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

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.

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Key information

Conditions

Papillomavirus Infections Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Infections Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

30 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Presence of type-specific HPV DNA in self-collected oral and vaginal swab samples

Time frame: once a month for 6 months

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Natural History of HPV Infections in Mid-Adult Women

Acronym: WHIM

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Feb 14, 2011
Registry last updated: Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed