None listed
Conditions
Brief summary
The purpose of the ICAROS study is to observe the experiences of patients and health care workers involved in implementing Cabotagravir-Rilpivirine long acting injectable treatment in the Australian setting at both GP clinics and tertiary Institutions. CAB-RPV LA ( Cabeneva) was approved and re-imbursed by the PBS on 1 April 2022 and presents a new HIV treatment paradigm and new challenges in its implementation. Hypothesis: The successful implementation of Cabenuva can be achieved by using a mix of different strategies in both primary & tertiary settings.To achieve this objective.: Patients will complete quality of life and patient satisfaction questionnaires before commencing Cabenuva, after their first injection and at month 12. Health care workers will complete questionnaires at implementation and at month 12. Participants will receive a card with a QR code to enter the study, to consent electronically and will be provided with a unique study number. The data will be stored in RedCap built by the Burnet Institute.To ensure personal information is kept confidential, name, contact details and any other information that allows the participant to be identified directly will be kept separately from all other information collected. Identifying information will not be entered on any study records. Instead, can only be identified by a unique study number. Information will be stored in a secure password protected database at the Burnet Institute where only the research team has access. All data sent to our servers is encrypted and cannot be tempered with or inspected along the way. It is hoped to represent under served groups e g women, ageing, culturally and linguistically diverse community, Aboriginal and Torres Strait Islander communities across Australia.
Interventions
The purpose of this observational study is to observe the experiences of patients and healthcare workers who are involved in the implementation of CAB-RPV LA. The study also will also collate the implementation barriers and solutions to these barriers across the study sites. This study will hope to improve the experience of the patients as well as the health care workers in using this treatment. Information about time required by patients and HCW will also assist HCW plan ahead and find efficien
The purpose of this observational study is to observe the experiences of patients and healthcare workers who are involved in the implementation of CAB-RPV LA. The study also will also collate the implementation barriers and solutions to these barriers across the study sites. This study will hope to improve the experience of the patients as well as the health care workers in using this treatment. Information about time required by patients and HCW will also assist HCW plan ahead and find efficient ways of implementing this treatment. We are achieving this by collecting data on patient reported outcomes, patient satisfaction and quality of life questionnaires before you commence, after your first injection, 6 months and 12 months after commencing Cabenuva to determine if there is an improvement in your experience after 12 months. We have allowed for 20% of participants who have commenced Cabenuva > 1 month ago. If this allocation has been filled, we won’t be able to include any further participants in this category. Patient commitment will be for 3 questionnaires over 12 months. You will be given an Instruction sheet with a QR code to login to the survey website. Once they scan the QR code and enter the survey website, there will be initial question if you are interested in the study, if yes you will be asked to consent to the study. You will be invited to provide their preferred contact details (e-mail or SMS) so that the follow-up surveys can be sent. They will be provided with a unique study number and given a new page to log onto to complete a series of enrolment questions. Then at the 6 month and 12 month time point they will be sent a link via SMS or e-mail to go onto to complete the follow-up questionnaires. Overall the questionnaires should take approx. 15 minutes of your time to complete. Healthcare workers will complete the same process with questionaires at baseline & Month 12 The PI has approached a number of clinic & hospital staff members caring for high numbers of HIV postitive patients to participate. QR cards & brochures will be available at these clinics for both eligible patients & Healthcare workers.
Sponsors
Prahran Market Clinic
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The Principal Investigator has approached GP practises & Hospitals who care for patients living with HIV for their interest in participating & several sites have expressed interest. Participants & Health Care workers who are commencing or recently commenced Cabenuva will be eligible.
Exclusion criteria
HIV positive patients not on Cabenuva & Health Care workers not administrating or prescribing Cabenuva
Outcome results
None listed