Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT01334827
Status:
COMPLETED
Last Update Posted:
2025-10-15
First Post:
2011-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Formative Study to Explore the Sensory Perceptions of Vaginal Product Users
Sponsor:
The Miriam Hospital
Organization:
Study Overview
Official Title:
Rational Development of Combination Microbicide Therapies: A Formative Study to Explore the Sensory Perceptions of Vaginal Product Users (Project MIST)
Status:
COMPLETED
Status Verified Date:
2025-10
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:
Project-MIST
Brief Summary:
The purpose of the study is to compare, contrast, and characterize the range of user perceptions and potential acceptability of three (3) topical vaginal microbicide dosage forms.
Detailed Description:
The success of microbicide products will derive from the synergy of their biological functionality and user acceptability. Biological functionality is the integrated result of safe and effective anti-HIV compounds incorporated into dosage forms or devices that successfully deliver those compounds to target tissues, fluids, and pathogens. Acceptability is a multi-factorial phenomenon that accounts for the personal, dyadic, product-related, and social contexts that potentiate - or not - a woman's decision to use a microbicide. Acceptability (assessed, in part, by the users' sensory perceptions of products during use) depends strongly upon dosage forms and/or delivery systems with biophysical functions and/or mechanical and materials properties that are most conducive to human use. Without both, microbicides' potential to decisively alter the public health impact of HIV/AIDS and other sexually transmitted infections will be largely limited. The current protocol will specifically study the impact of gel volume on user perceptions, as well as extend user perception scale development to include those properties and product "behaviors" experienced when using a vaginal film.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R33AI076967 | NIH | None | https://reporter.nih.gov/quic… | View |