| CTRI Number |
CTRI/2024/02/063161 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [HEALTH EDUCATION INTERVENTION] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Human Papilloma Virus vaccine health education on knowledge, attitude and practice among school going students of two schools in Manipur: A Non-Randomized Control Trial |
|
Scientific Title of Study
|
Effectiveness of Human Papilloma Virus vaccine health education on knowledge, attitude and practice among school going students of two schools in Manipur: A Non-Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Dhali |
| Designation |
Post Graduate Trainee, Department of Community Medicine |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Community Medicine ,Regional Institute of Medical sciences, Lamphelpat,Imphal,Manipur
Room-219,1st Floor, Kundolei Ladies PG Hostel,Regional Institute Of Medical Sciences, Lamphelpat,Imphal,Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9836933422 |
| Fax |
|
| Email |
dr.sdhali.96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. H. Sanayaima Devi |
| Designation |
Professor and Head of the Department, Department of Community Medicine |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department Of Community Medicine, Regional Institute of Medical Sciences, Lamphelpat, Imphal West, Manipur
Wangkhei Lourembam Leikai,
Near Durga Puja Lampak,
Imphal East-795005
Imphal East
MANIPUR
795004
India |
| Phone |
8575016616 |
| Fax |
|
| Email |
drsnanahj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sneha Dhali |
| Designation |
Post Graduate Trainee, Department of Community Medicine |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Community Medicine, Regional Institute of Medical Sciences, Lamphelpat, Imphal
ROOM-219,1ST FLOOR, KUNDOLEI LADIES PG HOSTEL,REGIONAL INSTITUTE OF MEDICAL SCIENCES, LAMPHELPAT,IMPHAL,MANIPUR
Imphal West
MANIPUR
795004
India |
| Phone |
9836933422 |
| Fax |
|
| Email |
dr.sdhali.96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sneha Dhali (Principal Investigator),Department of Community Medicine, Regional Institute of Medical sciences, Lamphelpat, Imphal, Manipur |
|
|
Primary Sponsor
|
| Name |
Sneha Dhali |
| Address |
Department of Community Medicine, Regional Institute of Medical Sciences, Imphal, Manipur |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sneha Dhali |
Two Schools |
Imphal West
Imphal West
MANIPUR |
09836933422
dr.sdhali.96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health Education |
Various domains about the HPV virus, its effects on human body, HPV vaccine and its benefits and other related topics will be covered under the different sessions and will be divided and covered |
| Comparator Agent |
No Intervention |
No intervention will be provided |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Students belonging to grade VII, VIII and IX |
|
| ExclusionCriteria |
| Details |
Students who were not present on the first day of data collection. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge, attitude and practice regarding the HPV vaccination |
Baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="372"
Sample Size from India="372"
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)
|
07/03/2024 |
| 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="2"
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
|
Prior to study
initiation and after obtaining ethical approval, a written permission will be
sought from the principals of both schools to conduct the study. Verbal assent
will be obtained from the students. The purpose and the procedure of the study
will be then explained to the study participants thoroughly. Participants will
be administered an envelope which will
contain a questionnaire which they will be asked to fill in completely. The
medical students will be reassured about their anonymity at the time of
questionnaire administration. No name will be collected during this entire
procedure. After obtaining the consent, the students will be asked to sit in an
ordered manner of atleast one hand distance and asked to fill in the
questionnaire and time allotment will be 30 mins , during which thorough invigilation will be done so as to
avoid any sort of discussion between them. Students will be briefed about the importance
of honest answer and not to copy from each other. The invigilator will remain
present throughout the study period in the class. If any doubts arise, they
will be clarified at the end of the follow-up period.
After
completion of all the 4 sets of the questionnaire form, Intervention will be
given just after in the form of health education which will include lecture cum
group discussion and the second session
of the intervention will be done after a
period of 1 week which would include audio visual aids,video shows, pamphlet
distribution and a quiz program. The study participants for the intervention
group and the control group will be requested to gather again after 3 months
for follow-up. The same questionnaire that is used for pre-test will be
administered again after 3 months for post-test. Purposive sampling
method will be used in this study. Details of the schools will be taken from
the Directorate of Education, Manipur. Out of the eligible schools, 2 schools
will be selected purposively. One school will be allocated in the intervention
group, and one school will be allocated to the control group. From each of the
selected school, 62 students will be selected from each standard (VII, VIII,
IX) using simple random sampling from the attendance registers to acquire total
sample size of 372 (186 from each school). |