The Expand Study-Pharmacist Administered Long Acting Cabotegravir + Rilpivirine to Expand Access for People With HIV

NCT06635421 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 164

Last updated 2024-10-10

No results posted yet for this study

Summary

The purpose of The EXPAND study is to develop and pilot a pharmacist led model of medication delivery. Following a co-design phase, patients may receive injections at satellite pharmacies by a licensed pharmacist. The acceptability, appropriateness, and feasibility of this approach and standard in clinic administration by a nurse will be assessed.

Conditions

  • HIV I Infection

Interventions

OTHER

Model of care delivery for long-acting injectable ART

This study is assessing a novel model of care delivery, i.e. pharmacist administered long-acting cabotegravir + rilpivirine (CAB+RPV LA). In phase 2 and 3, no medication will be provided by the study. The decision to initiate CAB+RPV LA will be at the discretion of the patient and their provider in accordance with both standard of care and local prescribing practices. This will occur independent of study participation. The study intervention is the model of care for CAB+RPV LA administration. The models of care being studied include (1) pharmacist administered CAB+RPV LA in MetroHealth satellite pharmacy setting (novel model of care); (2) nurse administered CAB+RPV LA in the Infectious Diseases clinic at MetroHealth main campus (current standard of care).

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY
  • MetroHealth Medical Center

    lead OTHER

Principal Investigators

  • Corrilynn O Hileman, MD · MetroHealth System, Ohio

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-12-31
Completion
2026-12-31

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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 NCT06635421 on ClinicalTrials.gov