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Human Papillomavirus Screening and Vaccine Readiness Program

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ClinicalTrials.gov Identifier: NCT00863096
Recruitment Status : Withdrawn (Unable to get the vaccine on time to offer it to the study population.)
First Posted : March 17, 2009
Last Update Posted : March 3, 2011
Sponsor:
Collaborator:
PATH
Information provided by:
Public Health Research Institute, India

Brief Summary:
Public Health Research Institute (PHRI) is carrying out a 15 month research and advocacy project with the goals of generating critical data on acceptability, identifying determinants and facilitators of HPV vaccine uptake in adolescent girls; and investigating physicians' attitudes to identify predictors of intention to recommend immunization in Mysore, India.

Condition or disease Intervention/treatment
Human Papilloma Virus-Related Carcinoma Biological: Gardasil

Detailed Description:

Discovery of the viral etiology of cervical cancer has opened up the possibility of primary prevention through vaccination. High-risk sexually transmitted types of human papillomavirus (HPV) have been identified as a necessary agent in cervical carcinogenesis, and work on vaccine development has progressed rapidly. Vaccines for HPV types 16 and 18, which are implicated in ~70% of cervical cancers, as well as types 6 and 11, which cause genital warts, have been shown to be effective and have been licensed in the last year. Modeling studies have indicated that an HPV vaccine could be cost-effective even alongside existing screening programs. Ideally, girls should be vaccinated before the onset of sexual activity, and estimates suggest that introduction of an HPV vaccination at age 12 could reduce lifetime cervical cancer incidence by up to 94%. As with any new technology, the success of HPV vaccination will be dependent on levels of acceptability and uptake. Given the need for parental consent in India, research into parental acceptance is of vital importance.

Although parental acceptance of vaccination against sexually transmitted infections (STI) including HPV, appears high in other parts of the world, there is little data in India. In previous research from other parts of the world, the biggest concern identified was that vaccinations may disinhibit risky sexual activity among adolescents. Other attitudes and beliefs that may influence parental uptake of an HPV vaccine include fear of potential side effects, concern about giving children too many vaccinations, the belief that vaccinations may cause disease, and religious and cultural taboos against vaccination. There is a critical need to develop data and experience that will provide the information needed by policymakers prior to the introduction of a cervical cancer vaccine in India.

The present research will be guided by the ecological framework and identify where the locus of HPV vaccine decision-making lies in an Indian setting. This project will explore household, peer and authority figure influencers in vaccine uptake. This process will include qualitative research methods such as focus group discussions and one-on-one interviews..

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Human Papillomavirus Screening and Vaccine Readiness Program
Study Start Date : June 2009
Actual Primary Completion Date : June 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Gardasil Biological: Gardasil
HPV vaccine
Other Name: HPV vaccine




Primary Outcome Measures :
  1. Acceptability of HPV vaccine [ Time Frame: One year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Young women who participated in the formative study on acceptability of HPV vaccine in Mysore, India
Criteria

Inclusion Criteria

  • Potential participants must have at least one daughter between 8 and 14 years of age
  • Be a decision maker for the welfare of a girl aged 8-14 years
  • Be able to understand and give informed consent
  • Be able to speak Kannada

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863096


Locations
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India
Public Health Research Institute, India
Mysore, Karnataka, India, 560021
Sponsors and Collaborators
Public Health Research Institute, India
PATH
Investigators
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Principal Investigator: Purnima Madhivanan Madhivanan, MD, PhD Public Health Research Institute, India
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Responsible Party: Purnima Madhivanan, Public Health Research Institute
ClinicalTrials.gov Identifier: NCT00863096    
Other Study ID Numbers: GAT.1246-04-07527-GRT
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: March 3, 2011
Last Verified: March 2009
Keywords provided by Public Health Research Institute, India:
HPV
acceptability
Additional relevant MeSH terms:
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Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs