Human PapillomavirusNCT01307774
Survey of Predictors of Human Papillomavirus (HPV) Vaccination Among Parents of Rural Adolescent Girls in Mysore, India
An observational study of Human Papillomavirus and Cervical Cancer, run by Purnima Madhivanan at 2 sites in India.
Trial summary
To conduct a quantitative survey to measure knowledge about Human papillomavirus (HPV) and cervical cancer, and HPV vaccine acceptability among parents of rural adolescent girls in Mysore District, India. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus, Cervical Cancer
- How many people
- 800 participants
- Where
- 2 sitesIndia
- Study dates
- Jun 2014to Dec 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will survey attitudes of parents of adolescent girls attending 10 schools in rural Mysore Taluk in Mysore District.
Who may be able to join
- over 18 years of age
- parent of an adolescent girl (10 -15 years of age)
- able to speak English or Kannada
- willing to undergo informed consent process
Who cannot join
- Does not have the capacity to undergo informed consent process
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Recruiting
Public Health Research Institute of India
Mysore, Karnataka, 560020
Vijaya Srinivas, MD, +8214259555, drvijaya09@gmail.com
- Recruiting
Public Health Research Institute of India
Mysore, Karnataka, 570020
Vijaya Srinivas, MD, +91 821 425 9555, drvijaya09@gmail.com
Purnima Madhivanan, MBBS, PhD, +91 821 425 9555, pmadhivanan2@gmail.com
About this study
Official title: Survey of Predictors of HPV Vaccination Among Parents of Rural Adolescent Girls in Mysore, India
To conduct a quantitative survey to measure knowledge about Human papillomavirus (HPV) and cervical cancer, and HPV vaccine acceptability among parents of rural adolescent girls in Mysore District, India.
Hypothesis: General knowledge and attitudes about the severity and treat ability of cancer will predict acceptability of HPV vaccination among parents of rural adolescent girls in Mysore, India.
- Conditions
- Human Papillomavirus, Cervical Cancer
- Keywords
- parental acceptability of HPV vaccine
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Acceptability of HPV vaccine
Measured: One year
Secondary outcomes (1)
Knowledge about HPV and Cervical Cancer
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 posted3 Mar 2011 (estimated)
- Study startJun 2014
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human PapillomavirusStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purnima Madhivanan
- Sponsor type
- University, hospital or other
- Collaborators
- Florida International University
- Responsible party
- Sponsor-investigator, Purnima Madhivanan, Public Health Research Institute, India
- Investigators
- Purnima Madhivanan, MBBS, PhD, Principal investigator, Public Health Research Institute of India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307774
- Sponsor's protocol ID
- IISP38250
- Status last verified
- Oct 2014
- First submitted
- 2 Mar 2011
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Madhivanan P, Krupp K, Yashodha MN, Marlow L, Klausner JD, Reingold AL. Attitudes toward HPV vaccination among parents of adolescent girls in Mysore, India. Vaccine. 2009 Aug 20;27(38):5203-8. doi: 10.1016/j.vaccine.2009.06.073. Epub 2009 Jul 9.
PubMed 19596420Krupp K, Marlow LA, Kielmann K, Doddaiah N, Mysore S, Reingold AL, Madhivanan P. Factors associated with intention-to-recommend human papillomavirus vaccination among physicians in Mysore, India. J Adolesc Health. 2010 Apr;46(4):379-84. doi: 10.1016/j.jadohealth.2009.10.001. Epub 2009 Nov 24.
PubMed 20307828
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Predictors of HPV Vaccination Among Parents of Rural Adolescent Girls in Mysore, India
- ClinicalTrials.gov ID
- NCT01307774
- Acronym / sponsor ID
- IISP38250
- Conditions
- Human Papillomavirus, Cervical Cancer
- Keywords
- parental acceptability of HPV vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Purnima MadhivananUniversity, hospital or other
- Collaborators
- Florida International University
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 3 Mar 2011 (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.
To conduct a quantitative survey to measure knowledge about Human papillomavirus (HPV) and cervical cancer, and HPV vaccine acceptability among parents of rural adolescent girls in Mysore District, India.
Hypothesis: General knowledge and attitudes about the severity and treat ability of cancer will predict acceptability of HPV vaccination among parents of rural adolescent girls in Mysore, India.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will survey attitudes of parents of adolescent girls attending 10 schools in rural Mysore Taluk in Mysore District.
Key inclusion criteria (4 listed)
- over 18 years of age
- parent of an adolescent girl (10 -15 years of age)
- able to speak English or Kannada
- willing to undergo informed consent process
Key exclusion criteria (1 listed)
- Does not have the capacity to undergo informed consent process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parental Acceptability of HPV vaccine
Time frame: One year
1 secondary outcome
Knowledge about HPV and Cervical Cancer
Time frame: One Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Background: PubMed 19596420Madhivanan P, Krupp K, Yashodha MN, Marlow L, Klausner JD, Reingold AL. Attitudes toward HPV vaccination among parents of adolescent girls in Mysore, India. Vaccine. 2009 Aug 20;27(38):5203-8. doi: 10.1016/j.vaccine.2009.06.073. Epub 2009 Jul 9.
- Background: PubMed 20307828Krupp K, Marlow LA, Kielmann K, Doddaiah N, Mysore S, Reingold AL, Madhivanan P. Factors associated with intention-to-recommend human papillomavirus vaccination among physicians in Mysore, India. J Adolesc Health. 2010 Apr;46(4):379-84. doi: 10.1016/j.jadohealth.2009.10.001. Epub 2009 Nov 24.
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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, MBBS, PhD principal investigator
Public Health Research Institute of India
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus and Cervical Cancer, run by Purnima Madhivanan at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vijaya Srinivas, MD (+91 821 425 9555, drvijaya09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental 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?
On the ClinicalTrials.gov record for NCT01307774, which also lists 2 linked publications.
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 29 Oct 2014.