Ignite Creation Date:
2024-05-05 @ 9:10 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00823511
Status:
COMPLETED
Last Update Posted:
2015-01-28
First Post:
2009-01-13
Brief Title:
The Human Papillomavirus HPV Transmission Pilot Study
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
The Human Papillomavirus HPV Transmission Pilot Study
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| USF IRB 104923 | None | None | None |