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Trial Title:
Acceptability and Feasibility of Human Papilloma Virus Vaccine
NCT ID:
NCT01209338
Condition:
Cervical Cancer
Conditions: Official terms:
Papilloma
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Health education
Description:
Health education about HPV infection, HPV vaccine and cervix cancer.
Arm group label:
non-sensitized group
Arm group label:
sensitized group
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.
Detailed description:
The eligible participant will be chosen by door-door household visit. Each participant
will be given information regarding the study and written informed consent will be
obtained from them. Their participation will be entirely voluntary and no pressure or
coercion will be used. Our team will help them with questions that are not well
understood by them or are ambiguous for them. The questionnaire is in 2 sections. Section
one will try and ascertain the mother's Knowledge, Attitude and Perception regarding
cervix cancer, HPV infection and HPV Vaccination.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
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.
Exclusion Criteria:
Women with no children or with daughters outside the 10-18 yrs age group have been
excluded.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Tata Memorial Hospital
Address:
City:
Mumbai
Zip:
400012
Country:
India
Status:
Recruiting
Contact:
Last name:
Sharmila A Pimple, MD
Phone:
+91-22-24154379
Email:
drsharmilapatil@yahoo.com
Contact backup:
Last name:
Gauravi A Mishra, MD
Phone:
+91-22-24157532
Email:
gauravi2005@yahoo.co.in
Investigator:
Last name:
Sharmila A Pimple
Email:
Principal Investigator
Investigator:
Last name:
Gauravi A Mishra
Email:
Principal Investigator
Start date:
November 2009
Completion date:
December 2010
Lead sponsor:
Agency:
Tata Memorial Hospital
Agency class:
Other
Source:
Tata Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01209338
