High-Risk HPV Infections in Women Aged 25 to 65
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | April 16, 2007 | ||||
| Last Updated Date | August 25, 2008 | ||||
| Start Date ICMJE | March 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
High-Risk HPV DNA [ Time Frame: four months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00461877 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | High-Risk HPV Infections in Women Aged 25 to 65 | ||||
| Official Title ICMJE | High-Risk HPV Infections in Women Aged 25 to 65 | ||||
| Brief Summary | The purpose of this study is to determine risk factors for HPV infections in 25 to 65 year old women who report having used internet dating websites in the past year. |
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| Detailed Description | Whether older women are susceptible to acquiring new, persistent high-risk (HR) HPV infections from new sex partners is largely unknown. This is a pilot study of predictors of HR HPV infections in two populations of women aged 25 to 44 and 45 to 65 who have used internet dating websites in the past year. 400 women will be recruited and mailed kits for self-collecting vaginal specimens for HPV DNA testing. Women will self-collect two sets of vaginal specimens four months apart, and complete sexual behavior questionnaires at the time of each self-collection. If new HPV infections associated with recent new partners are detected in these women, this pilot data will be used to develop a larger longitudinal study of the acquisition and natural history of HR HPV infections in older women. This information is important for developing guidelines for HPV vaccine implementation and cervical cancer screening guidelines in populations of older women. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Vaginal swab samples for HPV DNA testing |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | 25 to 65 year old women who date online |
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| Condition ICMJE | Papillomavirus Infections | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 400 | ||||
| Estimated Completion Date | December 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 25 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00461877 | ||||
| Other Study ID Numbers ICMJE | 31286 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Rachel L. Winer/Acting Instructor, University of Washington | ||||
| Study Sponsor ICMJE | University of Washington | ||||
| Collaborators ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Washington | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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