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Accelerated ART Initiation for PWHIV Who Are Out of Care

NCT06374758 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-04-20

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • ART
  • Noncompliance, Patient

Interventions

OTHER

The Accelerate model of care

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.

DRUG

bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg

Same as above, it is the same intervetion

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Dima Dandachi, MD, MPH · University of Missouri-Columbia

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2026-05-01
Completion
2026-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06374758 on ClinicalTrials.gov