Acceptability and Feasibility of Human Papilloma Virus Vaccine
1 other identifier
interventional
1,000
1 country
1
Brief Summary
The overall program goal is to determine the Acceptability and Feasibility of introducing a population based Human Papilloma Virus (HPV) Vaccination programme and understanding the key individual and community factors that would determine the potential acceptability of the vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 16, 2010
CompletedFirst Posted
Study publicly available on registry
September 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedSeptember 28, 2010
September 1, 2010
1.1 years
June 16, 2010
September 27, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the Knowledge, Attitude and Practice about cervix cancer, Human Papilloma Virus (HPV).
1. To determine the Knowledge, Attitude and Practice about cervix cancer, Human Papilloma Virus (HPV) and HPV Vaccines amongst the target population. 2. To promote awareness regarding cervix cancer and its screening amongst the community. 3. To assess the feasibility and logistics of various strategies for reaching girls with HPV Vaccines.
8 months
Secondary Outcomes (1)
. To identify the barriers and facilitators perceived by women for vaccinating their daughters against HPV infection and cervix cancer.
8 months
Study Arms (2)
sensitized group
ACTIVE COMPARATOROne arm will be a sensitized group which would have received cancer health awareness sessions and / or screening earlier at least once in the past.
non-sensitized group
NO INTERVENTIONThe 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.
Interventions
Health education about HPV infection, HPV vaccine and cervix cancer.
Eligibility Criteria
You may qualify if:
- All married women bearing daughters of the age group 10-18 years and are conversant in either Marathi, Hindi or English will be included in the study.
You may not qualify if:
- Women with no children or with daughters outside the 10-18 yrs age group have been excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tata Memorial Hospital
Mumbai, Maharashtra, 400012, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharmila A Pimple, MD
Tata Memorial Hospital
- PRINCIPAL INVESTIGATOR
Gauravi A Mishra, MD
Tata Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
June 16, 2010
First Posted
September 27, 2010
Study Start
November 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
September 28, 2010
Record last verified: 2010-09