| CTRI Number |
CTRI/2012/12/003269 [Registered on: 28/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
30/08/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to evaluate the awareness and knowledge towards cervical cancer, Human Papillomavirus and HPV vaccines among different healthcare workers. |
|
Scientific Title of Study
|
Awareness and Knowledge about Cervical Cancer, Human Papillomavirus (HPV) and HPV vaccines among Medical personnel. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikrant Chandrakant Sangar |
| Designation |
PhD. Student |
| Affiliation |
B. J. Govt. Medical College, Pune |
| Address |
B. J. Govt. Medical College,
Near Pune Railway Station,
Pune
Pune MAHARASHTRA 411001 India |
| Phone |
9623265391 |
| Fax |
|
| Email |
vikrant_sangar2010@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vikrant Chandrakant Sangar |
| Designation |
PhD. Student |
| Affiliation |
|
| Address |
B. J. Govt. Medical College,
Near Pune Railway Station,
Pune
MAHARASHTRA 411001 India |
| Phone |
9623265391 |
| Fax |
|
| Email |
vikrant_sangar2010@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Vikrant Chandrakant Sangar |
| Designation |
PhD. Student |
| Affiliation |
|
| Address |
B. J. Govt. Medical College,
Near Pune Railway Station,
Pune
MAHARASHTRA 411001 India |
| Phone |
9623265391 |
| Fax |
|
| Email |
vikrant_sangar2010@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Dr B B Ghongane |
B. J. Govt. Medical college and hospital, Pune |
B. J. Govt. Medical College,
Near Pune Railway Station,
Pune-1 Pune MAHARASHTRA |
9922925590
ghongane.phdguide@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| B.J. Medical College& Sassoon General Hospitals ethics_Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention against cancer |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Able to fill the questionnaires used in this study.
2. Able to give a written informed consent.
3. Medical personnel from health care hospitals. |
|
| ExclusionCriteria |
| Details |
1. Participants will be excluded if they are unable to provide written informed consent. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analysis of knowledge and awareness regarding cervical cancer, HPV and HPV vaccines among medical personnel |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Analysis of the use and types of contraceptives to prevent sexual transmitted infections.
2.Analysis of the attitudes towards sex education to their children.
3.Analysis of the attitudes towards HPV vaccines use.
4.Analysis of the willingness of HPV vaccines.
5.Analysis of the utilization of HPV vaccines.
6.Analysis of barriers for HPV vaccination.
7.Analysis of the acceptance of HPV vaccines. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="400" Sample Size from India="400"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/08/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Cervical cancer (CaCx) is one of the leading causes of morbidity and mortality among the gynecological cancer worldwide. In India this cervical cancer is reported to be responsible for almost 20 percent of all female deaths and takes the lives of 8 women in India every hour. India with a population of 365.71 million has women aged between 15 years and above who stand at the risk of developing cervical cancer. India recorded 134420 new cases out of these cases 72825 cases lost their lives. Numerous clinical evidences have established the human papillomavirus (HPV) as a necessary cause of cervical cancer. Knowledge of this association has spurred research on HPV based strategies for cervical cancer prevention, including primary prevention of HPV, HPV vaccines, and the use of HPV testing. In developed countries, a number of preventive strategies are currently being practiced including use of two novel prophylactic vaccines and a number of secondary preventive strategies. Most of these interventions are currently not feasible in low-income countries because of the already limited health care infrastructure. At the same time it is crucial that our health care professionals are aware of the advances and especially of those interventions, which can be utilized, in low-resource settings. It is always important that health care professionals have to play a role in preventing and educating about cervical cancer to patients. In developed countries, similar types awareness studies were carried out and they got positive However to our knowledge no such studies have been conducted within India that explores the current awareness about cervical cancer and HPV vaccines. In this study we aim to access the current knowledge amongst medical personnel staff about cervical cancer and its prevention. Primary Objective: Analysis of knowledge and awareness regarding cervical cancer, HPV and HPV vaccines among medical personnel . Secondary Objective: - Analysis of the use and types of contraceptives to prevent sexual transmitted infections.
- Analysis of the attitudes towards sex education to their children.
- Analysis of the attitudes towards HPV vaccines use.
- Analysis of the willingness of HPV vaccines.
- Analysis of the utilization of HPV vaccines.
- Analysis of barriers for HPV vaccination.
- Analysis of the acceptance of HPV vaccines.
Study Design: A cross-sectional, interview based survey was conducted at B. J. Govt. Medical College (B.J.G.M.C.) and Sassoon General Hospital (S.G.H.), Pune. This B.J.G.M.C. and S.G.H. is one of the largest and busiest government tertiary care hospital and teaching institute in Pune. Sample Size: The target sample size is around 400. Study Procedure: This study aims to assess the knowledge and awareness about cervical cancer and HPV vaccines. The study will involve the following steps – - Subjects will be informed of the objectives and the risks and benefits of the study in local language and will be asked to fill out the questionnaire.
- The option will be provided to enrol and not to enroll, as well as the possibility of withdrawing from the study at any point. After obtaining informed consent, participants will undergo a questionnaire, which is based on the study objectives, taking help from the previous literature and studies available on the topic added with content specific questions. The questionnaire is divided into following parts: 1) includes socio-demographic data of the patient and 2) part consists the questions regarding the knowledge and awareness about epidemiology, etiology, diagnosis and treatment of cervical cancer and 3) part includes questions on HPV vaccines, their use and their opinions on acceptability or implementation in the general population. Single person will do data entry. However twice, two members of the team will enter the same data and the data files will be compared with each other to rule out errors in entering the data. Analysis of data will be carry out by using statistical software.
The target population is medical students, interns, doctors, nurses, technician, pharmacist, medical officer, counselors. They will be selected using convenience sampling. The immediate response was requested for and the questionnaire collected back. |