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

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ClinicalTrials.gov Identifier: NCT01295242
Recruitment Status : Completed
First Posted : February 14, 2011
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
Rachel Winer, University of Washington

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Papillomavirus Infections

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.

Study Design
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Study Type : Observational
Actual Enrollment : 409 participants
Time Perspective: Prospective
Official Title: Natural History of HPV Infections in Mid-Adult Women
Study Start Date : February 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Presence of type-specific HPV DNA in self-collected oral and vaginal swab samples [ Time Frame: once a month for 6 months ]

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.

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Rachel Winer, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01295242     History of Changes
Other Study ID Numbers: 39810-C
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by Rachel Winer, University of Washington:
HPV
Cervical Cancer

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