| CTRI Number |
CTRI/2025/03/081969 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
HPV Vaccine: What Men in Mulki Taluk Know and Think |
|
Scientific Title of Study
|
Knowledge and Attitude about Humanpapilloma virus vaccination among men in Mulki Taluk:A cross-sectional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D Nikitha Mary Nicoba |
| Designation |
Post graduate student |
| Affiliation |
Department of Public Health K S Hegde Medical Academy (Deemed to be University) |
| Address |
Department of Public Health K S Hegde Medical Academy, Nitte (Deemed to be University), Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7899924127 |
| Fax |
|
| Email |
nikithanicoba@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reni N |
| Designation |
Assistant Professor |
| Affiliation |
Department of Public Health K S Hegde Medical Academy (Deemed to be University) |
| Address |
Department of Public Health K S Hegde Medical Academy (Deemed to be
University)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9447394613 |
| Fax |
|
| Email |
drreni.n@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reni N |
| Designation |
Assistant Professor |
| Affiliation |
Department of Public Health K S Hegde Medical Academy (Deemed to be University) |
| Address |
Department of Public Health K S Hegde Medical Academy (Deemed to be
University)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9447394613 |
| Fax |
|
| Email |
dreni.n@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Monetary support: Self funded material support Department of Public Health K S Hegde Medical Academy, Nitte (Deemed to be
University),Mangaluru,Karnataka,
India 575018 |
|
|
Primary Sponsor
|
| Name |
Dr D Nikitha Mary Nicoba |
| Address |
Department of Public Health K S Hegde Medical Academy (Deemed to be
University) Deralakatte Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Type of Sponsor |
Other [Self-funded study] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Self funded |
Department of Public Health K S Hegde Medical Academy (Deemed to be
University) Deralakatte Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D Nikitha Mary Nicoba |
K S Hegde Medical Academy |
Community based study
Deralakatte, Mangaluru, KARNATAKA 575018
Dakshina Kannada
KARNATAKA |
7899924127
nikithanicoba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC- K S Hegde Medical Academy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Men between age group 19- 45 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Males residing in Mulki since a year between the age group of 18- 45 years |
|
| ExclusionCriteria |
| Details |
Males who are immunocompromised
Males with the history of psychiatric illness within the age of 18-45years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Level of knowledge and attitude regarding HPV vaccination among men in Mulki Taluk.
Measured using a structured questionnaire.
|
Baseline survey measured at initial time points |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Factors Influencing Knowledge & Attitude
Vaccine uptake
|
at baseline |
|
|
Target Sample Size
|
Total Sample Size="1778"
Sample Size from India="1778"
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) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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 - NO
|
|
Brief Summary
|
Title- Knowledge and Attitude about Human Papillomavirus Vaccination among men in Mulki Taluk : A cross- sectional study Objectives- To determine the knowledge and attitude about Human Papillomavirus Vaccination among men in Mulki Taluk Methodology Study design
This study is a community based Cross sectional study
Study setting
The study will be conducted in Mulki Taluk which consists of male population of 33275.
Study population
Men between the age group of 19 - 45 years
Inclusion criteria
Men residing in Mulki since 1 year between the age group 19 - 45years
Exclusion criteria
Men who are not able to comprehend the questions within the age 19 – 45 years Outcome The study will provide insights about knowledge and attitude about Human Papillomavirus vaccination among men in Mulki taluk and help design targeted interventions to improve vaccination policies.
|