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

February 2, 2011
November 15, 2013
February 2011
August 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01295242 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Natural History of Human Papillomavirus (HPV) Infections in Mid-Adult Women (WHIM)
Natural History of HPV Infections in Mid-Adult Women

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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

Papillomavirus Infections
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
409
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Female
30 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01295242
39810-C
No
Rachel Winer, University of Washington
University of Washington
Not Provided
Principal Investigator: Rachel L Winer, PhD, MPH University of Washington
University of Washington
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP