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Natural History of HPV Infections in Mid-Adult Women


N/A
30 Years
50 Years
Open (Enrolling)
Female
Papillomavirus Infections

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Trial Information

Natural History of HPV Infections in Mid-Adult Women


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.


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

Exclusion Criteria:

- pregnant

- have had hysterectomy

- serious medical condition which prevents completion of activities of daily living

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Presence of type-specific HPV DNA in self-collected oral and vaginal swab samples

Outcome Time Frame:

once a month for 6 months

Safety Issue:

No

Principal Investigator

Rachel L Winer, PhD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington

Authority:

United States: Institutional Review Board

Study ID:

39810-C

NCT ID:

NCT01295242

Start Date:

February 2011

Completion Date:

December 2012

Related Keywords:

  • Papillomavirus Infections
  • HPV
  • Cervical Cancer
  • Papillomavirus Infections

Name

Location

University of Washington Seattle, Washington  98195