NCT06374758Active, not recruitingPhase 4
Accelerated ART Initiation for PWHIV Who Are Out of Care
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.
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 27 Mar 2024
- Start date
- 29 Apr 2024
- Primary completion date
- 9 Aug 2026
- Lead sponsor
- University of Missouri-Columbia
- Diseases
- HIV
- NCT number
- NCT06374758
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From 29 Apr 2024 to the primary completion date, 9 Aug 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- HIV-2 infection
- 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
Lab values
- 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)
- 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.
- Pregnant (by self-report) or planning to become pregnant while enrolled in the study
Other
- PLWH who are breastfeeding and are not on ART or taking ART without virologic suppression since breastfeeding will not be recommended.
- Not residing in the state of Missouri at the time of the study or planning to relocate during the study period
- Incarcerated at the time of the study enrollment.
- Site Staff Exclusion criteria:
- 1\) Moving practice location or job relocation within 1 year
Criteria the registry did not label
- PLWH Inclusion criteria: Participants must meet ALL the following inclusion criteria
- 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)
- 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
- 18 years or older at the time of obtaining the informed consent
- HIV care providers, case managers, pharmacists, or administrators involved in administrative or clinical aspects of the intervention at participating sites
- Understand the long-term commitment to the study and be willing to participate
- Have adequate resources to complete assessments for the duration of the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Missouri - Columbia Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| KC CARE Health Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| AIDS Project of the Ozarks Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| NOVUS Health Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.