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Accelerated ART Initiation for PWHIV Who Are Out of Care — ACCELERATE  

HIV Infections Clinical Trial

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.

Clinical Trial 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.

Clinical Trial 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 copies/mL at week 24 with B/F/TAF (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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06374758
Study type Interventional
Source University of Missouri-Columbia
Contact Dima Dandachi, MD, MPH
Phone (573) 882-7746
Email dandachid@health.missouri.edu
Status Recruiting
Phase Phase 4
Start date April 29, 2024
Completion date November 1, 2025
View Details
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