NCT06374758

Accelerated ART Initiation for PWHIV Who Are Out of Care

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• HIV Infections
• ART
• Noncompliance, Patient

Interventions

Type	Name	Description
OTHER	The Accelerate model of care	Contact is established by the study team The patient is provided with a telehealth appointment with an HIV care provider within 24 business hours of contact At the time of enrollment/initial clinic visit, patients who meet the inclusion and exclusion criteria will be enrolled in the study The HIV care provider will prescribe B/F/TAF to their pharmacy of choice. B/F/TAF is dispensed by the designated study pharmacist and mailed to the patient as a free 30-day starter pack to allow time for benefits verification. A telephone follow-up call by the study team will be conducted within 2 - 4 weeks from the initial clinical visit to assess any adverse events, tolerability, and adherence. Hand-off to HIV clinic to establish care within 4 weeks. Lab results will be drawn during clinic per HIV care provider which might include CBC, CMP, HIV-1 RNA, CD4, and genotype resistance testing when clinically indicated by the HIV care provider.
DRUG	bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg	Same as above, it is the same intervetion

Timeline

• Start date: 2024-04-29
• Primary completion: 2026-05-01
• Completion: 2026-11-01
• First posted: 2024-04-19
• Last updated: 2025-04-20

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study