Prevalence, Persistence, and Risk Factors for Oral Human Papillomavirus (HPV) Infections in College Women (HOP-IN)
This study has been completed.
Sponsor:
University of Florida
Collaborator:
Merck
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01289873
First received: February 2, 2011
Last updated: February 7, 2013
Last verified: February 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 2, 2011 | ||||
| Last Updated Date | February 7, 2013 | ||||
| Start Date ICMJE | May 2011 | ||||
| Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Prevalence of oral HPV [ Time Frame: at enrollment ] [ Designated as safety issue: No ] any oral HPV at enrollment |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01289873 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Persistence of oral HPV over 1 year of follow-up [ Time Frame: 1 year ] [ Designated as safety issue: No ] Determine whether HPV remains present at 3-months, 6-months, and 12-months after enrollment |
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| 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 | Prevalence, Persistence, and Risk Factors for Oral Human Papillomavirus (HPV) Infections in College Women | ||||
| Official Title ICMJE | Prevalence, Persistence, and Risk Factors for Oral HPV Infections in College Women | ||||
| Brief Summary | The purpose of this study is to determine how common oral HPV infections are in college women. The investigators also will find out what risk factors are associated with having oral HPV infections. The investigators hypothesize that approximately 3% of women will have oral HPV, and that HPV will be associated with oral sexual behaviors and with smoking behaviors. Finally, for those women with oral HPV- the investigators will determine whether the infections are persistent (still present) at 3-, 6-, and 12-months after the initial diagnosis. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | female college students |
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| Condition ICMJE | Human Papillomavirus | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 1035 | ||||
| Completion Date | September 2012 | ||||
| Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| 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 | NCT01289873 | ||||
| Other Study ID Numbers ICMJE | Merck IISP 37942 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Florida | ||||
| Study Sponsor ICMJE | University of Florida | ||||
| Collaborators ICMJE | Merck | ||||
| Investigators ICMJE |
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| Information Provided By | University of Florida | ||||
| Verification Date | February 2013 | ||||
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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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