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

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.


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:


Communicable Diseases Infection Papillomavirus Infections	DNA Virus Infections Tumor Virus Infections Virus Diseases

ClinicalTrials.gov processed this record on March 01, 2015

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