HPV Infections in Older Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rachel Winer, University of Washington
ClinicalTrials.gov Identifier:
NCT00743392
First received: August 26, 2008
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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
Papillomavirus Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: HPV Infections in Older Women

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • High-risk HPV DNA [ Time Frame: Every 4 months for 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Vaginal swab samples for HPV DNA testing


Enrollment: 503
Study Start Date: July 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

25 to 65 year old women who date online

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743392

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98103
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Rachel L Winer, PhD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: Rachel Winer, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00743392     History of Changes
Other Study ID Numbers: 34339-A
Study First Received: August 26, 2008
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014