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

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University of Washington

Status

Completed

Conditions

Papillomavirus Infections

Study type

Observational

Funder types

Other

Identifiers

NCT01295242
39810-C

Details and patient eligibility

About

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.

Full 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.

Enrollment

409 patients

Sex

Female

Ages

30 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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