Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048282
Status:
COMPLETED
Last Update Posted:
2010-05-14
First Post:
2002-10-29
Brief Title:
HIV Prevention Preparedness Study
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
HIV Prevention Preparedness Study
Status:
COMPLETED
Status Verified Date:
2006-01
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:
The purpose of this study is to provide researchers with information that will help them prepare for a future study to test the efficacy of two anti-HIV vaginal gels This study will also estimate how likely people living in certain areas are to become infected with HIV and other infections passed during sex
Detailed Description:
This study is designed to prepare for the implementation of a second study HPTN 035 A Phase IIIII Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and PRO 20005 Gel P for the Prevention of HIV Infection in Women HPTN 035 requires an average HIV seroincidence rate of 5-6 percent among enrolled participants The primary objective of the present study is to estimate the rates of HIV seroincidence among women targeted for inclusion in HPTN 035
Women will be enrolled in this study for 6 to 12 months Study visits will take place monthly At each visit participants will complete a medicalmenstrual history and undergo pregnancy testing Each quarter participants will undergo a structured interview about sexual practices and will receive HIV and STD tests education and counseling Participants will also undergo a pelvic exam with wet mount testing for bacterial vaginosis candidiasis and trichomoniasis Colposcopic evaluations will be performed at selected sites Pap smears will be performed at sites with the capacity and expertise to prepare and interpret the smears and provide appropriate follow-up care to participants with abnormal results
Women will be enrolled in this study for 6 to 12 months Study visits will take place monthly At each visit participants will complete a medicalmenstrual history and undergo pregnancy testing Each quarter participants will undergo a structured interview about sexual practices and will receive HIV and STD tests education and counseling Participants will also undergo a pelvic exam with wet mount testing for bacterial vaginosis candidiasis and trichomoniasis Colposcopic evaluations will be performed at selected sites Pap smears will be performed at sites with the capacity and expertise to prepare and interpret the smears and provide appropriate follow-up care to participants with abnormal results
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