Papillomavirus InfectionsNCT00743392
HPV Infections in Older Women
An observational study of Papillomavirus Infections, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to determine risk factors for HPV infections in 25 to 65 year old women who report having used internet dating websites in the past year. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections
- How many people
- 503 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to May 2011
- 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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 25 to 65 year old women who date online
Who may be able to join
- Have had sex with men
- Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website)
Who cannot join
- Pregnant, breastfeeding, or planning a pregnancy in the next 6 months
- Hysterectomy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine risk factors for HPV infections in 25 to 65 year old women who report having used internet dating websites in the past year.
Read the detailed description
Whether older women are susceptible to acquiring new, persistent high-risk (HR) HPV infections from new sex partners is largely unknown. This is a longitudinal study of predictors of HR HPV infections in two populations of women aged 25 to 44 and 45 to 65 who have used internet dating websites in the past year. 300 women will be recruited and mailed kits for self-collecting vaginal specimens for HPV DNA testing. Women will self-collect four sets of vaginal specimens four months apart, and complete sexual behavior questionnaires at the time of each self-collection. We will identify behavioral and health predictors of type-specific HR HPV infections, predictors of repeatedly-detected HR HPV infections, and evaluate study participants' experiences with self-collecting vaginal specimens and attitudes towards HPV vaccination and cervical cancer screening. This information is important for developing guidelines for HPV vaccine implementation and cervical cancer screening guidelines in populations of older women.
- Conditions
- Papillomavirus Infections
- Medical subject headings
- Papillomavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
High-risk HPV DNA
Measured: Every 4 months for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Winer, University of Washington
- Investigators
- Rachel L Winer, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743392
- Sponsor's protocol ID
- 34339-A
- Status last verified
- Nov 2013
- First submitted
- 26 Aug 2008
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Infections in Older Women
- ClinicalTrials.gov ID
- NCT00743392
- Acronym / sponsor ID
- 34339-A
- Conditions
- Papillomavirus Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jul 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 28 Aug 2008 (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.
The purpose of this study is to determine risk factors for HPV infections in 25 to 65 year old women who report having used internet dating websites in the past year.
Detailed description
Whether older women are susceptible to acquiring new, persistent high-risk (HR) HPV infections from new sex partners is largely unknown. This is a longitudinal study of predictors of HR HPV infections in two populations of women aged 25 to 44 and 45 to 65 who have used internet dating websites in the past year. 300 women will be recruited and mailed kits for self-collecting vaginal specimens for HPV DNA testing. Women will self-collect four sets of vaginal specimens four months apart, and complete sexual behavior questionnaires at the time of each self-collection. We will identify behavioral and health predictors of type-specific HR HPV infections, predictors of repeatedly-detected HR HPV infections, and evaluate study participants' experiences with self-collecting vaginal specimens and attitudes towards HPV vaccination and cervical cancer screening. This information is important for developing guidelines for HPV vaccine implementation and cervical cancer screening guidelines in populations of older women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 25 to 65 year old women who date online
Key inclusion criteria (2 listed)
- Have had sex with men
- Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website)
Key exclusion criteria (2 listed)
- Pregnant, breastfeeding, or planning a pregnancy in the next 6 months
- Hysterectomy
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
High-risk HPV DNA
Time frame: Every 4 months for 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
- HPV study websiteLink provided by the sponsor.
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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.
Rachel L Winer, PhD principal investigator
University of Washington
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 Papillomavirus Infections, run by University of Washington at 1 site in United States.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 19 Nov 2013. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
High-risk HPV DNA (time frame: Every 4 months for 1 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 19 Nov 2013.