Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04880200
Status:
RECRUITING
Last Update Posted:
2023-04-28
First Post:
2021-04-27
Brief Title:
Improving HIV Diagnosis Linkage to Care and Prevention Services With HIV Point-of-Care Nucleic Acid Tests
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
The GAIN Greater Access and Impact With NAT Study Improving HIV Diagnosis Linkage to Care and Prevention Services With HIV Point-of-Care Nucleic Acid Tests NATs
Status:
RECRUITING
Status Verified Date:
2023-04
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:
GAIN
Brief Summary:
This project will develop implement and evaluate models for use of point-of-care nucleic acid testing POC NAT among HIV-negative persons seeking HIV testing PEP and PrEP and HIV-positive persons in community and clinical settings Study aims 1 and 2 will evaluate the sensitivity and specificity of a qualitative POC NAT in persons not known to be HIV-positive and will determine the impact of its use on PrEP uptake and persistence among persons testing HIV-negative and on time to HIV continuum of care outcomes among persons testing HIV-positive Aim 3 will implement a POC NAT-tailored behavioral intervention to evaluate impact on time to virologic suppression among PLWH receiving ART Aim 4 will quantify the acceptability and feasibility of implementation of POC NAT in community and clinical settings and collect cost and related data for cost-effectiveness analyses Finally in Aim 5 a distinct but related study will compare the sensitivity specificity and agreement of multiple POC NATs over a range of HIV RNA levels
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 6 U01 PS 005196-01-01 | OTHER_GRANT | CDC | None |