NCT06374758 · University of Missouri-Columbia
Accelerated ART Initiation for PWHIV Who Are Out of Care
(ACCELERATE)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
The 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.
DRUG
bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg
Same as above, it is the same intervetion
Primary outcome measures
The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24.
Time frame: 24 weeks
Proportion of participants who have plasma HIV RNA \<200 c/mL at Week 24 (observed analysis)
To study the change over time in the acceptability of the ACCELERATE model of care in patient and staff participants.
Time frame: 1 year
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)
To study the change over time in appropriateness of the ACCELERATE model of care in patient and staff participants
Time frame: 1 year
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)
To study the change over time in feasibility of the ACCELERATE model of care in staff participants
Time frame: 1 year
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)
To study the change over time in sustainability of the ACCELERATE model of care in staff participants
Time frame: 1 year
Quantitative Mean overall score of Clinical Sustainability Assessment Tool (CSAT) and change from baseline at Week 48 by Staff participants. Min score: 0 (worst) Max score: 147 (best)
Qualitative data
Time frame: 1 year
One-on-one Semi-structured interviews with PLWH and Staff Participants at end of study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 ART for ≥1 month (by self-report) Site Staff Inclusion criteria: Participants must meet ALL the following inclusion criteria 1. 18 years or older at the time of obtaining the informed consent 2. HIV care providers, case managers, pharmacists, or administrators involved in administrative or clinical aspects of the intervention at participating sites 3. Understand the long-term commitment to the
Where
- Columbia, Missouri
- Kansas City, Missouri
- Springfield, Missouri
- St Louis, Missouri
Collaborators
Gilead Sciences
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2025 · Source of record for eligibility and locations