Actively Recruiting
Accelerated ART Initiation for PWHIV Who Are Out of Care
Led by University of Missouri-Columbia · Updated on 2025-04-20
120
Participants Needed
4
Research Sites
130 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
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.
CONDITIONS
Official 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 consent
- Speaks English
- Able to give informed consent and comply with study instructions
- Confirmed HIV-1 infection by positive HIV test or detectable HIV-1 RNA
- Out of care: no medical visit with an HIV provider for 6 months and not on ART for at least 1 month
- Site staff must be 18 years or older
- Site staff must be HIV care providers, case managers, pharmacists, or administrators involved in the intervention
- Site staff must understand study commitment and be willing to participate
- Site staff must have resources to complete study assessments
You will not qualify if you...
- Contraindication or not recommended to take Biktarvy (B/F/TAF), including:
- Chronic kidney disease with creatinine clearance under 30 mL/min and not on dialysis
- Allergy to B/F/TAF components
- Known intermediate-high resistance to B/F/TAF components (score ≥30 on resistance algorithm)
- Taking contraindicated medications as listed in drug interaction databases or drug label
- Pregnant or planning pregnancy during study
- HIV-2 infection
- Breastfeeding without virologic suppression or not on ART
- Active opportunistic infections requiring ART delay (e.g., cryptococcal or tuberculous meningitis, CMV retinitis)
- Not living in Missouri or planning to relocate during study
- Currently incarcerated at enrollment
- Site staff planning to relocate or change job within 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
H
Hilal Abdessamad, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here