RecruitingPhase 4NCT06374758

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.

Sponsor

University of Missouri-Columbia

Enrollment

120 participants

Start Date

Apr 29, 2024

Study Type

INTERVENTIONAL

Conditions

HIV Infections ART Noncompliance, Patient

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether helping people living with HIV who have fallen out of care get back on their antiretroviral therapy (ART) more quickly — through an accelerated, same-day or next-day prescription model — improves their health outcomes. **You may be eligible if...** - You are 18 or older and living with HIV - You speak English - You have not seen an HIV doctor or received ART for at least 6 months (you are "out of care") **You may NOT be eligible if...** - You do not meet the definition of "out of care" (i.e., you have seen an HIV provider and received ART within the past 6 months) - You are unable to understand or follow study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERThe 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.

DRUGbictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg

Same as above, it is the same intervetion