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Antiretroviral Therapy

Accelerate Model of Care for Nonadherence (ACCELERATE Trial)

Phase 4

Recruiting

Led By Dima Dandachi, MD, MPH

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older at the time of obtaining the informed consent

HIV-1 infection as documented by positive HIV test (positive laboratory HIV 1/2 Antibody differentiation assay or detectable HIV -1 RNA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

ACCELERATE Trial Summary

This trial aims to see if the ACCELERATE model of care is effective in achieving HIV viral suppression at Week 24. The study will also look into whether this model is acceptable, appropriate, feasible

Who is the study for?

This trial is for people living with HIV who are not currently receiving care. Participants should be willing to try a new model of care called ACCELERATE, which includes outreach, telehealth services, a simplified HIV treatment regimen, and support for re-linking to medical care.Check my eligibility

What is being tested?

The study tests the effectiveness of the ACCELERATE model in achieving HIV viral suppression by Week 24. It involves rapid access to healthcare via telehealth and starting patients on a pre-approved medication regimen (bictegravir/emtricitabine/tenofovir alafenamide).See study design

What are the potential side effects?

Potential side effects from the medication bictegravir/emtricitabine/tenofovir alafenamide may include headache, diarrhea, nausea, fatigue and rare but serious risks like lactic acidosis or liver problems.

ACCELERATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am HIV positive, confirmed by a lab test.

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I am 18 years old or older.

ACCELERATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Qualitative data

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

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

+3 more

Secondary outcome measures

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

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

To assess staff impact of ACCELERATE model of care on staff burnout

+7 more

ACCELERATE Trial Design

1Treatment groups

Experimental Treatment

Group I: Accelerate Model of CareExperimental Treatment2 Interventions

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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor

362 Previous Clinical Trials

627,999 Total Patients Enrolled

Gilead SciencesIndustry Sponsor

1,084 Previous Clinical Trials

848,142 Total Patients Enrolled

Dima Dandachi, MD, MPHPrincipal InvestigatorUniversity of Missouri-Columbia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for participants in this clinical trial?

"According to the information available on clinicaltrials.gov, this research is currently seeking volunteers. The trial was initially disclosed on May 1st, 2024 and last revised on April 15th of the same year."

Answered by AI

What is the current sample size of patients participating in this research investigation?

"Indeed, information on clinicaltrials.gov highlights the ongoing recruitment of participants for this particular trial. Originally shared on May 1st, 2024, and subsequently updated on April 15th, 2024, the study aims to enroll a total of 120 individuals at one designated site."

Answered by AI

What are the risks associated with the Accelerate Model of Care for individuals?

"Given that this is a Phase 4 trial and the Accelerate Model of Care has already met regulatory approval, our team ranks its safety at the highest level of 3."

Answered by AI

What specific objectives does this medical study aim to fulfill?

"The principal aim of this investigation, to be evaluated over approximately 24 weeks, is to scrutinize the evolution in acceptability of the ACCELERATE care model among patient and staff participants. Secondary goals encompass analyzing the immunological reaction through B/F/TAF as a primary treatment regimen within the ACCELERATE framework. This involves assessing alterations from baseline/week 4 in CD4 cell counts at Weeks 24 and 48. Furthermore, evaluating variations in health-related quality of life (HRQoL) entails determining changes from baseline in Physical Component Summary (PCS) score & Mental Component Summary (MCS) derived from Short Form-"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Accelerated ART Initiation for PWHIV Who Are Out of Care

Dima Dandachi 2024. "Accelerated ART Initiation for PWHIV Who Are Out of Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06374758.

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