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Natural History of Human Papillomavirus (HPV) Infections in Mid-Adult Women (WHIM)

Completed
Conditions
Papillomavirus Infections
Registration Number
NCT01295242
Lead Sponsor
University of Washington
Brief Summary

The purpose of this study is to determine rates of oral and genital human papillomavirus (HPV) infections, and look at risk factors for HPV infection in healthy mid-adult women.

Detailed Description

The investigators propose a longitudinal study of 500 women in order to determine rates and risk factors for HPV infections in 30-50 year old women. Participants will be followed for 6 months and will be asked to complete online questionnaires on their health, sexual behavior, HPV vaccinations, and cervical cancer screening. The investigators will ask participants to self-collect monthly vaginal swab samples and self-collect 2 oral swab samples. Women will also be asked to provide 2 blood samples. All swab samples will be tested for type-specific HPV deoxyribonucleic acid (DNA) using a polymerase chain reaction (PCR)-based assay, blood samples will be tested for HPV antibodies.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
409
Inclusion Criteria
  • affiliated with the University of Washington (student, staff, faculty)
  • willing to self-collect vaginal samples at home for HPV testing
  • able to provide informed consent
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Exclusion Criteria
  • pregnant
  • have had hysterectomy
  • serious medical condition which prevents completion of activities of daily living
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Presence of type-specific HPV DNA in self-collected oral and vaginal swab samplesonce a month for 6 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Washington

🇺🇸

Seattle, Washington, United States

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