervix 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  • Female students aged above 18 years.
• Students from MCHP and MCOPS who have not already
diagnosed or treated for carcinoma of cervix
 
 
ExclusionCriteria 
Details  • Students with advanced stages of carcinoma cervix who have already been diagnosed and
treated. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To examine the knowledge, attitude and practices of Paramedical and Pharmacy students on cervical carcinoma screening and HPV vaccination  1 Year 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the relationship and correlation between the knowledge, attitude and total KAP scores with respect to cervical cancer, screening and immunization  6 months 
 
Target Sample Size   Total Sample Size="578"
Sample Size from India="578" 
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)   27/10/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary   The questionnaire-based cross-sectional study will start after getting permission from the institutional research committee and institutional ethics committee followed by CTRI registration. Study participants will be selected based on inclusion and exclusion criteria. A self prepared validated questionnaire will be circulated among the included subjects after obtaining informed consent. Their knowledge, attitude, and practice about screening and vaccination of HPV will be assessed using the statistical tool.  
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