HPV Infections in Older Women

Papillomavirus Infections Clinical Trial

Official title:

HPV Infections in Older Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743392
• Other study ID #: 34339-A
• Status: Completed
• Phase: N/A
• First received: August 26, 2008
• Last updated: November 15, 2013
• Start date: July 2008
• Est. completion date: May 2011

Study information

• Verified date: November 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Papillomavirus Infections

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High-risk HPV DNA		Every 4 months for 1 year	No

External Links

•   HPV study website