Accelerated ART Initiation for PWHIV Who Are Out of Care (NCT06374758) | Clinical Trial Compass
Active — Not 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is testing the ACCELERATE model of care for people with HIV who have fallen out of regular care, could you help me understand whether my specific situation — like how long I've been out of care — would make this approach a good fit for me to discuss with the team?
2This is a Phase 4 trial focused on getting people onto antiretroviral therapy quickly, so what does 'accelerated ART initiation' actually mean in practice — like how soon would I start medication compared to the standard process at your clinic?
3The trial is measuring viral suppression at 24 weeks as its main goal — based on what you know about my current viral load and health status, is that a realistic and meaningful target for my situation?
4Since the trial is actively enrolling but no longer recruiting new participants, does that mean this specific program is no longer available to me, and if so, are there similar fast-track HIV care models at this clinic I could still access?
5The study also measures how acceptable and feasible this care model is for both patients and staff — what does that mean for the kind of support and follow-up I'd receive, and how much time and visits would this realistically require from me over those 24 weeks?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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)
. 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.