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Human Papilloma Virus-Related CarcinomaNCT00863096

Human Papillomavirus Screening and Vaccine Readiness Program

An observational study of Human Papilloma Virus-Related Carcinoma, run by Public Health Research Institute, India at 1 site in India.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Human Papilloma Virus-Related Carcinoma
What is being tested?
Gardasil
Type of treatment
Vaccines
How many people
450 participants
Where
1 siteIndia
Study dates
Jun 2009to Dec 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Young women who participated in the formative study on acceptability of HPV vaccine in Mysore, India

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

India1 site
  • Public Health Research Institute, India

    Mysore, Karnataka, 560021

Other trials in India

About this study

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.

Read the 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..

Being tested
Gardasil
Keywords
HPV, acceptability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GardasilBiological

    Also called HPV vaccine

    HPV vaccine

Study groups in NCT00863096
Study groupRoleWhat they receive
GardasilNot described
Receives: Biological: Gardasil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability of HPV vaccine

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionJun 2010
  4. Study completionDec 2010 (estimated)

Why it stopped: Unable to get the vaccine on time to offer it to the study population.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00863096
Sponsor's protocol ID
GAT.1246-04-07527-GRT
Status last verified
Mar 2009
First submitted
16 Mar 2009
Last updated
3 Mar 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Human Papilloma Virus-Related Carcinoma, run by Public Health Research Institute, India at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of HPV vaccine (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2011.

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