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Acceptability and Feasibility of Human Papilloma Virus Vaccine

Acceptability and Feasibility of Human Papilloma Virus Vaccine

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01209338
Enrollment
1000
Registered
2010-09-27
Start date
2009-11-30
Completion date
2010-12-31
Last updated
2010-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

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.

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.

Interventions

BEHAVIORALHealth education

Health education about HPV infection, HPV vaccine and cervix cancer.

Sponsors

Tata Memorial Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
To determine the Knowledge, Attitude and Practice about cervix cancer, Human Papilloma Virus (HPV).8 months1. 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

MeasureTime frameDescription
. To identify the barriers and facilitators perceived by women for vaccinating their daughters against HPV infection and cervix cancer.8 monthsTo determine barriers and facilitators for vaccine acceptability between sensitized and non- sensitized group.

Countries

India

Contacts

Primary ContactSharmila A Pimple, MD
drsharmilapatil@yahoo.com+91-22-24154379
Backup ContactGauravi A Mishra, MD
gauravi2005@yahoo.co.in+91-22-24157532

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026