Acceptability and Feasibility of Human Papilloma Virus Vaccine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Tata Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01209338
First received: June 16, 2010
Last updated: September 27, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Cervical Cancer
Behavioral: Health education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Acceptability and Feasibility of Human Papilloma Virus Vaccine

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • To determine the Knowledge, Attitude and Practice about cervix cancer, Human Papilloma Virus (HPV). [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • . To identify the barriers and facilitators perceived by women for vaccinating their daughters against HPV infection and cervix cancer. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    To determine barriers and facilitators for vaccine acceptability between sensitized and non- sensitized group.


Estimated Enrollment: 1000
Study Start Date: November 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: Health education
Health education about HPV infection, HPV vaccine and cervix cancer.
No Intervention: 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.
Behavioral: Health education
Health education about HPV infection, HPV vaccine and cervix cancer.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209338

Contacts
Contact: Sharmila A Pimple, MD +91-22-24154379 drsharmilapatil@yahoo.com
Contact: Gauravi A Mishra, MD +91-22-24157532 gauravi2005@yahoo.co.in

Locations
India
Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Sharmila A Pimple, MD    +91-22-24154379    drsharmilapatil@yahoo.com   
Contact: Gauravi A Mishra, MD    +91-22-24157532    gauravi2005@yahoo.co.in   
Principal Investigator: Sharmila A Pimple         
Principal Investigator: Gauravi A Mishra         
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Sharmila A Pimple, MD Tata Memorial Hospital
Principal Investigator: Gauravi A Mishra, MD Tata Memorial Hospital
  More Information

No publications provided

Responsible Party: Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT01209338     History of Changes
Other Study ID Numbers: 655
Study First Received: June 16, 2010
Last Updated: September 27, 2010
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 22, 2014