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CTRI Number  CTRI/2025/12/099915 [Registered on: 29/12/2025] Trial Registered Prospectively
Last Modified On: 24/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   The role of awareness programs in encouraging adults to take the Human papilloma virus vaccine. 
Scientific Title of Study   Effect of health education on influencing acceptance and uptake of Human Papilloma Virus vaccination among adult men and women. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jyothi G S 
Designation  Professor & HOD 
Affiliation  Ramaiah Medical College 
Address  Dept of Obstetrics & Gynecology Ramaiah Medical College MSRIT Post Mathikere Bengaluru

Bangalore
KARNATAKA
560054
India 
Phone  9845257772  
Fax    
Email  drjyothimsrmc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sandeep Sreerama Reddy 
Designation  Assistant Professor 
Affiliation  Ramaiah Medical College 
Address  Dept of General Medicine Ramaiah Medical College MSRIT Post Mathikere Bengaluru

Bangalore
KARNATAKA
560054
India 
Phone  9886678744  
Fax    
Email  ssreddy.dr@outlook.com  
 
Details of Contact Person
Public Query  
Name  Sandeep Sreerama Reddy 
Designation  Assistant Professor 
Affiliation  Ramaiah Medical College 
Address  Dept of General Medicine Ramaiah Medical College MSRIT Post Mathikere Bengaluru

Bangalore
KARNATAKA
560054
India 
Phone  9886678744  
Fax    
Email  ssreddy.dr@outlook.com  
 
Source of Monetary or Material Support  
MSD PHARMACEUTICALS PVT LTD 
 
Primary Sponsor  
Name  MSD PHARMACEUTICALS PVT LTD 
Address  WEWORK Enam Sambhav levels 7 8 9 C20 G block BandraKurla Complex Mumbai 400051  
Type of Sponsor  Pharmaceutical industry-Global 
 
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 JYOTHI G S  RAMAIAH MEDICAL COLLEGE HOSPITAL  ROOM NO 27, MEDICINE OPD, MSRIT POST, MSR NAGAR, MATHIKERE, BENGALURU
Bangalore
KARNATAKA 		 9845257772

drjyothimsrmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MSRMC Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Knowledge Attitude and Practices on Human Papilloma Virus Vaccination 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Health education relating to Human Papilloma Virus infection, related diseases, and vaccination  The participants will be enrolled into any one of the educational intervention groups implementing through Informative leaflets, Educational videos or direct interaction with a Patient Counsellor 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants willing to give informed consent
Participants with age 18yrs and above who attend the out-patient clinics or have been admitted at Ramaiah Medical Teaching Hospitals 
 
ExclusionCriteria 
Details  Participants who have received HPV vaccination earlier
Participants who have already suffered from any known HPV-related disease 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the determinants of willingness, acceptance, of HPV vaccination among adult men and women  4 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the impact of different communication strategies on HPV vaccination willingness & uptake  4 WEEKS 
 
Target Sample Size   Total Sample Size="1100"
Sample Size from India="1100" 
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)   12/01/2026 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary   HPV infection is one of the most prevalent sexually transmitted infections globally with significant implications for public health due to its association with various cancers and genital warts. While much of the existing literature has focused on young girls and adolescent vaccination, there is a growing need to understand the unique determinants of vaccination behavior among adult male and female populations. This study will aim to investigate the willingness, acceptance, key determinants, and uptake of HPV vaccination in adult men and women with the age groups of 18 years and above. 

All enrolled participants will complete a pre-validated, questionnaire in the local languages of Kannada, Telugu, Tamil, Hindi, and English to assess the knowledge of the Human Papilloma Virus and perceived risk for related diseases, perceived barriers, attitude and awareness about HPV Vaccination and its role in preventing cervical cancer. Descriptive norms, health literacy, previous health behaviors and other covariates of socio-demographics will also be captured. The enrolled participants will then be randomly stratified into any one of the educational intervention groups implementing through a) Informative leaflets, b) Educational videos, or c) Direct interaction with a Patient Counsellor relating to HPV infection, related diseases, and vaccination. They will be followed up within a week, recapturing the same set of questionnaires to assess the improvement in their knowledge-attitude-practice parameters.

By leveraging insights from behavioral science, the study will also explore the different delivery systems or points of vaccination and communication strategies. Understanding these factors is critical for designing effective interventions to enhance HPV vaccination rates and subsequently reduce HPV-related morbidity and mortality.
 
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