Accelerated care model for people with HIV who are not receiving treatment

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.

This study tests a new care model to see if it can help people with HIV who haven't been in treatment get back on track and achieve better health using easier medication and telehealth support.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Missouri-Columbia (Academic / other)
• Locations: 4 sites (Columbia, Missouri and 3 other locations)
• Trial ID: NCT06374758 on ClinicalTrials.gov

What this trial studies

This study evaluates the ACCELERATE model of care aimed at achieving HIV viral suppression in individuals who have been out of care. It employs a hybrid design to assess both the effectiveness of a simplified ART regimen and the implementation of telehealth for rapid access to care. Participants will receive a free 30-day medication starter supply and be re-linked to medical care. The study also explores the acceptability and feasibility of this innovative approach across various settings.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are living with HIV, have not received medical care for at least six months, and are not currently on ART.

Not a fit: Patients who are currently receiving ART or have had a medical visit with an HIV care provider in the past six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve access to HIV treatment and viral suppression for individuals who have been disengaged from care.

How similar studies have performed: Other studies have shown promise with similar outreach and telehealth approaches, indicating potential for success in this novel model.

Eligibility criteria

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 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 study and be willing to participate
4. Have adequate resources to complete assessments for the duration of the study

Exclusion criteria PLWH Exclusion criteria: Participants who meet ANY of the following criteria are excluded

1. Biktarvy (B/F/TAF) contraindicated or not recommended

   1. Known history of chronic kidney disease (creatinine clearance \<30 mL/min) using Cockcroft-Gault formula AND not on chronic dialysis
   2. Known history of allergy to B/F/TAF components
   3. 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)
   4. Concomitant use of contraindicated medications: using drug interaction database either Lexicomp® Drug Interactions (category X Avoid combination) or Liverpool HIV Interactions Checker (category Do not Co-administer) or study drug label (USPI) as reference for list of contraindicated meds.
   5. Pregnant (by self-report) or planning to become pregnant while enrolled in the study
2. HIV-2 infection
3. PLWH who are breastfeeding and are not on ART or taking ART without virologic suppression since breastfeeding will not be recommended.
4. Active opportunistic infections that would require a delay of ART as judged by the HIV care provider and based on current Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV: such as cryptococcal and Tuberculous meningitis, and CMV retinitis.16
5. Not residing in the state of Missouri at the time of the study or planning to relocate during the study period
6. Incarcerated at the time of the study enrollment.

Site Staff Exclusion criteria:

1\) Moving practice location or job relocation within 1 year

Where this trial is running

Columbia, Missouri and 3 other locations

• University of Missouri-Columbia — Columbia, Missouri, United States (Recruiting)
• KC Care Health Center — Kansas City, Missouri, United States (Recruiting)
• AIDS Project of the Ozarks — Springfield, Missouri, United States (Recruiting)
• NOVUS Health — St Louis, Missouri, United States (Recruiting)

Study contacts

• Principal investigator: Dima Dandachi, MD, MPH — University of Missouri-Columbia
• Study coordinator: Dima Dandachi, MD, MPH

Conditions HIV Infections; ART; Noncompliance, Patient