ACCELERATE a Multisite Prospective Hybrid (Effectiveness-implementation) Type 2 Design, Single-arm, Mixed-methods Study of a Simplified Accelerated ART Initiation Protocol for People With HIV Who Are Out of Care.
University of Missouri-Columbia
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.
Description
This is a multisite prospective hybrid (effectiveness-implementation) type 2 design, single-arm, mixed-methods study of a simplified accelerated ART initiation protocol for People with HIV who are out of care. The investigators will assess the effectiveness of achieving HIV viral suppression defined as HIV RNA \< 200 copies/mL at week 24 with B/F/TAF (Biktarvy) as a rapid start for PWH who are out of care. The investigators will also study the acceptability, feasibility, and sustainability of an innovative model of care that combines a standardized method for outreach, the use of telehealth…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
PLWH Inclusion criteria: Participants must meet ALL the following inclusion criteria 1. 18 years or older at the time of obtaining the informed consent 2. Speaks English 3. Able to give consent which includes the ability to understand and comply with study requirements and instructions as judged by clinic or study staff 4. HIV-1 infection as documented by positive HIV test (positive laboratory HIV 1/2 Antibody differentiation assay or detectable HIV -1 RNA) 5. Out of care, defined as not had a medical visit with an HIV care provider with prescribing privileges for ≥6 months AND not receiving…
Interventions
- OtherThe Accelerate model of care
Contact is established by the study team The patient is provided with a telehealth appointment with an HIV care provider within 24 business hours of contact At the time of enrollment/initial clinic visit, patients who meet the inclusion and exclusion criteria will be enrolled in the study The HIV care provider will prescribe B/F/TAF to their pharmacy of choice. B/F/TAF is dispensed by the designated study pharmacist and mailed to the patient as a free 30-day starter pack to allow time for benefits verification. A telephone follow-up call by the study team will be conducted within 2 - 4 weeks from the initial clinical visit to assess any adverse events, tolerability, and adherence. Hand-off to HIV clinic to establish care within 4 weeks. Lab results will be drawn during clinic per HIV care provider which might include CBC, CMP, HIV-1 RNA, CD4, and genotype resistance testing when clinically indicated by the HIV care provider.
- Drugbictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg
Same as above, it is the same intervetion
Locations (4)
- University of Missouri-ColumbiaColumbia, Missouri
- KC Care Health CenterKansas City, Missouri
- AIDS Project of the OzarksSpringfield, Missouri
- NOVUS HealthSt Louis, Missouri