Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121459
Status:
WITHDRAWN
Last Update Posted:
2015-03-04
First Post:
2005-07-12
Brief Title:
Effectiveness of the Diaphragm for HIV Prevention
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
The Latex Diaphragm to Prevent HIV Acquisition Among Women A Female-Controlled Physical Barrier of the Cervix
Status:
WITHDRAWN
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left and no data or information is available
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 trial is to determine whether using the diaphragm and a lubricant get can reduce womens risk of acquiring an HIV infection
Detailed Description:
This multi-site randomized controlled trial will measure the effectiveness of the diaphragm in preventing heterosexual acquisition of HIV infection among women This Phase III study is powered to detect effectiveness biological efficacy combined with adherence of 33 percent Women in South Africa and Zimbabwe N4500 at risk of contracting HIV will be invited to participate and will be followed for up to 24 months with a total study duration of 4 years All women will receive safer-sex counseling free male condoms and diagnosis and treatment of sexually transmitted infections STIs Half of the participants will be randomly selected to receive an Ortho All-Flex latex diaphragm and Replens lubricant gel We will assess whether women using diaphragms and lubricant gel have lower rates of HIV or STI infection than do their non-diaphragm and gel counterparts Additionally we will investigate the long-term acceptability of the diaphragm in this study population
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 |
|---|---|---|---|
| 21082 | None | None | None |