Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635421
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
The Expand Study-Pharmacist Administered Long Acting Cabotegravir Rilpivirine to Expand Access for People With HIV
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Expand Study-Pharmacist Administered Long Acting Cabotegravir Rilpivirine to Expand Access for People With HIV
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXPAND
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
Detailed Description:
The EXPAND study will involve three phases
Phase 1 A care delivery model incorporating pharmacist administered CABRPV 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 CABRPV 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 ie 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 CABRPV LA model of care Content of meetings will include introduction to codesign and EXPAND establishment of current workflow for CABRPV LA administration by nurse in clinic determination of essential components production of process map outlining pharmacist administered CABRPV 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 CABRPV LA model will be performed at a pilot site Four patient participants with diverse backgrounds will be enrolled and all will receive their CABRPV LA in the pharmacist administered CABRPV LA model After 1 dose of CABRPV 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 CABRPV LA model
Guided by the Consolidated Framework for Implementation Research CFIR these initial qualitative interviews will focus on illuminating insight to participants ie innovation recipients impressions of specifically the innovation relative advantage eg benefits and quality of the pharmacist-administered CABRPV LA model compared to current practice and innovation adaptability eg 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 CABRPV LA model and the in clinic nurse administered CABRPV LA model will be completed Both patient N140 and staff N20 participants will be enrolled and a mixed methods approach will be performed The decision to initiate CABRPV LA is at the discretion of the patient and their provider ie 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 CABRPV 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 eg how calibrated is the pharmacist-administered innovative treatment to patients clinical and psychosocial needs inner setting eg how do physical and relational infrastructure components of the treatment setting support patients treatment and wellbeing and individuals eg 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
Phase 1 A care delivery model incorporating pharmacist administered CABRPV 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 CABRPV 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 ie 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 CABRPV LA model of care Content of meetings will include introduction to codesign and EXPAND establishment of current workflow for CABRPV LA administration by nurse in clinic determination of essential components production of process map outlining pharmacist administered CABRPV 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 CABRPV LA model will be performed at a pilot site Four patient participants with diverse backgrounds will be enrolled and all will receive their CABRPV LA in the pharmacist administered CABRPV LA model After 1 dose of CABRPV 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 CABRPV LA model
Guided by the Consolidated Framework for Implementation Research CFIR these initial qualitative interviews will focus on illuminating insight to participants ie innovation recipients impressions of specifically the innovation relative advantage eg benefits and quality of the pharmacist-administered CABRPV LA model compared to current practice and innovation adaptability eg 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 CABRPV LA model and the in clinic nurse administered CABRPV LA model will be completed Both patient N140 and staff N20 participants will be enrolled and a mixed methods approach will be performed The decision to initiate CABRPV LA is at the discretion of the patient and their provider ie 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 CABRPV 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 eg how calibrated is the pharmacist-administered innovative treatment to patients clinical and psychosocial needs inner setting eg how do physical and relational infrastructure components of the treatment setting support patients treatment and wellbeing and individuals eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None