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CTRI Number  CTRI/2022/06/043233 [Registered on: 14/06/2022] Trial Registered Prospectively
Last Modified On: 07/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Qualitative study (In-depth interview) 
Study Design  Other 
Public Title of Study   Execution of Human papillomavirus (HPV) vaccination at large in India 
Scientific Title of Study   Implementation of human papillomavirus (HPV) Vaccination at scale 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  Priyobrat Rajkhowa 
Designation  PhD Scholar 
Affiliation  Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education 
Address  Department of Health Policy (Public Health), Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal. Room No: 24 Room No: 31, PSPH, MAHE building.

Udupi
KARNATAKA
576104
India 
Phone  9508549619  
Fax    
Email  priyobratrajkhowa.11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prakash Narayanan Vasudevan Potty 
Designation  Associate Professor 
Affiliation  Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education 
Address  Department of Health Policy (Public Health), Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal. Room No: 24 Room no: 24, PSPH Building

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  prakash.nvp@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Prakash Narayanan Vasudevan Potty 
Designation  Associate Professor 
Affiliation  Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education 
Address  Department of Health Policy (Public Health), Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal. Room No: 24 Room No: 24 PSPH building.

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  prakash.nvp@manipal.edu  
 
Source of Monetary or Material Support  
Prasanna School of Public Health 
 
Primary Sponsor  
Name  Prasanna School of Public Health 
Address  Prasanna School of Public Health, Manipal Academy of Higher Education 
Type of Sponsor  Research institution 
 
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 
Priyobrat Rajkhowa  Kasturba Hospital, Manipal  Ground floor, Paediatrics OPD, Kasturba Hospital Manipal
Udupi
KARNATAKA 		 9508549619

priyobratrajkhowa.11@gmail.com 
 
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  HPV vaccine/vaccination stakeholders (irrespective of their health status) 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. HPV Vaccine/stakeholders
2. >18 years
3. Able to understand and respond in English, Hindi, Assamese, or Nagamese.
4. Biological material required: No 
 
ExclusionCriteria 
Details  1. Parents/guardians who have only male children 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A. Develop an action plan to implement HPV vaccination at scale in India  At the baseline 
 
Secondary Outcome  
Outcome  TimePoints 
B. Identify a range of knowledge, attitude, beliefs, perceived need among HPV vaccine stakeholders regarding the HPV vaccination implementation in India  At the baseline 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   20/06/2022 
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="2"
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   Cervical cancer is a major public health issue in India, resulting in a significant economic burden that is carried disproportionately by patients as out-of-pocket expenses (OOPE). The burden of cervical cancer is so high that it contributes about 122,844 cervical cancer every year. To halt these rising statistics, vaccination against the infection can curb the escalating cervical cancer as one of the preventive methods. Unfortunately, due to various circumstances, India struggles to deliver the Human papillomavirus (HPV) vaccine at scale. To provide this promising approach and develop a roadmap of activities in eliminating cervical cancer, it is indispensable to capture the stakeholders’ viewpoints of the HPV vaccine. Therefore, this study intended to include all the stakeholders of vaccination to capture their perspectives regarding the implementation of the HPV vaccine, which will aid a policy review in developing a roadmap of activities to eliminate cervical cancer as a public health issue from India. Policymakers and health service providers will be included to seek input on how introducing the HPV vaccine would impact current services and systems, which will supplement in formulating the roadmap activities for eliminating cervical cancer as a significant public health issue. 
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