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| ID | Type | Description | Link |
|---|---|---|---|
| USF IRB 104923 |
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This transmission pilot study is a prospective study to determine feasibility of enrolling female partners into an international transmission study. Companion study to MCC-13930.
We planned to enroll 150 female sexual partners, 75 per year for 2 years, of male study participants in the HPV Infection in Men (HIM) Study. The enrollment period is from June 2006 through May 2008 and participants will be followed through May 2010. At all study visits participants will undergo interviews, a physical exam and laboratory analysis for HPV for a total of 5 clinical visits scheduled every 6 months over 2 years of follow-up. In addition, at each study visit, participants will provide blood for HPV antibody analyses. At enrollment, visit 3 and visit 5 a Pap smear test will be done. At the enrollment visit, study participants will complete a questionnaire designed to assess social and behavioral risk factors for the acquisition of HPV. At each subsequent study visit, participants will be asked to provide updated information to assess changes in risk behaviors such as condom use, relations with new partners, and tobacco use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Female Partners | Female partners of HIM Study participants |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of men in the HIM study willing to invite their female partner to participate in partner study, proportion of female partners who: a) contact clinic for enrollment in study b) are eligible to participate in the study c) enroll in study. | 2 year accrual period |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of female partners who report being monogamous with the HIM partner, proportion of women that are both HPV sero negative and HPV DNA negative at enrollment, proportion of women who comply with study protocol over 2 years of follow up. | 2 years per participant |
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Inclusion Criteria:
Exclusion Criteria:
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Female partners of HIM Study participants - Companion study to MCC-13930. Residents of Southern Florida.
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| Name | Affiliation | Role |
|---|---|---|
| Anna Giuliano | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D009369 | Neoplasms |
| D063646 | Carcinogenesis |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |