Accelerated ART Initiation for PWHIV Who Are Out of Care
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Missouri-Columbia
About this trial
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 criteria
Qualifiers
18 years or older at the time of obtaining the informed consent
Speaks English
Able to give consent which includes the ability to understand and comply with study requirements and instructions as judged by clinic or study staff
HIV-1 infection as documented by positive HIV test (positive laboratory HIV 1/2 Antibody differentiation assay or detectable HIV -1 RNA)
Disqualifiers
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
Known history of allergy to B/F/TAF components
Known history of intermediate-high level resistance to B/F/TAF components (score ≥30 on Stanford HIV Drug Resistance Algorithm) in the available medical record (not having a prior genotype or having M184V/I mutation is NOT an exclusion criterion)
Trial design
Treatments tested in this trial
- The Accelerate model of care
- bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Missouri-Columbia
Lead sponsor
Gilead Sciences
Collaborator
Source ClinicalTrials.gov