Acceptability and Feasibility of Human Papilloma Virus Vaccine
NCT ID: NCT01209338
Last Updated: 2010-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1000 participants
INTERVENTIONAL
2009-11-30
2010-12-31
Brief Summary
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Detailed Description
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Section 1 will be interviewed for a period of 5-10 minutes followed by an information sheet providing details on HPV infection, its association with cervix cancer and HPV Vaccination against cervix cancer. The information sheet available will be explained to them for a period of 10-15 minutes. Our social workers will be available at all times to allay their misinterpretations. This will be followed by section 2 which will be a post intervention questionnaire comprising of questions regarding their attitude towards HPV vaccination and identifying barriers and motivators for these women towards vaccination.
The post-intervention questionnaire would be interviewed for a period of 10-15 minutes, thus a total of 25-40 minutes will be made available to every participant for the entire session. The team is expected to cover 15 women per day totaling to 300 women per month considering the monthly holidays and time lost in certain administrative issues.
Patients will be recruited for 4 months which will be followed by data entry, data analysis, formulation of results and write -up. Thus the entire study will last for eight months. The questionnaire consists of mostly close ended questions with options in the form of yes/no/do not know. Some questions which require definitive answers have been provided with plausible options. Some questions have been left open ended so as to avoid ambiguity. The questionnaire is simple, in continuity and is translated into Hindi and Marathi languages so as to meet the needs of the local population.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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sensitized group
One arm will be a sensitized group which would have received cancer health awareness sessions and / or screening earlier at least once in the past.
Health education
Health education about HPV infection, HPV vaccine and cervix cancer.
non-sensitized group
The second arm will belong to an area which has never been exposed to any form of cancer awareness or screening activities thus this group is a completely non-sensitized group.
Health education
Health education about HPV infection, HPV vaccine and cervix cancer.
Interventions
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Health education
Health education about HPV infection, HPV vaccine and cervix cancer.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Tata Memorial Hospital
OTHER_GOV
Responsible Party
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Tata Memorial Hospital
Principal Investigators
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Sharmila A Pimple, MD
Role: PRINCIPAL_INVESTIGATOR
Tata Memorial Hospital
Gauravi A Mishra, MD
Role: PRINCIPAL_INVESTIGATOR
Tata Memorial Hospital
Locations
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Tata Memorial Hospital
Mumbai, Maharashtra, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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655
Identifier Type: -
Identifier Source: org_study_id