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HPV Infections in Older Women

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ClinicalTrials.gov Identifier: NCT00743392
Recruitment Status : Completed
First Posted : August 28, 2008
Last Update Posted : November 19, 2013
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Papillomavirus Infections

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

Study Type : Observational
Actual Enrollment : 503 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HPV Infections in Older Women
Study Start Date : July 2008
Primary Completion Date : May 2011
Study Completion Date : May 2011
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. High-risk HPV DNA [ Time Frame: Every 4 months for 1 year ]

Biospecimen Retention:   Samples With DNA
Vaginal swab samples for HPV DNA testing

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
25 to 65 year old women who date online

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743392

United States, Washington
University of Washington
Seattle, Washington, United States, 98103
Sponsors and Collaborators
University of Washington
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Rachel L Winer, PhD University of Washington
More Information

Additional Information:
Responsible Party: Rachel Winer, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00743392     History of Changes
Other Study ID Numbers: 34339-A
First Posted: August 28, 2008    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Communicable Diseases
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections