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A new Fast-Track HIV care model aims to Re-Engage those lost to care

NCT ID NCT06374758

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study tests a simplified, accelerated HIV care model called ACCELERATE. It combines rapid telehealth appointments, a pre-approved HIV medication, and a free 30-day starter supply to help people with HIV who have fallen out of care get back on track. The goal is to see if this approach can help them achieve viral suppression by week 24 and whether it is acceptable and practical for both patients and staff.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A simplified accelerated HIV care model combining telehealth, a pre-approved HIV medication (B/F/TAF), and a free 30-day starter supply
What this could lead to
If effective, this approach could offer a practical way to re-engage people with HIV who have fallen out of care, helping them achieve viral suppression and better long-term health.
What could go wrong
The trial is relatively small and single-arm, so results may not apply broadly. Success depends on factors like patient adherence and the feasibility of the model in different settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AIDS Project of the Ozarks

    Springfield, Missouri, 65804, United States

  • KC Care Health Center

    Kansas City, Missouri, 64124, United States

  • NOVUS Health

    St Louis, Missouri, 63111, United States

  • University of Missouri-Columbia

    Columbia, Missouri, 65212, United States

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