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Recruitment Status : Withdrawn (Unable to get the vaccine on time to offer it to the study population.)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
|Condition or disease||Intervention/treatment|
|Human Papilloma Virus-Related Carcinoma||Biological: Gardasil|
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..
|Study Type :||Observational|
|Estimated Enrollment :||450 participants|
|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|
Other Name: HPV vaccine
- Acceptability of HPV vaccine [ Time Frame: One year ]
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
|Public Health Research Institute, India|
|Mysore, Karnataka, India, 560021|
|Principal Investigator:||Purnima Madhivanan Madhivanan, MD, PhD||Public Health Research Institute, India|