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Accelerated ART Initiation for PWHIV Who Are Out of Care

ConditionsHIV InfectionsARTNoncompliance, Patient
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • The Accelerate model of care

    Other intervention

    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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Accelerate Model of CareExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24.

Proportion of participants who have plasma HIV RNA \<200 c/mL at Week 24 (observed analysis)

Time frame
24 weeks
2

To study the change over time in the acceptability of the ACCELERATE model of care in patient and staff participants.

Quantitative Change in the mean scores of the Acceptability of Intervention Measure (AIM) scores at Weeks 24, and 48 by PLWH Change in the mean scores of the Acceptability of Intervention Measure (AIM)scores from baseline at Week 48 by Staff participants. Min score: 4 (worst) Max score: 20 (best)

Time frame
1 year
3

To study the change over time in appropriateness of the ACCELERATE model of care in patient and staff participants

Quantitative Change in the mean scores of the Intervention Appropriateness Measure (IAM) scores at Weeks 24, and 48 by PLWH Change in the mean scores of the Intervention Appropriateness Measure (IAM) scores from baseline at Week 48 by Staff participants. Min score: 4 (worst) Max score: 20 (best)

Time frame
1 year
4

To study the change over time in feasibility of the ACCELERATE model of care in staff participants

Quantitative Change in the mean scores of the Feasibility of Intervention Measure (FIM) scores from baseline at Weeks 24, and 48 by PLWH Change in the mean scores of the Feasibility of Intervention Measure (FIM) scores from baseline at Week 48 by Staff participants. Min score: 4 (worst) Max score: 20 (best)

Time frame
1 year

Secondary outcomes

1

To evaluate the effectiveness of the intervention to achieve HIV viral suppression at week 48 using ACCELERATE model of care.

The proportion of participants who * Have HIV RNA \<50 c/mL at Week 24 and 48 (observed analysis) * Have HIV RNA \<50 c/mL at Week 24 and 48 using Intent-to-treat (ITT) analysis, including all participants who have received at least one dose of B/F/TAF.

Time frame
1 year
2

To assess change in patient experience (PROs) and satisfaction for participants using the ACCELERATE model of care

Change from baseline in overall Consumer Assessment of Healthcare Providers and Systems-Clinician and Group (CAHPS®-CG)19 at Weeks 24, and 48. The CG-CAHPS Adult Visit Survey contains 42 items, of which 13 are used to create three composites which assess Access to Care (five items), Doctor Communication (six items), and Courteous/Helpful Staff (two items). The survey also includes two questions that ask respondents (1) to rate their doctor, and (2) report if they would recommend the doctor's office to family and friends. In addition, respondents are asked about their overall health, age, gender, and education. Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3480671/

Time frame
1 year
3

To assess change in health-related quality of life (HRQoL)

Change from baseline in Physical Component Summary (PCS) score and \& Mental Component Summary (MCS) of the Short Form (SF-36®)20 at Weeks 24, and 48. Min score: 0 (worst) Max score: 3600 (best) source: https://www.rand.org/health-care/surveys\_tools/mos/36-item-short-form/scoring.html

Time frame
1 year
4

To measure the change in patients' satisfaction with the HIV treatment regimen B/F/TAF

Change from week 4 in the overall score of the treatment Satisfaction Questionnaire21 at Weeks 24, and 48. To account for a potential ceiling effect that may occur due to the baseline, the appropriate version of the HIV treatment satisfaction questionnaire (HIVTSQ) (status or change) will be used. Min score: 0 (worst) Max score: 60 (best)

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Missouri-Columbia

Lead sponsor

Gilead Sciences

Collaborator

Source ClinicalTrials.gov
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