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

The EXPAND study will involve three phases:

Phase 1 A care delivery model incorporating pharmacist administered CAB+RPV LA at satellite pharmacies will be developed using codesign. A core group of stakeholders will be engaged in codesigning the intervention. Stakeholders will include HIV physicians, HIV nurses, electronic health record informatics experts, pharmacists, and 3 PWH who are currently receiving CAB+RPV LA. Engaging with patients in codesign ensures patient experience and input is incorporated since the primary goal is improving their health. Bringing stakeholders together to generate solutions ahead of the implementation significantly impacts buy-in.

Codesign team meetings will be convened as hybrid one hour meetings, i.e., in person with option for attendance via virtual platform - Webex or Zoom. There will be 5-6 design team meetings. Number of meetings will depend on progress towards producing a process map outlining the pharmacist administered CAB+RPV LA model of care. Content of meetings will include: introduction to codesign and EXPAND; establishment of current workflow for CAB+RPV LA administration by nurse in clinic; determination of essential components; production of process map outlining pharmacist administered CAB+RPV LA work flow; outlining changes from prior work flow to inform clinical staff education, make changes to electronic health record tools. The final process map will be sent to design team members for verification and additional recommendations.

After the design team work is complete, semi-structured interviews with design team members will be conducted to evaluate the codesign process to improve codesign internally and disseminate findings to inform best practices for conducting codesign activities for models of HIV care delivery and treatment for HIV. These interviews will be performed by trained interviewers from the Population Health Institute at MH. Interviews will take place by phone or in a private room, and audio recordings will later be transcribed verbatim.

Phase 2 After completion of codesign process, a single arm, pilot study of the pharmacist administered CAB+RPV LA model will be performed at a pilot site. Four patient participants with diverse backgrounds will be enrolled and all will receive their CAB+RPV LA in the pharmacist administered CAB+RPV LA model. After 1 dose of CAB+RPV LA are administered by a pharmacist at a satellite MetroHealth pharmacy, semi-structured in-depth qualitative interviews with each participant, pharmacist, and nurse post-pilot will inform the final pharmacist administered CAB+RPV LA model.

Guided by the Consolidated Framework for Implementation Research (CFIR), these initial qualitative interviews will focus on illuminating insight to participants' (i.e., innovation recipients') impressions of, specifically, the innovation relative advantage (e.g., benefits and quality of the pharmacist-administered CAB+RPV LA model compared to current practice) and innovation adaptability (e.g., how participants' experience of receiving pharmacist-administered injections aligns with their own and peers' needs). These interviews will be performed by trained interviewers from the Population Health Institute at MH. Interviews will take place in a private room, and audio recordings will later be transcribed verbatim. This data will be aggregated and utilized to refine the intervention toward maximally appropriate design, complexity, and usability for Phase 3.

Phase 3 Finally, a parallel arm, 48-week, prospective, non-randomized study of the pharmacist administered CAB+RPV LA model and the in clinic nurse administered CAB+RPV LA model will be completed. Both patient (N=140) and staff (N=20) participants will be enrolled and a mixed methods approach will be performed. The decision to initiate CAB+RPV LA is at the discretion of the patient and their provider, i.e. study staff will not participate in this decision.

The Proctor Framework will be used to evaluate implementation outcomes focusing on acceptability, appropriateness, and feasibility. All participants (patients and staff) will complete the previously validated Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM), and staff participants also complete the Feasibility of Intervention Measure (FIM) at baseline, week 16 and 48. CFIR will comprehensively guide semi-structured qualitative interviews to complement the structured surveys and develop a more nuanced understanding of patient and staff perspectives of the novel pharmacist administered CAB+RPV LA model. Interviews of a subset of patient participants will occur at baseline, and 48 weeks. In-depth interview guides will be developed to inquire along specific CFIR domains of innovation (e.g., how calibrated is the pharmacist-administered innovative treatment to patients' clinical and psychosocial needs?), inner setting (e.g., how do physical and relational infrastructure components of the treatment setting support patients' treatment and wellbeing?), and individuals (e.g., how do patients as innovation recipients view treatment innovations as aligning with their own priorities, preferences, and needs?). Interviews of all staff participants will occur 48 weeks after the initial patient participant is enrolled and will focus on facilitators and barriers to sustainability. Interviews will be performed by trained interviewers from the Population Health Department at MH throughout the study. These interviews will take place in a private room, and audio recordings will later be transcribed verbatim.

Approach to participants who switch groups during study: Participants who decide to switch to the other model of care after the entry visit will be allowed to continue on study. Week of switch will be captured. Each switch participant will be approached for qualitative interview to assess reasons for switch. Data will continue to be collected as per schedule of evaluations.

• Facilitators and barriers to model of care [Time frame: Entry, Week 48]
• Organizational facilitators and barriers to sustainability for model of care [Time frame: Week 48]
• Fidelity [Time frame: Week 16, Week 48]
• Fidelity [Time frame: Entry, Week 16, Week 48]
• HIV treatment satisfaction [Time frame: Entry, Week 16, Week 48]
• HIV treatment satisfaction [Time frame: Week 48]
• Quality of life [Time frame: Entry, Week 48]
• HIV stigma [Time frame: Entry, Week 48]
• Virologic suppression [Time frame: Week 16, Week 48]
• Confirmed virologic failure [Time frame: Week 16, Week 48]
• Treatment emergent resistance [Time frame: Week 16, Week 48]
• Adverse events [Time frame: Week 16, Week 48]