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.
18 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
individuals who are unable or unwilling to adhere to the study protocol
unable to speak/comprehend English
insurance coverage for medication through medical benefit
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.
Cohort
Prospective
Model of care delivery for long-acting injectable ART
Other interventionThis 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).
Acceptability of intervention
Acceptability of Intervention Measure (AIM)
Intervention appropriateness
Intervention Appropriateness Measure (IAM)
Feasibility of Intervention
Feasibility of Intervention Measure (FIM) completed by staff participants only
Facilitators and barriers to model of care
Semi-structured interviews conducted with patient participants
Organizational facilitators and barriers to sustainability for model of care
Semi-structured interviews conducted with staff participants
Fidelity
Proportion of CAB+RPV LA doses entry given within manufacturer's recommended dosing window
Fidelity
Length of injection visits in minutes
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MetroHealth Medical Center
Lead sponsor
ViiV Healthcare
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
