Accelerated ART Initiation for PWHIV Who Are Out of Care (NCT06374758) | Clinical Trial Compass
RecruitingPhase 4
Accelerated ART Initiation for PWHIV Who Are Out of Care
United States120 participantsStarted 2024-04-29
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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)
✓. Out of care, defined as not had a medical visit with an HIV care provider with prescribing privileges for ≥6 months AND not receiving ART for ≥1 month (by self-report)
✓. 18 years or older at the time of obtaining the informed consent
✓. HIV care providers, case managers, pharmacists, or administrators involved in administrative or clinical aspects of the intervention at participating sites
✓. Understand the long-term commitment to the study and be willing to participate
Exclusion criteria
✕. 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)
What they're measuring
1
The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24.
Timeframe: 24 weeks
2
To study the change over time in the acceptability of the ACCELERATE model of care in patient and staff participants.
Timeframe: 1 year
3
To study the change over time in appropriateness of the ACCELERATE model of care in patient and staff participants
Timeframe: 1 year
4
To study the change over time in feasibility of the ACCELERATE model of care in staff participants
Timeframe: 1 year
5
To study the change over time in sustainability of the ACCELERATE model of care in staff participants
✕. Concomitant use of contraindicated medications: using drug interaction database either Lexicomp® Drug Interactions (category X Avoid combination) or Liverpool HIV Interactions Checker (category Do not Co-administer) or study drug label (USPI) as reference for list of contraindicated meds.
✕. Pregnant (by self-report) or planning to become pregnant while enrolled in the study
✕. HIV-2 infection
✕. PLWH who are breastfeeding and are not on ART or taking ART without virologic suppression since breastfeeding will not be recommended.