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

Papillomavirus Infections Clinical Trial

— WHIM  

Official title:

Natural History of HPV Infections in Mid-Adult Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295242
• Other study ID #: 39810-C
• Status: Completed
• Phase: N/A
• First received: February 2, 2011
• Last updated: November 15, 2013
• Start date: February 2011
• Est. completion date: August 2012

Study information

• Verified date: November 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Papillomavirus Infections

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of type-specific HPV DNA in self-collected oral and vaginal swab samples		once a month for 6 months	No