Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374758
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-27
Brief Title:
Accelerated ART Initiation for PWHIV Who Are Out of Care
Sponsor:
University of Missouri-Columbia
Organization:
University of Missouri-Columbia
Study Overview
Official Title:
ACCELERATE a Multisite Prospective Hybrid Effectiveness-implementation Type 2 Design Single-arm Mixed-methods Study of a Simplified Accelerated ART Initiation Protocol for People With HIV Who Are Out of Care
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ACCELERATE
Brief Summary:
The main purpose of the study is to evaluate the effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24 The study will also assess the acceptability appropriateness feasibility and sustainability of the ACCELERATE model of care The ACCELERATE model combines a standardized method for outreach the use of telehealth for rapid access to an HIV care provider a simplified pre-approved HIV regimen a free 30-day medication starter supply and re-linkage to medical care
Detailed Description:
This is a multisite prospective hybrid effectiveness-implementation type 2 design single-arm mixed-methods study of a simplified accelerated ART initiation protocol for People with HIV who are out of care
The investigators will assess the effectiveness of achieving HIV viral suppression defined as HIV RNA 200 copiesmL at week 24 with BFTAF Biktarvy as a rapid start for PWH who are out of care
The investigators will also study the acceptability feasibility and sustainability of an innovative model of care that combines a standardized method for outreach the use of telehealth for rapid access to an HIV care provider a simplified pre-approved ART regimen a mailed free starter and re-linkage to care As an implementation science study the investigators will explore the methods and factors influencing the successful integration of evidence-based practices across diverse settings
This study will also ask the staff implementing the ACCELERATE approach about its ease of use feasibility compliance and possible obstacles to its application
The investigators will assess the effectiveness of achieving HIV viral suppression defined as HIV RNA 200 copiesmL at week 24 with BFTAF Biktarvy as a rapid start for PWH who are out of care
The investigators will also study the acceptability feasibility and sustainability of an innovative model of care that combines a standardized method for outreach the use of telehealth for rapid access to an HIV care provider a simplified pre-approved ART regimen a mailed free starter and re-linkage to care As an implementation science study the investigators will explore the methods and factors influencing the successful integration of evidence-based practices across diverse settings
This study will also ask the staff implementing the ACCELERATE approach about its ease of use feasibility compliance and possible obstacles to its application
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None