Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
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
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
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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