Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06374758

ACCELERATE: A Multisite Study of a Simplified Accelerated ART Start Protocol for People With HIV Who Are Out of Care

Led by University of Missouri-Columbia · Updated on 2025-04-20

120

Participants Needed

4

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

University of Missouri-Columbia

Lead Sponsor

G

Gilead Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the ACCELERATE model of care to help people with HIV who are out of care achieve viral suppression by Week 24. This study focuses on a simplified approach that includes outreach, telehealth access to an HIV provider, a pre-approved HIV treatment regimen, and a free 30-day medication starter pack. The study also examines how acceptable, appropriate, feasible, and sustainable this model is for both patients and staff. The ACCELERATE model starts with the study team establishing contact and providing a telehealth appointment with an HIV care provider within 24 business hours. Eligible participants are enrolled and prescribed bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), which is mailed as a free 30-day starter pack. Follow-up calls occur within 2 to 4 weeks to check for side effects and adherence. Patients are then connected to an HIV clinic for ongoing care within 4 weeks, where lab tests may be performed as needed. Participants will have various assessments including monitoring HIV viral load at Week 24 to measure viral suppression. The study also tracks patient and staff experiences, satisfaction, quality of life, retention in care, and adherence over one year. Data on staff workload and burnout will be collected. Participants can expect regular evaluations, telephone follow-ups, and lab tests during their participation, which lasts at least 24 weeks with ongoing observation up to one year.

CONDITIONS

Brief Title

Accelerated ART Initiation for PWHIV Who Are Out of Care

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older at the time of informed consent
  • Speaks English
  • Able to understand and comply with study requirements
  • Documented HIV-1 infection by positive test
  • Out of care for at least 6 months and not on ART for at least 1 month
  • HIV care providers, case managers, pharmacists, or administrators involved in the intervention at participating sites
  • Willing and able to participate and complete assessments for the study duration
Not Eligible

You will not qualify if you...

  • Contraindication or not recommended to use Biktarvy (B/F/TAF)
  • Chronic kidney disease with creatinine clearance <30 mL/min and not on dialysis
  • Allergy to B/F/TAF components
  • Known intermediate-high level resistance to B/F/TAF components
  • Use of contraindicated medications interacting with B/F/TAF
  • Pregnant or planning pregnancy during the study
  • HIV-2 infection
  • Breastfeeding and not on ART or without virologic suppression
  • Active opportunistic infections requiring delay of ART
  • Not residing in Missouri or planning to relocate during study
  • Incarcerated at time of enrollment
  • Site staff planning job relocation within 1 year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Treatment

Duration - 24 weeks

Participants start the Accelerate model of care involving a telehealth appointment with an HIV care provider, rapid prescription of the ART regimen B/F/TAF, and receiving a free 30-day starter pack mailed to them.

1 initial telehealth visit and 1 telephone follow-up call within 2 to 4 weeks

Follow-up

Duration - Up to 1 year

Participants transition to hand-off and established care at an HIV clinic with lab monitoring and ongoing assessments of viral suppression, adherence, and patient and staff experience.

Periodic clinic visits as determined by the HIV care provider during the year

Trial Site Locations

Total: 4 locations

1

University of Missouri-Columbia

Columbia, Missouri, United States, 65212

Actively Recruiting

2

KC Care Health Center

Kansas City, Missouri, United States, 64124

Actively Recruiting

3

AIDS Project of the Ozarks

Springfield, Missouri, United States, 65804

Actively Recruiting

4

NOVUS Health

St Louis, Missouri, United States, 63111

Actively Recruiting

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Research Team

D

Dima Dandachi, MD, MPH

H

Hilal Abdessamad, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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