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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rachel Winer, University of Washington
ClinicalTrials.gov Identifier:
NCT01295242
First received: February 2, 2011
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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.


Condition
Papillomavirus Infections

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

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.

  Eligibility

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)

Criteria

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
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: NCT01295242

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

No publications provided

Responsible Party: Rachel Winer, Assistant Professor, University of Washington
ClinicalTrials.gov 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:
HPV
Cervical Cancer

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

ClinicalTrials.gov processed this record on July 24, 2014