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

NCT06635421 | Not Yet Recruiting

• 1 other identifier: STUDY00000459
• Study Type: observational
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

long acting injectable antiretroviral therapy; cabotegravir; rilpivirine; HIV; pharmacist administered medication

Outcome Measures

Primary Outcomes (3)

• Acceptability of intervention

  Acceptability of Intervention Measure (AIM)

  Entry, Week 16, Week 48

• Intervention appropriateness

  Intervention Appropriateness Measure (IAM)

  Entry, Week 16, Week 48

• Feasibility of Intervention

  Feasibility of Intervention Measure (FIM) completed by staff participants only

  Entry, Week 16, Week 48

Secondary Outcomes (21)

• Facilitators and barriers to model of care

  Entry, Week 48

• Organizational facilitators and barriers to sustainability for model of care

  Week 48

• Fidelity

  Week 16, Week 48

• Fidelity

  Entry, Week 16, Week 48

• HIV treatment satisfaction

  Entry, Week 16, Week 48

Study Arms (3)

Patient participants receiving in clinic nurse administered long-acting injectable ART

People with HIV on long acting cabotegravir + rilpivirine who elect to continue to receive their injections in clinic by a nurse

Other: Model of care delivery for long-acting injectable ART

Patient participants receiving pharmacist administered long-acting injectable ART in pharmacy

People with HIV on long acting cabotegravir + rilpivirine who elect to continue to receive their injections in a satellite pharmacy by a pharmacist

Other: Model of care delivery for long-acting injectable ART

Staff participants

Staff involved in the long-acting injectable ART workflow

Interventions

Model of care delivery for long-acting injectable ART OTHER

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).

Patient participants receiving in clinic nurse administered long-acting injectable ART; Patient participants receiving pharmacist administered long-acting injectable ART in pharmacy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient participants will be recruited from the MetroHealth System's HIV provider clinics. Any patient who has decided with their provider to initiate CAB+RPV LA and has received at least two doses of CAB+RPV LA through in clinic nurse administration will be considered for enrollment. Decision to initiate CAB+RPV LA is made by a treating HIV physician with their patient and then is reviewed by an HIV pharmacist. This occurs within the context of clinical care without involvement of the study investigators. Staff participants will be recruited from nursing and physician staff in the HIV clinic, and pharmacy staff at the MetroHealth satellite pharmacies.

You may qualify if:

• years of age and older
• diagnosed with HIV by approved HIV screen and confirmation test
• currently on CAB+RPV LA every 4 or 8 weeks
• has received at least two doses of CAB+PRV LA
• last HIV-1 RNA \<50 copies/ml
• no known or suspected resistance to either cabotegravir or rilpivirine
• no plans to change medication in the next 48 weeks
• no plans to move out of state
• has plans to avoid pregnancy if of reproductive potential

You may not qualify if:

• individuals who are unable or unwilling to adhere to the study protocol
• unable to speak/comprehend English
• insurance coverage for medication through medical benefit

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• ViiV Healthcare: collaborator

Study Officials

• Corrilynn O Hileman, MD

  MetroHealth System, Ohio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corrilynn O Hileman, MD

CONTACT

216-778-7827; chileman@metrohealth.org

Demetria Web

CONTACT

216-778-7827; dwebb@metrohealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of the Infectious Disease Clinic, Associate Professor of Medicine

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 10, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share