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Human Papillomavirus Screening and Vaccine Readiness Program

18 Years
45 Years
Not Enrolling
Human Papilloma Virus-Related Carcinoma

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Trial Information

Human Papillomavirus Screening and Vaccine Readiness Program

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

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

Inclusion 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Acceptability of HPV vaccine

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Purnima Madhivanan Madhivanan, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Public Health Research Institute, India


India: Institutional Review Board

Study ID:




Start Date:

June 2009

Completion Date:

December 2010

Related Keywords:

  • Human Papilloma Virus-Related Carcinoma
  • HPV
  • acceptability
  • Carcinoma
  • Papilloma