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Acceptability and Feasibility of Human Papilloma Virus Vaccine

18 Years
Open (Enrolling)
Cervical Cancer

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Trial Information

Acceptability and Feasibility of Human Papilloma Virus Vaccine

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

To determine the Knowledge, Attitude and Practice about cervix cancer, Human Papilloma Virus (HPV).

Outcome Description:

To determine the Knowledge, Attitude and Practice about cervix cancer, Human Papilloma Virus (HPV) and HPV Vaccines amongst the target population. To promote awareness regarding cervix cancer and its screening amongst the community. To assess the feasibility and logistics of various strategies for reaching girls with HPV Vaccines.

Outcome Time Frame:

8 months

Safety Issue:


Principal Investigator

Sharmila A Pimple, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tata Memorial Hospital


India: Institutional Review Board

Study ID:




Start Date:

November 2009

Completion Date:

December 2010

Related Keywords:

  • Cervical Cancer
  • Uterine Cervical Neoplasms
  • Papilloma