Human Papillomavirus Screening and Vaccine Readiness Program

Human Papilloma Virus-Related Carcinoma Clinical Trial

Official title:

Human Papillomavirus Screening and Vaccine Readiness Program

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00863096
• Other study ID #: GAT.1246-04-07527-GRT
• Status: Withdrawn
• Phase: N/A
• First received: March 16, 2009
• Last updated: March 2, 2011
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2009
• Source: Public Health Research Institute, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 450
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Human Papilloma Virus-Related Carcinoma

Intervention

Biological:
• Gardasil
HPV vaccine

Locations

Country	Name	City	State
India	Public Health Research Institute, India	Mysore	Karnataka

Sponsors (2)

Lead Sponsor	Collaborator
Public Health Research Institute, India	PATH

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of HPV vaccine		One year	No