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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Washington.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01295242
First received: February 2, 2011
Last updated: March 25, 2011
Last verified: March 2011
History of Changes
  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.


Estimated Enrollment: 500
Study Start Date: February 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: February 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295242

Contacts
Contact: Sandra O'Reilly, BS 206-543-3327 hhhstudy@uw.edu
Contact: Lauren Asaba, ARNP 206-543-3327 hhhstudy@uw.edu

Locations
United States, Washington
University of Washington Recruiting
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 L. 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: March 25, 2011
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 June 18, 2013