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.
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.
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..
- Conditions
- Human Papilloma Virus-Related Carcinoma
- 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 group | Role | What they receive |
|---|---|---|
| Gardasil | Not described Receives: Biological: Gardasil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted17 Mar 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionDec 2010 (estimated)
Why it stopped: Unable to get the vaccine on time to offer it to the study population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma Virus-Related CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Public Health Research Institute, India
- Sponsor type
- University, hospital or other
- Collaborators
- PATH
- Investigators
- Purnima Madhivanan Madhivanan, MD, PhD, Principal investigator, Public Health Research Institute, India
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomavirus Screening and Vaccine Readiness Program
- ClinicalTrials.gov ID
- NCT00863096
- Acronym / sponsor ID
- GAT.1246-04-07527-GRT
- Conditions
- Human Papilloma Virus-Related Carcinoma
- Keywords
- HPV, acceptability
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to get the vaccine on time to offer it to the study population.
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Public Health Research Institute, IndiaUniversity, hospital or other
- Collaborators
- PATH
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (estimated)
- First posted
- 17 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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..
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gardasil | – | Biological: Gardasil |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young women who participated in the formative study on acceptability of HPV vaccine in Mysore, India
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GardasilAlso: HPV vaccineHPV vaccine | Biological | Gardasil |
Primary outcome
Acceptability of HPV vaccine
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Purnima Madhivanan Madhivanan, MD, PhD principal investigator
Public Health Research Institute, India
1 site in 1 country: see every site and its status.
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.