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

This study has been completed.
Information provided by (Responsible Party):
Rachel Winer, University of Washington Identifier:
First received: February 2, 2011
Last updated: November 15, 2013
Last verified: November 2013

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.

Papillomavirus Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Natural History of HPV Infections in Mid-Adult Women

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Presence of type-specific HPV DNA in self-collected oral and vaginal swab samples [ Time Frame: once a month for 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Self-collected vaginal samples for HPV testing. Self-collected oral samples for HPV testing. Serum samples for HPV antibody testing.

Enrollment: 409
Study Start Date: February 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

30 to 50 year old women affilitated with Univeristy of Washington (student, staff, faculty)


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
  Contacts and Locations
Please refer to this study by its identifier: NCT01295242

United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Principal Investigator: Rachel L Winer, PhD, MPH University of Washington
  More Information

No publications provided

Responsible Party: Rachel Winer, Assistant Professor, University of Washington Identifier: NCT01295242     History of Changes
Other Study ID Numbers: 39810-C
Study First Received: February 2, 2011
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Cervical Cancer

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections processed this record on April 15, 2014