Clinical trial NCT06374758: Accelerated ART Initiation for PWHIV Who Are Out of Care
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: HIV Infections
ART
Noncompliance, Patient
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2024-04-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: This is 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.

The investigators will assess the effectiveness of achieving HIV viral suppression defined as HIV RNA \< 200 copies/mL at week 24 with B/F/TAF (Biktarvy) as a rapid start for PWH who are out of care.

The investigators will also study the acceptability, feasibility, and sustainability of an innovative model of care that combines a standardized method for outreach, the use of telehealth for rapid access to an HIV care provider, a simplified pre-approved ART regimen, a mailed free starter, and re-linkage to care As an implementation science study, the investigators will explore the methods and factors influencing the successful integration of evidence-based practices across diverse settings.

This study will also ask the staff implementing the ACCELERATE approach about its ease of use, feasibility, compliance, and possible obstacles to its application.

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

Primary outcomes:
measure: The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24.
timeFrame: 24 weeks
measure: To study the change over time in the acceptability of the ACCELERATE model of care in patient and staff participants.
timeFrame: 1 year
measure: To study the change over time in appropriateness of the ACCELERATE model of care in patient and staff participants
timeFrame: 1 year
measure: To study the change over time in feasibility of the ACCELERATE model of care in staff participants
timeFrame: 1 year
measure: To study the change over time in sustainability of the ACCELERATE model of care in staff participants
timeFrame: 1 year
measure: Qualitative data
timeFrame: 1 year
Secondary outcomes:
measure: To evaluate the effectiveness of the intervention to achieve HIV viral suppression at week 48 using ACCELERATE model of care.
timeFrame: 1 year
measure: To assess change in patient experience (PROs) and satisfaction for participants using the ACCELERATE model of care
timeFrame: 1 year
measure: To assess change in health-related quality of life (HRQoL)
timeFrame: 1 year
measure: To measure the change in patients' satisfaction with the HIV treatment regimen B/F/TAF
timeFrame: 1 year
measure: To measure Retention in Care
timeFrame: 1 year
measure: To assess the adherence to the study treatment
timeFrame: 1 year
measure: To study the virologic response of using B/F/TAF as first line regimen in ACCELERATE model of care.
timeFrame: 1 year
measure: To study the immunologic response of using B/F/TAF as first line regimen in ACCELERATE model of care.
timeFrame: 1 year
measure: To assess staff impact of ACCELERATE model of care on staff satisfaction
timeFrame: 1 year
measure: To assess staff impact of ACCELERATE model of care on staff burnout
timeFrame: 1 year
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
city: Kansas City
country: United States
facility: KC Care Health Center
state: Missouri
city: Saint Louis
country: United States
facility: NOVUS Health
state: Missouri
city: Springfield
country: United States
facility: AIDS Project of the Ozarks
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Dima Dandachi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: