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Antiretroviral Therapy

Accelerated ART Initiation for HIV (ACCELERATE Trial)

Phase 4

Recruiting

Led By Dima Dandachi, MD, MPH

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older at the time of obtaining the informed consent

HIV-1 infection as documented by positive HIV test (positive laboratory HIV 1/2 Antibody differentiation assay or detectable HIV -1 RNA)

Must not have

Biktarvy (B/F/TAF) contraindicated or not recommended

Known history of chronic kidney disease (creatinine clearance <30 mL/min) using Cockcroft-Gault formula AND not on chronic dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial aims to see if the ACCELERATE model of care is effective in achieving HIV viral suppression at Week 24. The study will also look into whether this model is acceptable, appropriate, feasible

Who is the study for?

This trial is for people living with HIV who are not currently receiving care. Participants should be willing to try a new model of care called ACCELERATE, which includes outreach, telehealth services, a simplified HIV treatment regimen, and support for re-linking to medical care.

What is being tested?

The study tests the effectiveness of the ACCELERATE model in achieving HIV viral suppression by Week 24. It involves rapid access to healthcare via telehealth and starting patients on a pre-approved medication regimen (bictegravir/emtricitabine/tenofovir alafenamide).

What are the potential side effects?

Potential side effects from the medication bictegravir/emtricitabine/tenofovir alafenamide may include headache, diarrhea, nausea, fatigue and rare but serious risks like lactic acidosis or liver problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am HIV positive, confirmed by a lab test.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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Biktarvy is not suitable for my treatment.

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I have chronic kidney disease but am not on dialysis.

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I am infected with HIV-2.

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I am breastfeeding, not on ART, or my ART is not working.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Qualitative data

The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24.

To study the change over time in appropriateness of the ACCELERATE model of care in patient and staff participants

+3 more

Secondary study objectives

To assess change in health-related quality of life (HRQoL)

To assess change in patient experience (PROs) and satisfaction for participants using the ACCELERATE model of care

To assess staff impact of ACCELERATE model of care on staff burnout

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Accelerate Model of CareExperimental Treatment2 Interventions

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.

0 / 7Eligibility criteria met