Accelerated ART Initiation for PWHIV Who Are Out of Care

Part of paid clinical trials in Columbia, Missouri.

Sponsor
University of Missouri-Columbia
Study ID
NCT06374758
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The Accelerate model of care — OTHER
    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.
  • bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg — DRUG
    Same as above, it is the same intervetion

Study Details

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.

Key Dates

Start date
Apr 29, 2024
Status verified
Apr 2025
Primary completion
May 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: 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.

Primary Outcome Measure

The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. [ Time Frame: 24 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Missouri-ColumbiaColumbiaMissouri65212
Dima Dandachi, MD
[email protected]
573-884-8728
KC Care Health CenterKansas CityMissouri64124
Blair Thedinger, MD
[email protected]
816-777-2770
AIDS Project of the OzarksSpringfieldMissouri65804
Stephen Adams, MD
[email protected]
417-881-1300
NOVUS HealthSt LouisMissouri63111
Mark Scheperle, MD
[email protected]
314-575-3838

Find similar trials in Columbia, MO

By condition
HIV
By specialty
Infectious disease
By research site
University of Missouri-Columbia· Columbia, MOKC Care Health Center· Kansas City, MOAIDS Project of the Ozarks· Springfield, MONOVUS Health· St Louis, MO

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