High-Risk HPV Infections in Women Aged 25 to 65

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rachel Winer, University of Washington
ClinicalTrials.gov Identifier:
NCT00461877
First received: April 16, 2007
Last updated: November 15, 2013
Last verified: November 2013

April 16, 2007
November 15, 2013
March 2007
December 2008   (final data collection date for primary outcome measure)
High-Risk HPV DNA [ Time Frame: four months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00461877 on ClinicalTrials.gov Archive Site
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High-Risk HPV Infections in Women Aged 25 to 65
High-Risk HPV Infections in Women Aged 25 to 65

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.

Whether older women are susceptible to acquiring new, persistent high-risk (HR) HPV infections from new sex partners is largely unknown. This is a pilot 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. 400 women will be recruited and mailed kits for self-collecting vaginal specimens for HPV DNA testing. Women will self-collect two sets of vaginal specimens four months apart, and complete sexual behavior questionnaires at the time of each self-collection. If new HPV infections associated with recent new partners are detected in these women, this pilot data will be used to develop a larger longitudinal study of the acquisition and natural history of HR HPV infections in older women. This information is important for developing guidelines for HPV vaccine implementation and cervical cancer screening guidelines in populations of older women.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Vaginal swab samples for HPV DNA testing

Non-Probability Sample

25 to 65 year old women who date online

Papillomavirus Infections
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
303
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Pregnant, breastfeeding, or planning a pregnancy in the next 6 months
  • Hysterectomy
Female
25 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00461877
31286
No
Rachel Winer, University of Washington
University of Washington
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Rachel L Winer, PhD University of Washington
University of Washington
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP