Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-03 @ 10:48 AM
Study NCT ID:
NCT03058835
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2017-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project
Sponsor:
Rutgers, The State University of New Jersey
Organization:
Study Overview
Official Title:
IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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 overall aim of this study is to assess attitudes toward PrEP, feasibility of Truvada PrEP procurement through the established access procedures, and adherence to Truvada PrEP among US women at risk for HIV acquisition.
Detailed Description:
Study Design:
This is a 24 week prospective pilot study assessing attitudes toward and feasibility of using Truvada PrEP in a population of women at risk for HIV acquisition.At this site 31 HIV- uninfected women desiring PrEP will be enrolled at each site (confirm number). We will have to consent about 50 women which includes screen failures.The study will assess attitudes towards and adherence to PrEP with questionnaires at weeks 12 and 24. Tenofovir levels procured at week 12 and 24 week of PrEP will be used to assess adherence to PrEP.
Primary objectives:
1. Describe attitudes toward PrEP among a population of women at risk for HIV acquisition, living in HIV prevalent areas.
2. Assess feasibility of Truvada procurement through the established Gilead access program
3. Evaluate adherence at week 12 and week 24 using dried blood spots
Secondary objective:
1. Describe HIV incidence
2. Describe associations of positive and negative attitudes toward PrEP with acceptance of PrEP and subsequent adherence
3. Assess adherence at weeks 12 and 24
4. Evaluate the relationship between PrEP adherence and sexual activity
5. Compare geographic areas with respect to PrEP attitudes
6. Mentor junior investigators at each site.
This is a 24 week prospective pilot study assessing attitudes toward and feasibility of using Truvada PrEP in a population of women at risk for HIV acquisition.At this site 31 HIV- uninfected women desiring PrEP will be enrolled at each site (confirm number). We will have to consent about 50 women which includes screen failures.The study will assess attitudes towards and adherence to PrEP with questionnaires at weeks 12 and 24. Tenofovir levels procured at week 12 and 24 week of PrEP will be used to assess adherence to PrEP.
Primary objectives:
1. Describe attitudes toward PrEP among a population of women at risk for HIV acquisition, living in HIV prevalent areas.
2. Assess feasibility of Truvada procurement through the established Gilead access program
3. Evaluate adherence at week 12 and week 24 using dried blood spots
Secondary objective:
1. Describe HIV incidence
2. Describe associations of positive and negative attitudes toward PrEP with acceptance of PrEP and subsequent adherence
3. Assess adherence at weeks 12 and 24
4. Evaluate the relationship between PrEP adherence and sexual activity
5. Compare geographic areas with respect to PrEP attitudes
6. Mentor junior investigators at each site.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IN-US-276-1340 | OTHER | Gilead Sciences Inc. | View |